Research Coordinator II - MaineHealth Institute for Research

Responsibilities

• 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.
• Affirms 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.
• Captures 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.

Requirements

• Education: Bachelor's degree or equivalent combination of education and experience required.
• Licenses/Certifications: Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
• Experience: Two years of clinical experience in a healthcare setting required. Meets all requirements of a Research Coordinator I.

Qualifications

Meets all requirements of a Research Coordinator I.

Skills

N/A

Benefits

N/A

Pay

N/A

Schedule

N/A

About the Role

The 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.