Research Coordinator I or II - Regulatory - MaineHealth Institute for Research

Description

Professional - Nonclinical
Req #: 71045

Summary:

This position works in a dynamic and fast-paced regulatory team within the Clinical Trials Office at the MaineHealth Institute for Research, Scarborough, ME. The Regulatory Team manages the regulatory requirements of 100+ projects, from clinical trial study startup through closeout. This Clinical Research Coordinator:

* Collaborates with other members of the Clinical Trials team to conduct study related tasks.

* Coordinates and maintains regulatory documents, including the Institutional Review Board (IRB) application, research plan, and writing the informed consent under the direction of the appropriate MHIR resources.

* Communicate clinical trial updates to research teams

* Assists with facilitating inspections and audits from industry personnel and regulatory agencies, including internal reviews.

* Complies with FDA regulations and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines for conducting clinical trials.

* Participate in MHIR and CTO initiatives and teams as assigned

A fully onsite (in Scarborough, ME), hybrid, or remote work schedule is available for this position.

The MaineHealth application, a cover letter, and a resume are all required elements for application to this position.

Learn more about the MaineHealth Institute for Research in this short video!

Required Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Bachelor's Degree or equivalent combination of education and experience required.
2. License/Certifications: Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
3. Experience: Two years of clinical experience in a healthcare setting required. Meets all requirements of a Research Coordinator I.
4. Additional Skills/Requirements Required: N/A
5. Additional Skills/Requirements Preferred: N/A

Hiring Scam Alert

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If you have questions about this role, please contact sharon.nightingale@mainehealth.org