Remote position but will require travel to the site at least quarterly and as needed

Conducts required clinical trial quality assurance activities critical to ensuring participant safety, and compliance with federal regulations, institutional policies, and Institutional Review Board requirements. Determines and reports research protocol, regulatory and investigational product accountability compliance adherence.

1. Develops monitoring plans to comply with ICH Good Clinical Practice for DH Sponsor-Investigator clinical trials – particularly focusing on Investigational New Drug / Investigational Device Exemption protocols
2. Supports DH Sponsor-Investigators in the study activation process, supporting the development of critical operational components, including put not limited to: quality assurance activities, protocol, consent, database, and manual of operating procedures
3. Monitors subject records, regulatory, and product accountability documentation for compliance with ICH Good Clinical Practice, federal regulations and guidelines, Dartmouth Health policies, and applicable IRB requirements
4. Performs audits and quality assurance assessments according to the research portfolio risk assessment
5. Categorizes findings and determines when noncompliance requires immediate remedial
6. Generates detailed reports noting the status of the study
7. Proposes recommendations for corrective actions and evaluates corrective action plan follow up and improvement
8. Analyzes trends in clinical trial regulatory and data
9. Identifies and proposes training and continuing education needed by DH clinical research status to be current and maintain the standards of ICH Good Clinical Practice, federal regulations and guidelines, Dartmouth policies, and DH Standard Operating Procedures (SOPs)
10. Provides senior management team detailed critical compliance reports of findings and proposed corrective plans, trend analysis, and policy and training

• Bachelor’s degree, preferably in Health Sciences, with 3 years of experience in clinical trials research support, preferably as a research coordinator or the equivalent in education and experience
• Experience with industry sponsored, federally sponsored and investigator-initiated clinical
• Knowledge of GCPs and federal regulations related to human subject research, especially research using investigational new
• Experience with medical coding and electronic medical record systems
• Independent decision maker with proven communication skills, particularly regarding sensitive
• Good technical writing
• Strong organizational skills with meticulous attention to
• Demonstrated experience with a wide range of computer applications

• Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) or obtained certification within the first year of hire.