IRB Administrator

Essential Duties:  

Ø       Maintain and promote positive working relationships with clients by providing timely and professional service to their needs within the scope of company mission and accompanying regulations.

Ø       Review any information received from clients and follow up in order to ensure data capture.

Ø       Work toward 100% accuracy in their work and understand the importance of accurate information as it pertains to strict confidentiality standards of the company.

Ø       Act as the liaison between the IRB Board, CROs, and sponsors with study related information.

Ø       Ensure clients have all information they need regarding the new submission of their study including handling inquiries and providing timely follow up.

Ø       Review new study applications and ensure they are complete and accurate according to internal standards.

Ø       Stay abreast of changes in regulations and company wide processes so as to be a reliable resource to clients in the new study phase.

Ø       Ensure the thorough transition of reviewed studies to the Project Management team communicating special cases and the needs of each study.

Ø       Work as a team with fellow co-workers to ensure all project team efforts are completed according to company policies and procedures and all departmental goals and objectives are achieved.

Ø       Enter new study information into Access Data Base.

Ø       Prepare IRB agendas and prepare/distribute agenda items for IRB review.

Ø       Attend IRB meetings and take notes on new study discussions.

Ø       Prepare minutes for new studies from Board Meeting. Circulate minutes to “Primary Reviewers� from the board for their acceptance.  Compile minutes for distribution at IRB meeting.

Ø       Modify sponsors’ Informed Consent Document templates according to CGIRB standard wording. After Board Meeting, modify ICF with Board’s changes and send to sponsor/CRO for their acceptance.

Ø       Generate approvals and letters as needed.

Ø       Provide excellent customer service to all staff and/or board members for project related inquiries and/or needs.

Ø       Maximize relationships with clients and communicate potential leads to the Business Development team.

Ø       Coordinate changes in studies, documents, and/or contact info entering changes accurately into access data base and communicating changes to necessary departments in the company.