Clinical Research Study Activations Coord

Temple Health – Temple University Health System; Philadelphia (Philadelphia County); On-site; USD 70,000 - 90,000; Full time

Job summary

A healthcare organization is seeking a Study Activations Project Coordinator to coordinate clinical research initiatives in Philadelphia. This role involves managing study start-up and related submissions, overseeing committee activities, and ensuring compliance with regulatory standards. Candidates should possess a Bachelor's Degree and relevant experience in project coordination, preferably in clinical research or oncology. The position offers a full-time employment opportunity with a mid-senior level responsibility.

Qualifications

• Bachelor's Degree required; relevant education and experience may substitute.
• 5 years experience with computer programs, particularly Microsoft Suites.
• 1+ years experience coordinating Clinical Trial Management System activities.

Responsibilities

• Coordinate study pipeline activities and TRACSS approval process.
• Submit protocols and regulatory documents into CTMS.
• Manage feasibility and review committee meetings and correspondence.

Skills

Coordination

Regulatory compliance

Data management

Meeting management

Education

Bachelor's Degree

Tools

Microsoft Office Suite

Clinical Trials Management System

Job description

Study Activations Project Coordinator – Temple Health – Temple University Health System

The Study Activations Project Coordinator for the Office of Clinical Research (OCR) coordinates initial study start-up and submission activities, including work with the Research Review Committee (RRC), the Feasibility Committee, and the Accrual sub-committee.

Responsibilities

• Coordinate the new study pipeline activities and the Trial Allocation and Capacity Support System (TRACSS) approval process.
• Accurately compile and submit protocols and related regulatory documents into the Fox Chase Cancer Center (FCCC) Clinical Trials Management System (CTMS), i.e., Oncore.
• Ensure all materials required for committee reviews (including the FCCC Institutional Review Board) are complete.
• Manage meetings of feasibility, RRC, and Accrual committees: prepare agendas, coordinate reviewer assignments, monitor attendance, and produce minutes.
• Oversee all committee correspondence and ensure completion of committee tasks.
• Support the maintenance of accurate records for clinical trial reporting and compile data for necessary Cancer Center Support Grant (CCSG) metric reporting.

Education

• Bachelor's Degree Required.
• Combination of relevant education and experience may be considered in lieu of degree.

Experience

• 5 years experience with computer programs, particularly Microsoft Suites or related.
• 1 year experience with project coordination or involvement with implementing projects.
• 1 year experience coordinating Clinical Trial Management System activities.
• 1 year experience in Clinical Research.
• 2 years experience in a research or healthcare-related office setting, preferably oncology or clinical trials.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Other