Conducts required clinical trial monitoring and auditing reviews critical to assuring patient safety in compliance with federal regulations and institutional policies.
Determines and reports any non-compliance with research protocol and applicable internal and external regulations to the Leadership in Office of Research Operations (ORO).
Responsibilities:
1. Develops monitoring materials and documentation to comply with and implement the Clinical Trials internal monitoring policy.
2. Monitors data and regulatory documentation for compliance with ICH Good Clinical Practice, FDA regulations and guidelines, Dartmouth policies, and the DH Standard Operating Procedures (SOPs).
3. Reviews and evaluates Case Report Forms (CRFs) from various EDC platforms.
4. Verifies Serious Adverse Event/Unanticipated Adverse Device Effects (SAE/UADE) reporting for compliance with sponsor, FDA and IRB reporting requirements.
5. Generates detailed reports noting the status of the study compliance.
6. Categorizes findings and determines when findings require immediate Corrective and preventive Action Plans (CAPA).
7. Proposes recommendations for CAPA.
8. Evaluates CAPA’s progress and resolution.
9. Analyzes trends in clinical trial regulatory and data compliance.
10. Identifies and develops updates and revisions to the ORO Monitoring and Safety Director and develop/revise the internal monitoring policies and SOPs.
11. Identifies and proposes training and continuing education needed by DHH clinical research faculty and staff to be current and maintain the standards of ICH Good Clinical Practice, FDA regulations and guidelines, Dartmouth policies, and DHH HRPP Standard Operating Procedures (SOPs).
12. Provides senior management team detailed critical compliance reports of findings and proposed corrective plans, trend analysis, and policy and training proposals.
13. Performs other duties as required or assigned.
Minimum Qualifications:
· Bachelor’s degree, preferably in Health Sciences (Nursing, Pharmacy), with 3 years of experience in clinical trials research support, preferably as a research coordinator or equivalent in education and experience required.
· Professional certification with SOCRA or ACRP is preferred.
· Experience with industry sponsored, federally sponsored and investigator initiated clinical research.
· Knowledge of GCP and FDA regulations related to human subject research, especially research using investigational new drugs.
· Experience with medical coding and electronic medical record systems preferred.
· Independent decision maker with proven communication skills, particularly regarding sensitive information.
· Good technical writing skills and communication skills.
· Strong organizational skills with meticulous attention to detail.
· Experience with EDC, CTMS and Office suite is desired.
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