Senior Clinical Research Coordinator - Cell Therapy

Department:

Comprehensive Integrated Research Operations (CIRO)

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Administration

Position Title:

Senior Clinical Research Coordinator - Cell Therapy

Job Family Group:

Professional Staff

Job Description Summary:

This position is responsible for working collaboratively with multidisciplinary teams research and hospital staff to recruit screen educate and assist in the overall clinical study coordination of clinical research. The Clinical Research Coordinator Senior will manage clinical research studies by coordinating and overseeing a variety of complex activities involved in the collection compilation documentation and analysis of clinical research data. Participate in periodic quality assurance audits of protocols. Assist with study budgets and contracts and assist with grant applications.

Job Description:

Position Summary:

The Senior Clinical Research Coordinator (Sr. CRC) plays a key-role in complex clinical trials focused on cellular therapies including CAR-T and other investigational treatments. As part of a centralized research team supporting multiple departments and medical specialties the Sr. CRC collaborates with multidisciplinary teams to coordinate all aspects of clinical research with a high degree of autonomy. Responsibilities include serving as the primary liaison with sponsors and investigators leading participant recruitment and coordination ensuring regulatory compliance managing data and quality audits and supporting the development of study budgets contracts and grant applications.

Job Duties:

Cell Therapy Clinical Trial Management

• Independently manage all operational aspects of multiple clinical trials from initiation through close-out.
• Collaborate on developing and implementing centralized support for cell therapy and early-phase trials.
• Coordinate and track essential regulatory and study documentation to ensure audit and monitoring readiness.
• Create and maintain study binders source documentation templates and other regulatory-compliant materials.
• Participate in site selection initiation monitoring and close-out visits with sponsors and research partners.
• Facilitate protocol feasibility assessments and coordinate site qualification documentation.
• Serve as primary liaison among sponsors research partners and internal departments.
• Support feasibility by gathering and analyzing data on patient populations and operational needs.
• Develop and update standard operating procedures guidelines and source documents.

Participant Coordination & Oversight

• Conduct prescreening recruitment informed consent and enrollment in collaboration with investigators.
• Educate and evaluate potential participants for trial eligibility under investigator direction.
• Ensure adherence to protocol during study visits including specimen collection investigational product accountability and accurate data recording.
• Perform study procedures within regulatory and institutional scope of practice.
• Provide ongoing participant support to ensure retention and address questions or concerns.
• Identify document and report adverse events protocol deviations and unexpected issues to the principal investigator.
• Assist principal investigators in timely regulatory reporting of adverse events and deviations.

Regulatory Affairs Data Management & Quality Assurance

• Prepare and assist with regulatory submissions amendments and continuing reviews.
• Maintain up-to-date and audit-ready regulatory binders and documentation systems.
• Conduct regular self-audits and internal quality reviews to ensure protocol and procedure compliance.
• Lead internal audits and support external monitoring visits audits and regulatory inspections.
• Ensure accurate and timely data entry and reconciliation between source documents and study databases.
• Maintain source documentation and prepare case report forms for clinical trial reporting.

Administrative & Financial Oversight

• Collaborate with investigators to provide input for study budgets and contract development.
• Manage clinical trial contract documentation and budget tracking.
• Oversee study supply inventory and coordinate procurement as needed.
• Submit reimbursement requests for study-related expenses including participant stipends and equipment.
• Maintain accurate financial records to support timely payments and billing compliance.
• Respond to financial inquiries and assist with invoice reconciliation and reporting.

Leadership & Mentorship

• Provide direction and oversight to other research staff.
• Assist with onboarding and training of new team members.
• Participate in process improvement initiatives and contribute to the development and refinement of standard operating procedures.

This job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job not an exhaustive list of all possible job responsibilities tasks duties and assignments. Furthermore job duties responsibilities and activities may change at any time with or without notice.

Required Qualifications

Education:

• Associates degree and six (6) years of relevant experience
  OR
• Equivalent combination of post-secondary education and work experience totaling at least eight (8) years
• Education may be substituted for experience on a year for year basis.

Certifications (one or more of the following):

• Certified Clinical Research Coordinator (CCRC)
• Certified Clinical Research Professional (CCRP)

Work Experience:

• Experience coordinating clinical trials
• Experience with FDA GCP HIPAA and IRB regulations and guidelines
• Experience with study budgets contracts and grant submissions
• Experience coordinating monitoring visits audits and inspections
• Experience with early phase and/or complex therapeutic trials (e.g. inpatient oncology or cell therapy)

Preferred Qualifications

Education:

• Bachelors degree in health sciences biological sciences nursing or related field

Work Experience:

• Experience with cellular therapy clinical trials including CAR-T or investigational biologics
• Experience working within a centralized research model or multi-departmental trial coordination
• Experience supporting clinical trials involving high-risk investigational products

Skills

• Organization
• Attention to Detail
• Project Management
• Data Analysis
• Communication
• Interpersonal Skills
• Leadership
• Computer Skills

Required Documents

• Resume/CV
• Cover Letter

Comprehensive Benefits Package: