Research Coordinator II - Institute Research

Description

Maine Health Institute for Research

Professional - Nonclinical
Req #: 83566

This Research Coordinator II will work on a variety of projects in the Clinical Trials Office, a division of the Maine Health 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.

• 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.

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.

• Education:
  
  Bachelor's degree or equivalent combination of education and experience required.
• License/
  
  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.

We offer benefits that support an individual's needs for today and flexibility to plan for tomorrow - programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family.

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