Posted: February 17, 2012

The Administrative Coordinator is responsible for maintaining GuideStar processes to ensure effective and efficient regulatory processing workflows that support all IRB processing, regulatory document collection and provision to sponsors, and reporting on all pending and active trials conducted at GuideStar Sites. The primary focus of the position is proper filing and reporting to achieve and maintain compliance with internal policy and external sponsor and federal regulations pertinent to research involving human subjects.

1. Responsible for managing systems to track all IRB processes such as annual continuing review due tracking and provision of documents required by sponsors on an annual basis.

2. Responsible for updating existing procedures on a continuing basis and providing input on new procedures as required.

3. Remain abreast of Federal Regulations governing human subject research and incorporate into day-to-day regulatory processes, as well as act as the liaison with external regulatory agencies.

4. Facilitates relationships and processes initial IRB applications for all new trials conducted through GuideStar with multiple site and commercial IRBs.

5. Responsible for all subsequent IRB processes to include protocol amendments, annual continuing reviews, and accurately and timely report on and off-site adverse events.

6. Collaborate with Site Operation Managers in the preparation of informed consent forms. Conduct and coordinate the preparation and submission of Informed Consent Form documents in compliance with the regulatory requirements of Federal, State, and local agencies governing biomedical research.
7. Processing, submission, and proper reporting and filing of regulatory documents required by sponsors throughout the course of a study from initiation through to closure.

8. Upload and ensure most up-to-date, compliant version of study documents and tools to include protocols, amendments, and informed consents for access by site personnel to the GuideStar document management center.

9. Direct sponsor contact for protocol document related activities, and responsible for timely communication to areas of impact such as Research Finance and Site Operations and follow up on any task that need to be executed as a result of amended protocol documents

10. Establish and maintain all regulatory project files – hard and electronic.

11. Responsible for tracking all activities and generating a bi-weekly Pending Project listing clearly delineating completed vs. outstanding items and tasks in the protocol activation process.

12. Responsible for ensuring all approvals and requirements have been met prior to patient enrollment

13. Verifies that all required forms have been submitted and all reviews (scientific, ethical, financial, and operational) have been completed and sponsor initiation site visits have taken place prior to project activation.

14. Assist Site Managers with coordinating, scheduling, communicating, and documenting external sponsor visits with appropriate personnel. Provides and facilitate regulatory record review for monitor visits and audits.

Qualifications

A. Bachelor’s Degree or equivalent education and experience in regulatory processing for clinical research. Minimum 2-4 years experience in a progressively responsible position in research.

B. Understanding of clinical research operations, familiarity with IRB processing and regulatory document gathering and submissions.