Research Compliance Associate II

Overview

The Research Compliance Associate ll (RCAll), at a skilled level, conducts required clinical trial monitoring and auditing reviews critical to assuring patient safety incompliance with federal regulations and institutional policies. Determines and reports any non-compliance with research protocols and applicable internal and external regulations to the study team and Leadership in Office of Research Operations (ORO), as necessary.

Responsibilities

Guides new Research Compliance Associate l staff on Good Clinical Practice (GCP), Human Subjects Protection (HSP) practices, the ethical conduct of research and a full range of monitoring and auditing responsibilities including confirming regulatory compliance.

Develops monitoring materials and documentation to comply with and implement the Clinical Trials internal monitoring process, with limited oversight by the Research Quality and Safety Director or designee.

Monitors data and regulatory documentation for compliance with ICH Good Clinical Practice, FDA regulations and guidelines, Dartmouth Health policies, and the DH Standard Operating Procedures (SOPs).

Reviews and evaluates Case Report Forms (CRFs) from various EDC

Verifies that Serious Adverse Event/Unanticipated Adverse Device Effects (SAE/UADE) have been reported and are in compliance with sponsor, FDA and IRB reporting requirements.

Generates detailed reports noting the status of the study compliance, with limited oversight from the Research Quality and Safety Director or designee.

Categorizes findings and determines when findings require immediate Corrective and preventive Action Plans (CAPA), proposes recommendations for CAPA and evaluates CAPA’s progress and resolution.

Compiles and summarizes trends in clinical trial regulatory and data compliance and reports summaries to Research Quality and Safety

Identifies and develops updates and revisions to the ORO Monitoring Plan and works with the Research Quality and Safety Director to develop/revise the internal monitoring policies and

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 SOPs with guidance from the Research Quality and Safety Director or designee.

Provides Research Quality and Safety Director detailed critical compliance reports of findings and in collaboration with the Research Quality and Safety Director or designee proposes corrective plans, trend analysis, and policy and training proposals.

Assists internal and external stakeholders with Part 11 regulatory systems, including training, oversight and validation, as necessary.

Performs other duties as required or assigned

Qualifications

• Bachelor's degree, Masters preferred, preferably in Health Sciences (Biology, Psychology, Nursing, Pharmacy), with 2 years of experience as a Clinical Research Associate/Monitor/Auditor in clinical trials research or 4 year equivalent experience required.
• Certificate of Completion for a Clinical Research Monitor course offered by an accredited organization (SOCRA, ACRP, etc.) 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 and investigational devices.
• Experience with medical coding and electronic medical record systems
• 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 required

Required Licensure/Certifications

• Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred.
• Certificate of Completion for a Clinical Research Monitor course offered by an accredited organization (SOCRA, ACRP, etc.) required
• Human Subject Protection, Responsible Conduct of Research and Good Clinical Practice certificates required within 30 days of hire.