Under general direction, the Research Monitoring Specialist will conduct internal monitoring reviews of the IRB approved human subject research protocols per Research Institute guidelines. The Research Monitoring Specialist will provide documentation of and report on monitoring visit results and final outcomes of reviews. Responsibilities will also include ongoing development of internal research monitoring procedures and processes as well as provide general support to the IRB Research Coordinator.
Essential Job Duties:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Schedule and conduct routine, for cause, or other post-IRB approval monitoring visits
2. Establish procedures for conducting monitoring reviews and assist with development of monitoring documentation
3. Prepare written reports of visits results and retain documentation of monitoring on global share drive
4. Meet with principal investigators and research study staff to review research records and follow-up with principal investigator and study staff on monitoring results as necessary
5. Develop and participate in monitoring/auditing educational activities to improve research compliance
6. Prepare and assist in preparation of corrective action plans for cases of non-compliance during monitoring visits
7. Assist Clinical Research Coordinators and Research Nurse’s with routine, sponsor-led, on site study monitoring visits
8. Assist Research Institute staff and leadership with preparation for routine or for-cause FDA and NCI audits
9. Assist in maintenance of principal and sub-investigator research training and credentialing.
10. Support functions of AAMC Clinical Research Committee and other regulatory duties as assigned.
The minimum level of education and experience for this position includes:
- BA/BS in medical, health sciences, or other appropriate discipline required
- Experience with quality assurance and/or good clinical practice monitoring required
- Certification by a professional organization in the area of human subjects research and knowledge of federal human subjects research regulations and good clinical practice is preferred
Working Conditions, Equipment, Physical Demands:
There is reasonable expectation that employees in this position will not be exposed to blood-borne pathogens.
Physical Demands –
The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.
The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as deemed necessary.