Writing.io Jobs

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Start-Up Associate II (SUA II) to join our A-team (hybrid*/remote) in Italy! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

In this role your key tasks will include:

• Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)

• Ensure planned dates are reliable and up to date in CTMS departments/study teams

• File documents in the (e)TMF for which they are the document owner

• Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner

• Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level

• Provide relevant documents in compliance with local regulation

• Support review of technical, pre-clinical and clinical reports for regulatory submissions

• Interact with regulatory authorities

• Prepare and compile answers for questions raised by the regulatory agencies and submit the answers

• Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate

• Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed

• Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level

• Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation

• Interact with IEC/IRB

• Prepare and compile answers for questions raised by the IEC/IRB and submit the answers

• Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate

• Assist in adapting country SIS/ISF to site-specific requirements

• Provide country specific requirements to GSCM impacting site contracts’ process

• Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study

• Negotiate within client approved contract and budget templates and negotiation parameters

• Communicate with sites and internal personnel regarding the status of contracts and contract related documents

• Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable

• Provide the final/draft CTA and site budget for submission, where required

• Obtain site signature as well as Sponsor/Allucent signature, as applicable

• Keep up to date with applicable local regulations impacting clinical trial contracts

• Assist in preparing the site-specific Essential Document Package and sending to sites

• Responsible for collection and first review of Essential Documents

• Provide the Global Essential Document Reviewer with the collected documents for independent review

• Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution

• Obtain authorization for the shipment of Investigational Product to the site

• Track relevant information and data in CTMS and/or other tracking tools

To be successful you will possess:

• Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
• More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
• A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
• A thorough understanding of the drug development process
• Good oral and written communications skills - fluent in Italian and English.
• Attention to detail.
• Able to perform well as a team member.

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-BL1

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Start-Up Associate Contractor to join our A-team (hybrid*/remote) for 0.5 Fte! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

In this role your key tasks will include:

• Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)

• Ensure planned dates are reliable and up to date in CTMS departments/study teams

• File documents in the (e)TMF for which they are the document owner

• Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner

• Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level

• Provide relevant documents in compliance with local regulation

• Support review of technical, pre-clinical and clinical reports for regulatory submissions

• Interact with regulatory authorities

• Prepare and compile answers for questions raised by the regulatory agencies and submit the answers

• Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate

• Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed

• Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level

• Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation

• Interact with IEC/IRB

• Prepare and compile answers for questions raised by the IEC/IRB and submit the answers

• Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate

• Assist in adapting country SIS/ISF to site-specific requirements

• Provide country specific requirements to GSCM impacting site contracts’ process

• Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study

• Negotiate within client approved contract and budget templates and negotiation parameters

• Communicate with sites and internal personnel regarding the status of contracts and contract related documents

• Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable

• Provide the final/draft CTA and site budget for submission, where required

• Obtain site signature as well as Sponsor/Allucent signature, as applicable

• Keep up to date with applicable local regulations impacting clinical trial contracts

• Assist in preparing the site-specific Essential Document Package and sending to sites

• Responsible for collection and first review of Essential Documents

• Provide the Global Essential Document Reviewer with the collected documents for independent review

• Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution

• Obtain authorization for the shipment of Investigational Product to the site

• Track relevant information and data in CTMS and/or other tracking tools

To be successful you will possess:

• Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
• More than 5 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
• Experience with contract negotiation.
• A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
• A thorough understanding of the drug development process
• Good oral and written communications skills - fluent in Bulgarian and English.
• Attention to detail.
• Able to perform well as a team member.

Disclaimers:

*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-BL1

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

Eurofins BPT-Columbia is seeking a Deviations & Investigations Scientist to join our Chemistry team in Columbia, Missouri. This partially remote position is responsible for supporting laboratory investigations, deviation management, stability studies, and batch release activities within a GMP-regulated environment.

The Deviations & Investigations Scientist serves as a key contributor to quality and compliance initiatives by leading and documenting investigations associated with laboratory deviations, out-of-specification (OOS) results, out-of-trend (OOT) findings, atypical results, and other quality events. This role partners closely with laboratory operations, Quality Assurance, and technical teams to identify root causes, assess impact, implement corrective and preventive actions (CAPAs), and maintain compliance with regulatory expectations.

This intermediate-level position combines scientific expertise with technical writing, data analysis, and quality systems knowledge. The successful candidate will independently manage investigations, review analytical data, support stability and batch release programs, and contribute to continuous improvement efforts while ensuring data integrity and adherence to GMP requirements.

Key Responsibilities

• Lead and author laboratory investigations related to deviations, OOS, OOT, atypical results, and quality events.
• Perform root cause analyses and support development and implementation of CAPAs.
• Review analytical data and laboratory documentation to support investigation conclusions.
• Support stability testing and batch release activities through data review and quality assessments.
• Collaborate with laboratory, quality, and operational teams to resolve technical and compliance issues.
• Ensure investigations are completed accurately, thoroughly, and within established timelines.
• Maintain compliance with GMP, GLP, regulatory, client, and internal quality requirements.
• Utilize LIMS and quality systems to manage documentation and maintain records.
• Prepare technical reports, investigation summaries, and supporting quality documentation.
• Identify quality trends and contribute to process improvements and operational excellence initiatives.

Qualifications

The ideal candidate would possess:

• Experience with GLP and/or GMP and hands-on experience with HPLC and/or GC desirable.
• Experience with LIMS system desirable.
• Familiarity and/or experience in a laboratory setting is required.
• Good organizational skills; ability to follow direction and good communication skills are required.
• Ability to work on multiple on-going projects.

Minimum Qualifications:

• Bachelor’s degree in relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework in the above areas.
• 1-3 years of experience working in a cGMP compliant lab
• Authorization to work in the US indefinitely without restriction or sponsorship

Additional Information

Position is full-time position, Monday - Friday 8:00am - 4:30pm. Candidates currently living within a commutable distance of Columbia, MO are encouraged to apply.

Excellent full time benefits including

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Start-Up Associate Contractor to join our A-team (hybrid*/remote) for 0.5 Fte! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

In this role your key tasks will include:

• Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)

• Ensure planned dates are reliable and up to date in CTMS departments/study teams

• File documents in the (e)TMF for which they are the document owner

• Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner

• Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level

• Provide relevant documents in compliance with local regulation

• Support review of technical, pre-clinical and clinical reports for regulatory submissions

• Interact with regulatory authorities

• Prepare and compile answers for questions raised by the regulatory agencies and submit the answers

• Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate

• Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed

• Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level

• Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation

• Interact with IEC/IRB

• Prepare and compile answers for questions raised by the IEC/IRB and submit the answers

• Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate

• Assist in adapting country SIS/ISF to site-specific requirements

• Provide country specific requirements to GSCM impacting site contracts’ process

• Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study

• Negotiate within client approved contract and budget templates and negotiation parameters

• Communicate with sites and internal personnel regarding the status of contracts and contract related documents

• Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable

• Provide the final/draft CTA and site budget for submission, where required

• Obtain site signature as well as Sponsor/Allucent signature, as applicable

• Keep up to date with applicable local regulations impacting clinical trial contracts

• Assist in preparing the site-specific Essential Document Package and sending to sites

• Responsible for collection and first review of Essential Documents

• Provide the Global Essential Document Reviewer with the collected documents for independent review

• Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution

• Obtain authorization for the shipment of Investigational Product to the site

• Track relevant information and data in CTMS and/or other tracking tools

To be successful you will possess:

• Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
• More than 5 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
• Experience with contract negotiation.
• A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
• A thorough understanding of the drug development process
• Good oral and written communications skills - fluent in Spanish and English.
• Attention to detail.
• Able to perform well as a team member.

Disclaimers:

*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-BL1

Company Description

At Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace. This patient-first approach is what sets us apart as a leader in the healthcare industry. As an integral part of our team, you’ll have the opportunity to join our quest for better health care, no matter where you work within the Northwestern Medicine system. We pride ourselves on providing competitive benefits: from tuition reimbursement and loan forgiveness to 401(k) matching and lifecycle benefits, our goal is to take care of our employees. Ready to join our quest for better?

Job Description

The hours for this position are 8:00AM to 4:30PM or 8:30AM to 5:00PM

During the orientation period, this position will be in person. After orientation, the position will be hybrid.

The Referral Specialist reflects the mission, vision, and values of NM, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.

Responsibilities:

• Consistently practices Patients First philosophy and adheres to high standards of customer service. This includes setting an example to peers, coworkers, etc. by fostering a team atmosphere.
• Responds to questions and concerns.
• Forwards, directs and notifies Team Lead or Operations Coordinator of extraordinary issues as necessary.
• Maintains patient confidentiality per HIPAA regulations.
• Provides exceptional customer service to consumers which establishes a positive first impression of Northwestern Medicine.
• Exceed all consumer requests and alert management of issues or concerns that require escalation.
• Appropriately triages telephone inquiries requesting medical services and/or physician referral/appointment to determine level of urgency/acuity and type of physician needed for stated problem.
• Maintains sufficient medical knowledge base with ability to recognize urgent clinical situations and demonstrate communication skills necessary to make appropriate physician referrals to potential patients.
• Assists consumers in scheduling and registering for patient appointments.
• Registers and educate consumers on classes in programs offered by.
• Securely process consumers credit card information accurately with PCI compliance standards upon class registration.
• Educates consumers about additional NMHC services that may meet a patients needs.
• Obtains knowledge about hospital product lines and medical staff to enable cross marketing of services.
• Participate in training programs as new product lines are introduced.
• Maximize opportunities to cross-sell NM services.
• Direct consumers to the NMHC website for additional information as needed.
• Protects the integrity of the proprietary database by entering and updating all consumer/physician demographic information correctly to avoid duplicate or inaccurate records.
• Document codes for all consumer transactions to accurately track call types and effectiveness of all programs.
• Maintain a current and up-to-date knowledge with health care plans to accurately make physician referrals to patients according to their carrier.
• Assist patients on requirements of their particular plans e.g. HMO, IPA and identify alternative resources if needed.
• Other duties as assigned.
• Communication and Collaboration:
  • Keep abreast of all daily correspondence to ensure that consumers are receiving accurate and up to date information.
  • Keep fellow team members informed of all pertinent changes to procedures or any new insights into clinical issues.
  • Interface with various hospital departments and physician offices while directing consumers and physicians through the Northwestern Medicine organization.
• Technology:
  • Utilize Epic and any other appropriate scheduling systems to register patient, schedule appointments, and verify insurance.
  • Respond to Internet requests from consumers.
• Efficiency, Process Improvement, and Business Growth:
  • Maintain the department average for all individual quality goals including contact center metrics, appointment scheduling, database accuracy, and quality monitoring.
  • Focus on continual process improvements for assigned responsibilities to achieve optimal outcomes.
  • Completes telephone contacts to exceed expectations of callers.
  • Monitors queue status closely to minimize wait time of caller.

Qualifications

Required:

• High school diploma or equivalent.
• 2-3 years of Customer Service in Contact/Call Center and/or medical staff office and computer experience.
• Excellent customer service skills.
• Excellent interpersonal, verbal, and written communication skills.
• Proficiency in computer data-entry/typing.
• Excellent verbal and written communication skills.
• Ability to read, write, and communicate effectively in English.
• Basic computer skills.
• Ability to type 40 wpm.
• Ability to multi-task.
• Customer service oriented.
• Excellent organizational, time management, analytical, and problem solving skills.

Preferred:

• Bachelor’s degree.
• Additional language skills.
• Healthcare finance and/or healthcare insurance experience.
• Knowledge and experience in a healthcare setting, especially patient scheduling and/or registration.
• Additional training in health care, marketing, or communication.
• Familiarity with health care plans and managed care.

Additional Information

Northwestern Medicine is an equal opportunity employer (disability, VETS) and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.

Background Check

Northwestern Medicine conducts a background check that includes criminal history on newly hired team members and, at times, internal transfers. If you are offered a position with us, you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check.  Results are evaluated on a case-by-case basis, and we follow all local, state, and federal laws, including the Illinois Health Care Worker Background Check Act.

Artificial Intelligence Disclosure

Artificial Intelligence (AI) tools may be used in some portions of the candidate review process for this position, however, all employment decisions will be made by a person.

Benefits

We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events.

Click on or copy and paste URL to your browser to view detailed benefits information

NorthwesternMedicine Career Page

https://jobs.nm.org/benefits

Please refer to the Benefits Eligibility by Employment Classification to determine benefits eligibility for job postings.

If sign-on bonus is included in a job posting eligibility is as followed: Internal employees and rehires who left Northwestern Medicine within 1 year are not eligible for the sign-on bonus. Exception: New graduate internal employees seeking their first licensed clinical position as a Registered Nurse at NM may be eligible.

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

Our experienced and collaborative Medical Affairs team is seeking an innovative and highly motivated Senior Medical Science Liaison (Senior MSL) or Field Medical Affairs Director with assisting in building the foundation for the field capabilities of the medical affairs organization. In addition, the position will provide clinical/medical information to healthcare professionals in response to inquiries regarding Caribou’s cellular therapy pipeline across hematology/oncology indications.

Please note that the field territory for this position will cover certain geographic regions in the US and ex-US based on business need.

Principal Responsibilities:

• Medical advocate for Caribou by utilizing disease state knowledge, detailed understanding of investigational cellular therapy product(s) to engage healthcare providers during scientific exchange
• Identify, build and maintain successful relationships with clinical investigators, key opinion leaders and academic center(s) research personnel
• Engage and educate pivotal trial sites at both academic and community centers to support start up activities
• Prioritize solutions to challenging scenarios and develop mitigation strategies to support the needs of the healthcare team
• Must be able to support any type of medical affairs project (ie- trial protocol development, publications support, training) irrespective of complexity and have the ability to escalate issues to senior leaders as needed
• Provide detailed, clear and regular communication to headquarter medical team and have the ability to deliver complex medical/scientific information effectively to health care providers

Qualifications:

• Advanced science degree required (PhD, PharmD, MD, RN, NP, PA or equivalent), with:
  • Senior MSL requires 5+ years relevant pharma and/or clinical experience, including 2+ years as field medical science liaison or equivalent
  • Field Medical Director requires 10+ years of relevant pharma and/or clinical experience, including 5+ years in a field medical science liaison role or equivalent
• Must have prior cellular therapy experience in hematology/oncology
• Excellent verbal, written and interpersonal communication skills
• Demonstrated skill in managing multiple tasks simultaneously with minimal guidance and oversight
• Ability to deliver scientific and clinical presentations to many types of audiences
• Can independently manage projects and work well with cross-functional team members to achieve corporate and department objectives
• Demonstrated positive, collaborative attitude with all internal and external stakeholders
• Must be able and have flexibility to travel all over the US (and potential ex-US based on business need) for medical congress coverage, exhibit booth staffing as well as support headquarter team with clinical site visits depending on business needs (may require weekend travel depending on medical congress schedule)
• Ability to work well under pressure given time constraints
• Must work effectively in a cross-functional team environment
• Ability to proactively identify issues and have a solutions-oriented approach

Nice-to-haves:

• Established rapport with cell therapy clinicians within territory
• Leadership experience managing direct reports
• Experience with medical writing, publication development, managing medical/legal/regulatory reviews of externally facing scientific materials
• Experience collaborating with cross functional teams including clinical development & research and clinical operations to support clinical trial site outreach and recruitment

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range:
  • Senior MSL: $220,000 - $240,000
  • Field Medical Affairs Director: $238,000 - $255,000
  • These represent the present low and high end of the Company’s pay range for this position; actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance
• Generous paid vacation time, in addition to company-observed holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

• We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.

Company Description

Join One of New York’s Most Awarded Mental Health Employers!

At NYPCC , we’re not just changing lives, we’re redefining what it means to build a meaningful career in mental health.

🏆2025 and 2026 City & State Top Workplace in New York

🏆 Mental Health America’s Platinum Bell Seal recipient for FIVE consecutive years

🏆 Serving 15,000+ clients every month

🏆 50+ years of transforming lives across New York City

If you’re looking for more than just your next job, you’ve found it.

For over five decades, New York Psychotherapy and Counseling Center (NYPCC) has been one of New York’s leading community mental health organizations, delivering innovative, compassionate care through both in-person and telehealth services. Today, we proudly serve more than 15,000 clients each month while continuing to set the standard for clinical excellence and employee experience.

At NYPCC, you’ll find:

• Competitive compensation and outstanding benefits
• Career growth through our Academy and leadership development programs
• A collaborative, mission-driven culture where our employee matters
• The chance to make a lasting impact on thousands of lives every single day

Come build a career where purpose meets possibility!

Job Description

This is a full-time position that will be located at our new Child and Family Mental Health Clinic in Jackson Heights (Queens, NY).

Responsibilities:

• Provide therapy to an ethnically and culturally diverse population of children, adolescents, and adults
• Develop, implement, and review treatment plans
• Write progress notes for all sessions conducted
• Evaluate and assess clients
• Maintain and update clinical records
• Provide case management and/or crisis intervention
• Attend clinical supervision and staff meetings
• Perform other duties as assigned by Supervisor

Qualifications

• Master’s Degree from an accredited school in Social Work, or Mental Health Counseling is a must
• LMSW, LCSW, MHC, MHC-LP or LMHC’s are welcome to apply
• Outstanding engagement, interpersonal communication skills, and ability to work collaboratively with other disciplines, including clinical and clerical staff
• Ability to manage time effectively to ensure documentation compliance
• Exceptional writing skills
• Proficient in Microsoft Office, including Outlook, Word, Excel, and PowerPoint
• Strong entrepreneurial work ethic
• Dedication to workplace mentorship, education, and team-based care
• Maintains a positive attitude and is friendly, upbeat, and has a great “can do” personality
• Able to work well in a fast-paced environment
• Adheres to professional ethics
• Passionate about NYPCC’s mission and values

Additional Information

Salary: $72,800 - $100,000 per year

Compensation commensurate with experience and qualifications.

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives.

Summary of Role: In this Clinical Research Associate role, you will be responsible for monitoring the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

We are recruiting for two roles: one based on the West Coast and one based on the East Coast. Travel expected: ~1+ site visit per week, for sites that do not permit virtual monitoring.

Responsibilities:

• May serve as the primary monitor and main point of contact for assigned clinical sites
• Conduct interim monitoring visits (IMVs) and ISF review
• Review electronic medical records (EMR)/patient data
• Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
• Provide support to site staff including research coordinators and physicians
• Assist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides)
• Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
• Author and submit high-quality monitoring visit reports within required timelines
• Ensure completeness and accuracy of monitoring documentation in the eTMF

Qualifications:

• BA/BS or equivalent with a minimum of 2+ years of CRA experience (for CRA role) or 5+ years with lead monitor responsibilities (Senior CRA)
• Therapeutic experience in oncology/hematology and cell and gene therapy preferred
• Prior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibility
• Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
• Experience with Trial Master File management according to the DIA reference model
• Experience operating within various site EMR/EHR systems
• Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals, as well as working on trials without a CTMS in place

Personal Qualities:

• Highly detail oriented with special attention to quality and quality control
• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
• Well organized and able to work under tight deadlines
• Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
• Strong interpersonal skills, including verbal and written communication, are essential
• Ability to work in a collegial and collaborative manner; independently and as part of a team
• Ability to work in a fast-paced and informal startup environment
• Highly tolerant and respectful of all members of our team
• Strong problem-solving skills with desire to improve upon established processes
• Sense of humor

$90,000 - $140,000 a year

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.