Clinical Research Compliance Coordinator II

2 weeks ago

Lebanon, New Hampshire, United States Dartmouth Health Full time

Overview

The Clinical Research Compliance Coordinator II plays a vital role in advancing the objectives of the Dartmouth Health research initiative. This position is tasked with autonomously overseeing study-related responsibilities, particularly in collaboration with Institutional Review Boards (IRBs) and research sponsors. The role involves close interaction with research teams and administrative bodies.

Key Responsibilities

Record Management: Aids in the creation, organization, and upkeep of essential documentation and records mandated by Dartmouth Health and various sponsoring entities, ensuring adherence to relevant standard operating procedures for clinical trial execution, including timely submissions to IRBs that align with sponsor and departmental expectations.

Report Development: Collects and synthesizes information concerning all relevant activities linked to the research protocol, including safety and compliance data, within established parameters.

Issue Resolution: Facilitates the resolution of regulatory and sponsor-related challenges while maintaining up-to-date knowledge to serve as a resource for the IRB and research teams on such matters.

Sponsor Communication: Engages with sponsors promptly and accurately regarding the status of ongoing research projects.

Investigator Support: Maintains a comprehensive understanding of the processes involved in investigator-initiated studies at Dartmouth Health and assists investigators, including trainees, in the submission and management of individual research project protocols and necessary approvals.

Expertise Development: Continuously enhances knowledge of departmental, IRB (both local and commercial), and institutional protocols, ensuring that clinical research endeavors comply with applicable FDA, OHRP, ICH, JC, and other regulatory standards.

Study Records Management: Oversees and tracks both on-site and off-site storage of required study documentation and performs data entry to ensure accurate tracking of essential documents.

Compliance Monitoring: Under the guidance of a supervisor, collaborates with the IRB and relevant departments to guarantee that clinical research activities adhere to FDA, OHRP, ICH, JC, and other regulatory guidelines.

Relationship Management: Assists in fostering positive and productive relationships with sponsor organizations, may facilitate site visits as necessary, and ensures that action items identified during these visits are addressed and resolved.

Document Maintenance: Effectively utilizes and maintains the system for storing and tracking essential regulatory documents in accordance with ICH Good Clinical Practice (GCP) guidelines, including but not limited to: investigators' CVs, medical licenses, CITI training, and clinical laboratory certifications.

Compliance Tracking: Utilizes relevant clinical trial management systems to review clinical trial data and provide updates to departmental leadership regarding compliance activities.

Informed Consent Development: Under the direction of a supervisor and senior regulatory team members, formulates local informed consent documents based on sponsor templates and institutional requirements, with a foundational understanding of plain language and healthcare literacy principles.

Additional Duties: Performs other responsibilities as assigned.

Qualifications

- Bachelor's degree or equivalent experience

- Minimum of 2 years of relevant research experience

- Willingness to travel as necessary

- SOCRA/ACRP Certification or eligibility for certification is preferred

Licensure/Certifications: None required

Work Environment: Hybrid remote

Area of Interest: Research/Science

Shift: Day

Dartmouth Health is committed to affirmative action and equal opportunity employment. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

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