• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $130,000.00 - $150,000.00

Position Summary

The Clinical Research Manager (CRM) oversees operational management of clinical research studies conducted within the CICET Cell & Gene Therapy Trials Management (CGTM) at Columbia University Irving Medical Center (CUIMC).

Reporting to the CICET CGTM Senior Research Nurse Manager, the CRM leads the coordination and execution of investigator-initiated and industry-sponsored clinical trials, ensuring compliance with Good Clinical Practice (GCP), FDA regulations, institutional policies, and sponsor requirements.

The CRM supervises clinical research coordinators, manages study operations across multiple trials, and collaborates with investigators, regulatory teams, research pharmacy, and clinical departments to ensure the successful implementation of complex cell and gene therapy clinical trials. This role supports high-quality data collection, regulatory compliance, patient-centered research operations, and efficient study execution across CICET clinical programs.

Responsibilities

Clinical Trial Operations and Study Management

• Manage the operational execution of multiple clinical research studies, including participant recruitment, consent, enrollment, and follow-up activities.
• Coordinate cross-functional collaboration between clinical research teams and institutional departments, including apheresis, cell therapy laboratories, interventional radiology, research pharmacy, inpatient units, and outpatient clinics.
• Coordinate clinical research visits, study procedures, and specimen collection in accordance with protocol requirements.
• Support study feasibility assessments, start-up activities, and operational planning for new cell and gene therapy clinical trials.
• Develop new and optimize existing study workflows, operational tools, and standard operating procedures to support efficient research operations.
• Run regular internal clinical research meetings across the multidisciplinary research team regarding new and existing study activities.

Regulatory Compliance and Quality Oversight

• Ensure compliance with Good Clinical Practice (GCP), HIPAA, IRB, sponsor, and institutional regulatory requirements.
• Ensure research compliance with Foundation for the Accreditation of Cellular Therapy (FACT) guidelines.
• Act as liaison with internal institutional partners (Office of Human Research Protection and Institutional Review Board (IRB)).
• Startup, management, and closing of cell therapy clinical trials. Review participant eligibility, consent documentation, and study data to ensure protocol adherence.
• Monitor and document protocol deviations, adverse events, and regulatory issues as required.
• Support corrective and preventive action (CAPA) processes and maintain readiness for internal and external audits.
• Coordinate investigational product management and documentation in collaboration with pharmacy and clinical teams.

Data Management and Reporting

• Maintain accurate and complete research documentation and regulatory records.
• Track study activities and milestones using clinical trial management systems (CTMS) and regulatory platforms.
• Prepare study progress reports, sponsor updates, and institutional reporting documentation.
• Support data collection and reporting for IRB submissions, sponsor requirements, and feasibility assessments.
• Support monitoring visits, sponsor audits, and regulatory inspections.

Financial and Administrative Management

• Assist in tracking clinical trial budgets, participant payments, and study-related expenses.
• Monitor CTMS billing activities and collaborate with research finance teams and Clinical Trials Office (CTO) finance to resolve discrepancies.
• Track study financial performance, including enrollment-driven revenue.
• Assist in the management of pre-award, post-award, and close-out of all sponsored resources.
• Support administrative processes related to study start-up, monitoring visits, and sponsor communications.

Staff Supervision and Team Leadership

• Provide direct supervision and mentorship to Clinical Research Coordinators.
• Conduct performance appraisals, provide ongoing feedback, and support professional development.
• Manage staff scheduling and time-off approvals in accordance with institutional policies.
• Address performance concerns in collaboration with Human Resources when necessary.
• Foster a collaborative, inclusive, and supportive team environment.

Stakeholder Collaboration

• Build and maintain effective relationships with investigators, clinical teams, research administrators, and sponsors.
• Serve as a liaison with regulatory, CTO finance, research pharmacy, apheresis, cell therapy labs, infusion center, inpatient, and outpatient service to ensure efficient study execution.
• Contextualize institutional workflows with external study sponsors and investigators.
• Support continuous improvement of research workflows and operational processes within CICET clinical research programs.

Other Duties

• Participate in on-call or off-hours responsibilities when required by study activities.
• Perform additional duties as assigned to support CICET research and institutional objectives.

Minimum Qualifications

• Bachelor’s degree in health sciences, life sciences, public health, nursing, or a related field, or equivalent combination of education and experience.
• Minimum 4 years of clinical research experience, preferably in an academic medical center or regulated clinical research environment.
• Demonstrated experience coordinating complex clinical trials from study start-up through close-out.
• Strong knowledge of Good Clinical Practice (GCP), HIPAA, IRB processes, and clinical research regulatory requirements.
• Excellent organizational, analytical, and problem-solving skills with the ability to manage multiple concurrent projects.
• Strong interpersonal and communication skills with the ability to collaborate effectively across multidisciplinary teams.
• Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, Teams, OneDrive, and SharePoint.
• Ability to learn and utilize clinical research systems and databases.
• Commitment to fostering equitable and inclusive research environments.
• Advanced knowledge of medical terminology and procedures.
• Willingness to obtain Clinical Research Coordinator certification from ACRP, SOCRA, or equivalent organization.

Preferred Qualifications

• Master’s degree in Health Sciences with 6 years of related clinical research experience or equivalent.
• Supervisory or leadership experience managing clinical research staff.
• Experience supporting cell and gene therapy clinical trials or complex biologics studies.
• Familiarity with Columbia University research and clinical systems.
• Experience with research platforms such as Epic, REDCap, Qualtrics, iLab, or OpenSpecimen.
• Clinical research certification (ACRP, SOCRA, or equivalent) or obtained within one year of hire.
• Bilingual proficiency in Spanish and English.
• Phlebotomy certification from a nationally recognized organization. (e.g., NHA)
• BLS or ACLS certification from a nationally recognized organization.

Other Requirements

• Medical clearance and participation in the medical surveillance program.
• Direct patient contact and/or interaction with human research subjects.
• Potential exposure to bloodborne pathogens.
• Successful completion of all required compliance and systems training.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.