Date Posted: Apr 6, 2021
Charlotte, NC, United States
Job ID: 4239
Job Family: Research Services
Status: Full Time
Shift Details: Regular
Department Name: 55541005040404-Institutional Review Board
Location: AH CMC Main - 1000 Blythe Blvd
As part of the Office of Clinical and Translational Research (OCTR), the IRB Program Coordinator assists with the development, improvement and management of internal operations and procedures of all IRB related research, education and financial activities ensuring that a high quality, efficient program is maintained. The Program Coordinator will assist to ensure compliance with federal, state, and institutional regulations governing the use of human subjects in research. The Program Coordinator collaborates with the Chairs of the IRB, Director IRB and Director of the Office of Clinical and Translational Research (OCTR).
Essential Functions: 50%
1. Assist in the supervision, development, coordination and quality assurance/quality control of the clinical research, education and management of IRB activities.
· Coordinate the IRB federal regulatory management of research protocols, to include but not limited to:
Ø Ensure AH IRB compliance with federal regulations as required for audit by federal and state agencies.
Ø Ensure AH compliance with International Conference on Harmonization (ICH) Good Clinical Practice Guidelines (GCP).
Ø Assist in monitoring for; receiving and distributing updated Food and Drug Administration (FDA) and National Institute of Health (NIH) regulations to Director IRB, IRB Chairs
Ø In compliance with federal regulations, revise submitted informed consents with protocol review, and assist in determining their appropriate category of review (i.e., full board, expedited review, emergency use, IRB-exempt) in conjunction with Director IRB, IRB Chairs. Request further information as needed.
Ø Assist in the oversight of other hospital departments for regulatory compliance in relation to Clinical Research.
Ø Review protocol amendments, deviations and adverse event reporting, with documentation properly maintained and in compliance with Sponsor or Sponsor Agent audit.
Ø Track and audit applications for protocol re-approvals.
Ø Assist in setting IRB agendas, attend Board meetings, and assist in taking minutes and preparing them for distribution to board members.
Ø Participate in OCTR and Research Services Administration Staff Meetings as required.
Ø Assist in developing and preparing, with Director IRB, IRB correspondence for various functions (i.e., study approvals, closures, renewal notices).
Ø Assist in developing and maintaining a clinical trial database for tracking active studies, sponsorship and IRB matrix numbers activity (i.e., new studies, re-approvals, expedited, etc.).
Ø Assist Director IRB in the implementation and maintenance of a Quality Assurance Program for Clinical Research.
· Educational Coordination
Ø Assist in instructing Investigators and Research Coordinators in IRB, FDA and NIH regulations for research involving human subjects.
Ø Assist with the review of all investigator applications for proposed research and determine the adequacy and relevancy of the information provided. Request further information as needed.
Ø Assist in coordinating and participating in a mandatory annual regulatory continuing education for board members of the three AH Institutional Review Boards.
Ø Assist in annual review/revision of IRB Policy and Procedure Manual.
· Financial Coordination
Ø Assist in assuring accurate and timely submission of IRB fees in conjunction with Research Finance.
Ø Assist in ensuring payment of IRB stipend to IRB lay members and parking permits.
Ø Ensure collection of Financial Disclosure/Conflict of Interest information for researchers.
Ø Assist in the review of financial stipulations related to research studies (i.e., patient stipends, coordinator bonuses).
2. Assist with and participate in future program development and evaluation.
3. Assist in collaborating with other Atrium Health facilities/departments for Performance Improvement purposes.
4. Provide leadership in establishing and meeting program goals.
Marginal Functions 25%
1. Perform duties such as copying, maintaining files and updating documentation of federal regulations.
2. Coordinate ordering and storage of supplies and maintain work area in appropriate condition.
3. Demonstrate high degree of communication skills through verbal and written presentation.
4. Demonstrate self-accountability for safety and health in the workplace.
5. Promote efficient job management through demonstration of time management, organization, attention to detail and prioritization skills.
6. Promote a positive attitude toward all customers.
7. Adhere to hospital policies and procedures including Standards of Excellence.
8. Perform special projects as assigned by the Director IRB
9. Perform other duties as assigned.
Works in an office environment; frequent periods of intense detail and deadlines. Must be able to manage multiple priorities. Requires long periods of sitting, operating computer keyboard and telephone. Must be
able to occasionally lift and support the weight of 15 pounds in handling equipment and supplies. Requires periodic walking around CMC main campus.
Education, Training and Experience
College degree, BS, BA or BSN preferred. Two to three years previous research and/or research regulatory experience preferred. Required knowledge of research. Requires strong scientific aptitude, medical terminology, and communication and computer skills. Must be able to concentrate for long periods of time and have perception to type matter containing terminology unique to the department. Must be proficient in typing. Personnel Management, Oral Communication Skills, Written Communication Skills, Customer Relations, Organizational Skills, Professionalism, Teamwork.