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University Of Michigan - Ann Arbor, MI
posted 2 months ago
About the position
The Clinical Research Coordinator Associate position at Michigan Medicine involves coordinating multiple clinical research studies, ranging from moderate to complex. The role requires a high level of independence, expertise in clinical research, and the ability to make informed decisions. The coordinator will work closely with research participants, manage data, and ensure compliance with regulatory standards while contributing to the advancement of medical research.
Responsibilities
- Conduct and oversee clinical trials in allergy.
- Recruit subjects and maintain accurate source documentation and electronic data entry.
- Work on regulatory aspects with sponsors, local and central IRBs, and the CTSU.
- Monitor patients after receiving investigational products.
- Assist with industry-sponsored clinical trials and NIH-funded studies, including recruitment and retention of subjects, scheduling procedures, obtaining informed consent, and data collection.
- Communicate with patients to set up appointments and document interactions electronically.
- Perform study-specific tests in clinic or designated research spaces.
- Design workflow and develop quality assurance processes for study startup and execution.
- Maintain accurate research records and transcribe collected data onto study documents and electronic databases.
- Assist with identification and documentation of adverse events according to standard operating procedures and protocol requirements.
- Review billing calendars and reconcile research billing, payments, and invoices with department grant managers.
- Ensure compliance with protocols, good clinical practice guidelines, and all federal, local, and University regulations.
Requirements
- Bachelor's degree in Health Science or equivalent experience.
- Certification as a Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) required by 01/01/24.
- Minimum 2 years of directly related experience in clinical research and clinical trials.
- Previous experience with subject recruitment and retention, and coordination of NIH studies or clinical trials (minimum 3 years).
- Ability to work independently or as part of a team.
- Certification of Good Clinical Practice Training required.
- Understanding of Medical Terminology.
- Exceptional organizational and computer skills in Microsoft applications.
- Ability to work with minimal supervision and collaborate effectively with diverse teams.
- Demonstrated problem-solving and conflict resolution skills.
- Ability to multi-task and meet deadlines.
- Excellent interpersonal, oral, and written communication skills.
Nice-to-haves
- 4+ years of direct related experience in clinical research.
- Experience with REDCAP or similar clinical research databases.
- Bachelor's degree in Health Science or equivalent experience (for CRC Technician).
- Experience in a large complex health care setting (for CRC Technician).
- Previous experience with spirometry testing and/or sputum induction (for CRC Assistant).
- Clinical experience with respiratory patients (for CRC Assistant).
- Certification through ACRP or SOCRA (for CRC Assistant).
Benefits
- Excellent medical, dental, and vision coverage effective on the first day.
- 2:1 match on retirement savings.
