PROGRAM COORDINATOR, NCORP

The Program Coordinator, NCORP supports National Cancer Institute Community Oncology Research Program (NCORP) Clinical Trial Regulatory Research activities, under direction of the Program Administrator for NCORP. Conducts routine audits, prepares site regulatory documents, and provides updates on new protocols undergoing Institutional Review Board (IRB) review.

TYPICAL DUTIES

• Collaborates with NCORP Administrator to coordinate Clinical Trial Regulatory Research matters, providing support and clinical trial updates to the NCORP team.
• Liaisons with CIRB, CCH IRB and the Director of Research and Regulatory Affairs to track receipt of ALL approval letters regarding annual renewal, amendments/addenda, and consent form changes and study updates.
• Assists with the agenda planning and conduct of NCORP Clinical Trials working group meeting, which includes scheduling bi-weekly meetings.
• Performs searches for all clinical trial updates, study closures, amendments, consent updates, new study activations.
• Monitors training or credentialing requirements to ensure staff remain in compliance as outlined in the protocol.
• Ensures collaboration agreement/feasibility with Pathology, Pharmacy and other collaborators.
• Collaborates with staff to manage the Delegation of Task Logs (DTLs).
• Provides updates and necessary follow-up on new protocols undergoing Institutional Review Board review.
• Completes all necessary administrative documentation for opening new protocols, including obtaining required signatures, obtaining Clinical IRB approval, and submitting required information through the IRB Manager website.
• Prepares site regulatory documents ensuring completeness and accuracy.
• Maintains electronic study binders according to protocol requirements and department policy.
• Completes informed consent documents with approved boilerplate language and updates. consent forms daily due to addendum updates, saves all updated consent forms in appropriate folders.
• Provides copies of patient informed consent forms and other research support information to physicians, and CRA’s for clinical activities.
• Enters clinical trial information into NCORP clinical trial access database.
• Completes pre-audit projects, assists with document preparation for cooperative group audits, and submits requested pre-audit documents to the cooperative group site staff.
• Conducts quarterly internal audits ensuring accuracy of consent version, verifies a second CRA signed off on eligibility criteria, and ensures all study updates and amendments have been discussed and properly documented in the Clinical Trials Working Group meeting minutes.
• Communicates with sponsors on specific protocol data and requested information, as needed.
• Manages the main NCORP phone line.
• Follows procedures to protect and maintain the rights and confidentiality of all human study participants.
• Participates in meetings and staff development activities.
• Performs other duties as assigned to support NCORP regulatory requirements.

Grant Administration

• Assists with organization of research related materials and data collection for grant applications for external funding
• Assists with grant reporting data search of all clinical trials and accrual data
• Responsible for all submission of check request reimbursements and invoice payment

• Knowledge of clinical trials components including informed consent; eligibility; adverse events.
• Thorough understanding of auditing processes and approval processes
• In-depth knowledge and understanding of complex audits that require interpreting regulations, guidelines, and compliance issues
• Excellent verbal, written communication, and interpersonal skills necessary to communicate with all levels of staff and a patient population composed of diverse cultures and age groups
• Demonstrate analytical and organizational, problem-solving, decision-making, critical thinking, and conflict management/resolution skills
• Ability to adhere to department policies and standards utilizing best practices
• Ability to meet deadlines
• Ability to think conceptually and work collaboratively