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Department: Clinical Trials Office
Schedule: Full-time 30-40 hours
Hours: 8:00AM - 4:30PM
Job ID: 37985
Job Code: 400840
Job Details:

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.

This is a grant-funded position.  Continuation of employment contingent on continued funding. 

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.



Dartmouth-Hitchcock is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, veteran status, gender identity or any other characteristic protected by law.

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