Clinical Study Manager Jobs in Jenison, MI (NOW HIRING)

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The Clinical Research Nurse - Start Up plays a vital role in the early phases of clinical trial implementation. Works in collaboration with the principal investigator, regulatory and operational teams, and other research staff to support pre-activation activities that enable successful trial launch. This includes assisting with protocol feasibility, document preparation, workflow development, and cross-team coordination necessary to ensure study readiness.
Utilizes clinical expertise to identify and resolve protocol operational gaps, ensures compliance with internal standards and external regulations, and supports efficient and ethical study implementation. Contributes to training tools, supports IRB submissions, and helps transition newly activated trials to the appropriate clinical team.

Duties and Responsibilities, including but not limited to:

• Coordinate pre-activation processes including feasibility assessments, sponsor communications, and study start-up documentation.

• Serve as the nursing representative during site qualification, pre-study visits, and startup calls with sponsors and CROs.

• Develop protocol-specific source documentation, workflows, and readiness checklists in collaboration with operations staff, and participate in quality control efforts to ensure startup documentation accuracy and procedural compliance.

• Coordinate with regulatory, pharmacy, laboratory, and IT teams to align resource needs and ensure protocol compatibility.

• Facilitate IRB documentation preparation and support regulatory submissions.

• Evaluate trial protocols to identify operational gaps and propose mitigation strategies.

• Ensure a seamless handoff of the trial to the clinical research nurse and patient-facing team post-activation.

• Maintain clear and complete documentation of the startup process in CTMS and trial management platforms.

• Train research staff and volunteers, as necessary.

• Perform other responsibilities as assigned in line with research strategy and mission.

Basic Qualifications:

• Associate's degree in nursing required

• 2 years of RN experience in a healthcare setting required

• 1 year of relevant experience in clinical research required

• Licensed RN in the state of Michigan required upon hire

• Basic Life Support (BLS) - AHA or ARC, required upon hire

Preferred Qualifications:

• Bachelor's degree in nursing preferred

• Experience in oncology, nuclear medicine, and/or radiology nursing preferred

• Experience in both oncology and research preferred

• OCN preferred

• SOCRA or ACRP certification preferred

Schedule Details:

• Employment Status: Full time (1.0 FTE)

• Weekly Scheduled Hours: 40

• Hours of work: 8:00 a.m. and 4:30 p.m.

• Days worked: Monday-Friday with some flexibility. This position may require occasional travel. A hybrid work opportunity is available after the introductory period, with the option to work remotely 1-2 days per week.

At BAMF Health, our top priority is patient care. To ensure we are able to drive a Bold Advance Medical Future, we offer a well-rounded benefit package to care for our team members and their families. Highlights include:

• Employer paid High Deductible Health Plan with employer HSA contribution

• Flexible Vacation Time

• 401(k) Retirement Plan with generous employer match

• Several benefit options including, but not limited to; dental, vision, disability, life, supplemental coverages, legal and identity protection

BAMF Health provides equal opportunities to all employees for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

BAMF Health will reasonably accommodate qualified individuals with a disability so that they can perform the essential functions of a job unless doing so causes a direct threat to these individuals or others in the workplace and the threat cannot be eliminated by reasonable accommodation or if the accommodation creates an undue hardship to BAMF Health.

BAMF Health is an Equal Opportunity Employer and will not accept or tolerate discrimination or harassment against any applicant, employee, intern, or volunteer based uponthe following characteristics: race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability or handicap, sexual orientation, gender identity/expression, transgender status, genetic information, pregnancy or pregnancy-related status, marital status, veteran status, military service, any application for any military service, or any other category or class protected by applicable federal, state, or local laws.