Clinical Research Regulatory Coordinator---Cancer Center Protocol Office

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Regulatory Coordinator. The Cancer Center Protocol Office is a centralized research office that supports clinical researchers in all disciplines within the Cancer Center. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.

The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The following regulatory duties will be performed under general supervision by the Clinical Research Manager:

• Maintain and organize study specific regulatory binders

• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB

• Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study

• Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required

• Submit Data and Safety Monitoring Reports

• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process

• Collect, complete, and submit essential regulatory documents to various regulatory entities

• Participate in monitoring visits and file all monitoring visit correspondence

• Ensure appropriate documentation of delegation and training for all study staff members

• Maintain screening and enrollment logs

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Careful attention to detail

• Good organizational skills

• Ability to follow directions

• Good communication skills

• Computer literacy

• Working knowledge of clinical research protocols

EDUCATION:

• BA/BS degree required

EXPERIENCE:

• None

SUPERVISORY RESPONSIBILITY:

• None

WORKING CONDITIONS:

• Please note that this is a remote role and there will be no work at the physical office/location. Applicants may work in all states with the following exceptions: WY, ND, Puerto Rico, and the U.S. Virgin Islands.