Research Coordinator II - MaineHealth Institute for Research

Description

Professional - Nonclinical
Req #: 71102

Summary:

This Research Coordinator II will work on a variety of projects in the Clinical Trials Office, a division of the MaineHealth Institute for Research. The successful candidate will be part of a research team and work on research projects for multiple investigators in various therapeutic areas across the MH network.

Responsiblities include:

* Identifies, screens, and interviews potential study subjects.

* Explains the project and all associated benefits/risks and obtains necessary signatures.

* Ensures the safety and protection of subjects enrolled in a research study and schedules subject assessments/visits as necessary.

* Ensures all study tests, visits, and assessments are done at appropriate time intervals.

* Assesses subjects for signs of potential adverse events and reports all suspected adverse events to the appropriate personnel/regulatory agencies.

* Completes case report forms by obtaining, compiling, and maintaining necessary documentation.

* Facilitates inspections and audits from industry personnel and regulatory agencies including internal reviews.

* Collaborates with project management team to build budgets for research activities.

* Collaborates on the design of departmental research projects and in the development of research-related data collection methods.

* Coordinates and maintains regulatory documents, including the Institutional Review Board (IRB) application, research plan, and writing the informed consent.

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

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

This position is based at our Scarborough, ME research offices. A hybrid work schedule may be available. Time may be spent in clinical settings throughout the MH network. 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.

Hiring Scam Alert

MaineHealth will never request financial information during the interview or pre-hiring process. All legitimate communications will come from an email address ending in @mainehealth.org. If you suspect fraudulent activity, please report it immediately to mhcareers@mainehealth.org.

Additional Information

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