Research Compliance Associate (FT), NCCC Administration

📁
Research/Science
📅
180001T6 Requisition #

Position Summary:


Conducts required clinical trial quality and investigational

pharmacy reviews critical to assuring patient safety,

compliance with federal regulations and institutional policies.

Determines and reports research protocol, regulatory and

investigational pharmacy compliance adherence.


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, federal

regulations and guidelines, Dartmouth policies, and the DH

Standard Operating Procedures (SOPs).

3. Reviews and evaluates Case Report Forms (CRFs).

4. Verifies Serious Adverse Event/Unanticipated Adverse

Device Effects (SAE/UADE) reporting for compliance with

sponsor, FDA and IRB reporting requirements.

5. Categorizes findings and determines when findings

require immediate remedial action.

6. Generates detailed reports noting the status of the study

compliance.

7. Proposes recommendations for corrective actions.8. Evaluates corrective action plan follow up and

improvement progress.

9. Analyzes trends in clinical trial regulatory and data

compliance.

10. Identifies and develops updates and revisions to the CTO

and OCR internal monitoring policy and SOPs.

11. Identifies and proposes training and continuing education

needed by DH clinical research staff to be current and

maintain the standards of ICH Good Clinical Practice, federal

regulations and guidelines, Dartmouth policies, and DH

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, with 3 years of experience in clinical trials research support, preferably as a research coordinator or the equivalent in education and experience required.
  • Professional certification as a clinical research coordinator preferred.
  • Experience with industry sponsored, federally sponsored and investigator initiated clinical research.
  • Knowledge of GCPs and federal 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.
  • Strong organizational skills with meticulous attention to detail.
  • Demonstrated experience with a wide range of computer applications desired.

 

 

 

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