CLINICAL RESEARCH NURSE / COLLEGE OF MEDICINE

About the Role

This position combines clinical and regulatory responsibilities in a clinical research setting. Clinical duties include assisting with the development and implementation of clinical research trials, pre-screening patients for study eligibility, and performing delegated study tasks such as treatment procedures, blood draws, EKGs, administration of study medication/devices, recording adverse events, and ensuring ethical and legal compliance. The role may serve as the primary contact with study monitors, develop operational plans, and maintain awareness of all study activities.

Regulatory responsibilities involve ensuring compliance with federal, state, and local laws related to human research, preparing and maintaining regulatory documentation, and presenting studies to the Institutional Review Board (IRB) or other departments. The position may also conduct study-specific training for research and ancillary staff. Travel may be required between clinical sites in the Saginaw/Tri-Cities area.

Responsibilities

• Act as a liaison between hospital physicians and the principal investigator (PI).
• Collaborate with investigators, sub-investigators, referring physicians, patients and families, research sponsors, and ancillary staff.
• Network at sponsored research events as a representative for the Covenant Healthcare College of Medicine at Central Michigan University.
• Facilitate and execute study protocol requirements in a team environment.
• Acquire and maintain training and certifications for delegated research procedures.
• Follow state and federal regulations, protocol requirements, and Good Clinical Practice Guidelines.
• Provide training for new employees, ancillary departments, and volunteers.
• Develop and collaborate with research sponsors for upcoming studies.
• Recruit study patients, establish patient/coordinator relationships, and address patient needs with the PI.
• Coordinate all aspects of research study requirements, including feasibility assessments, site qualification visits, and initiation visits.
• Perform study-specific duties such as completing case report forms, tracking patient visits, processing sponsor reports, and resolving queries.
• Train study patients under the direction of the PI and assess patients for trial eligibility based on inclusion/exclusion criteria.
• Conduct study visits as per protocol, reporting safety deviations promptly to sponsors and regulatory bodies.
• Document study procedures in source worksheets or databases and prepare documentation for sponsors/PIs.
• Create, update, and maintain regulatory documents, ensuring contact with sponsors regarding regulatory issues.
• Complete adverse event reporting, prepare for monitor visits, and assist with internal/external audits.
• Maintain supply inventory, reorder supplies, and inspect new research materials.
• Perform quality control activities and maintain accurate records of investigational medications/devices.
• Administer study medications/devices in compliance with Michigan State, local, and federal laws.
• Oversee laboratory set-up, monitor study supplies, and manage the dissolution process for studies.
• Collect, process, and ship biological samples (e.g., blood, stool, sputum) as required by protocol.
• Develop and maintain IATA Training for shipping lab samples and study materials.
• Prepare and present new project proposals, annual reviews, and interim study documents for IRB submission, including informed consent forms, abstracts, and communications.
• Complete visit billing documentation and collaborate with the Finance Department for monthly reports.
• Review patient billing and resolve disputes or adjustments with relevant departments.
• Develop and review invoices for services related to internal and external research studies.
• Perform other duties as delegated and assigned.

Requirements

• Associate's degree from an accredited school of nursing with passage of an RN licensure exam.
• Current registration with the State of Michigan Board of Nursing as a Registered Nurse (RN).
• One year of nursing experience related to the duties of the position.
• Certificate of completion for CITI training or willingness to obtain certification upon hire.
• Strong interpersonal and communication skills.
• Ability to analyze and interpret data and maintain confidentiality.

Preferred Qualifications

• Bachelor's degree in nursing.
• BLS certification.
• Experience conducting single/multicenter clinical trials, human subject research, or similar activities.

Benefits

CMU employees enjoy access to a nationally recognized wellness program along with health care and benefits that exceed regional, state, and national norms.

Pay

$70,000 - $90,000 per year.

Schedule

• Full-time, 1.0 FTE.
• 12-month position.
• Weekly schedule: Monday-Friday, 8:00 a.m. - 5:00 p.m., with weekends and evenings as needed.

Location

Saginaw, MI.