Institutional Review Board Coordinator

Overview:

The Institutional Review Board (IRB) Coordinator plays a crucial role in ensuring that research involving human subjects is conducted ethically and in compliance with regulatory requirements. The IRB Coordinator serves as a liaison between researchers, the IRB committee, and regulatory bodies, facilitating the review process and ensuring that all necessary documentation is complete and accurate.

Responsibilities:

• Manage the submission and review process for research protocols involving human subjects. Coordinate with researchers to ensure that all required documentation is submitted in a timely manner.

• Interpret and apply federal, state, and institutional regulations governing research involving human subjects. Ensure that research protocols comply with ethical standards and regulatory requirements.

• Review submitted research protocols for completeness and accuracy. Identify any potential issues or areas of concern that may require further review by the IRB committee.

• Coordinate meeting schedules for the IRB committee. Prepare meeting agendas, review materials, and other necessary documents. Provide administrative support during meetings, including taking minutes and documenting decisions.

• Serve as the primary point of contact for researchers submitting protocols for review. Provide guidance and assistance to researchers throughout the review process. Address any questions or concerns related to IRB policies and procedures.

• Maintain accurate records of all IRB activities, including protocol submissions, review decisions, and correspondence with researchers. Ensure that all documentation is stored securely and in compliance with regulatory requirements.

• Track the status of approved research protocols and ensure that ongoing research activities remain in compliance with approved protocols. Conduct periodic reviews and audits as needed.

• Develop and deliver training sessions and educational materials on IRB policies, procedures, and ethical principles. Ensure that researchers and staff members are aware of their responsibilities regarding human subjects research.

• Responsible to develop and implement IRB policies according to institutional policy or SOPs.

• Stay informed about changes to regulations and guidelines related to human subjects research. Participate in professional development activities to enhance knowledge and skills in research ethics and regulatory compliance.

Qualifications:

• Bachelor's degree (16 years of qualification) in a biology, public health, development studies, social sciences, ethics or any other relevant field.

• Candidate must have ICH-GCP certification.

• Two year of experience in a research and academic environment that demonstrates experience with compliance issues and familiarity with research ethics and methods.

• Strong knowledge of National as well as federal regulations (e.g., Common Rule, HIPAA, FDA, and DRAP) and ethical principles governing research involving human subjects.

• Proficiency with Microsoft Office and other relevant software applications.

• Commitment to maintaining confidentiality and upholding ethical standards in all aspects of the job.

Job Type: Contract
Contract length: 12 months

Work Location: In person