Clinical Research Program Manager
- 1860 Shawano Ave
- Full Time Prevea Health
- 3.
2 Green Bay, WI Job Details Full-time 6 hours ago Qualifications Staff supervision Team supervision Maintaining patient confidentiality HIPAA Process improvement Employee relationship building Project management experience in healthcare Conflict management Managing clinical research teams Desktop applications Computer skills Productivity software Clinical quality assurance standards Research and development project management Cross-functional communication Full Job Description This position will work 40 hours per week and is benefit eligible. Clinical Research Manager Come work where we specialize in you! We have nearly 2,000 reasons for you to consider a career with Prevea Health—they're our employees. We're an organization that values kindness, responsibility, inclusivity, wellness and inspiration. At Prevea, we provide continuous education, training and support so every member of the team contributes to our success. Together we are the best place to get care and the best place to give care. Job Summary The Clinical Research Program Manager leads the day-to-day operations and strategic direction of the Clinical Research Program and provides direct supervision to clinical research staff (up to three direct reports). Under the direction of the Executive Director, the Manager coordinates and oversees research study-specific clinical and regulatory activities across multiple study protocols of different therapeutic areas and phases, in accordance with applicable GCP/ICH regulations, Standard Operating Procedures (SOPs), and study-specific protocols and processes. The Manager oversees the conduct of clinical research trials — including patient identification and eligibility, the informed consent process, case report form documentation, and the identification and reporting of adverse events to the FDA, IRB, and/or study sponsor as applicable — and ensures the site and principal investigators remain compliant with approved protocols. The Manager serves as the primary point of contact for research-related questions and activities, acts as a liaison among patients, families, healthcare professionals, and sponsors, sets program priorities, and drives the quality, growth, and sustainability of clinical research at Prevea Health. What you will do Leads and directs the day-to-day operations and strategic direction of the Clinical Research Program — including goal setting, operational priorities, and business development — and serves as the primary point of contact and subject matter resource for all clinical research activities at Prevea Health, in collaboration with internal departments and external partners, including HSHS. Negotiates research study budgets in partnership with sponsors, investigators, and internal stakeholders, and oversees related financial processes, including budget reconciliation, payment collection, and tracking. Ensures regulatory compliance by collaborating with the HSHS Institutional Review Board (IRB) and other external IRBs, and by developing, implementing, and maintaining research Standard Operating Procedures (SOPs) and ensuring staff adherence. Provides direct supervision to clinical research staff (up to three direct reports), including setting clear goals and performance expectations, tracking progress, coaching and mentoring, and supporting professional growth and engagement. Facilitates Investigator-Initiated Studies (IIS) and supports approval processes for student research projects, including coordination, documentation, and regulatory support. Assists the legal team with research contract review and negotiation to support timely study initiation. Education Qualifications Bachelor's Degree In a science or healthcare-related field, or a degree in nursing Required Master's Degree In a related discipline (e.g., clinical research, public health, healthcare administration). Preferred Experience Qualifications 3-5 years leadership or supervisory experience, preferably in a healthcare setting. Required 3-5 years experience working in a healthcare clinical research setting. Required Skills and Abilities Capable of leading the implementation of process changes. Excellent interpersonal skills and behaviors. Ability to form professional relationships with patients, peers, and leadership. Ability to prioritize work and meet changing demands. Ability to handle and process confidential information. Skilled in problem-solving techniques. Fosters teamwork through effective written and verbal communication. Ability to manage teams and conflict effectively. Demonstrated project management skills, with the ability to drive multiple projects to successful completion within tight timeframes and strict deadlines. Maintains current knowledge and application of Good Clinical Practice (GCP) standards and HIPAA regulations in the conduct of clinical trials. Demonstrates critical thinking and initiative to independently manage complex projects and multiple priorities. Proficient with computer applications (e.g., Word, Excel, Adobe) and able to navigate databases and online data repositories. Maintains current and working knowledge of the clinical discipline(s) related to the research scope. Licenses and Certifications Holds or is eligible for and obtains Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) certification. Maintains ACRP or SOCRA certification in good standing once obtained. within 180 Days Required Successfully completes Human Subject Protection and Good Clinical Practice (GCP) training through the Collaborative Institutional Training Initiative (CITI). within 30 Days Required Physical Demands Sit
- Constantly Stand
- Rarely Walk
- Rarely Drive
- Rarely Climb (Stairs/Ladders)
- Rarely Bend (Neck)
- Occasionally Bend (Waist)
- Rarely Squat
- Rarely Twist/Turn (Neck)
- Frequently Twist/Turn(Waist)
- Occasionally Lift/Carry 0-10 lbs.
- Rarely Lift/Carry 11-25 lbs.
- Rarely Lift/Carry 26-35 lbs.
- Rarely Lift/Carry 36-50 lbs.
- Rarely Push/Pull up to 10 lbs.
- Occasionally Push/Pull 11-25 lbs.
- Occasionally Push/Pull 26-35 lbs.
- Occasionally Push/Pull 36-50 lbs.
- Occasionally Push/Pull 51-75 lbs.
- Occasionally Push/Pull 76-100 lbs.
- Rarely Reach (Above shoulder level)
- Occasionally Reach (Below shoulder level)
- Occasionally Simple Grasping (Hands/Arms)
- Constantly Fine Manipulation (Hands/Arms)
- Constantly Gross Manipulation (Hands/Arms)
- Frequently Working Conditions Noise
- Occasionally Travel Requirements 5% Hearing Requirements Hears Whispers < 3 feet
- Constantly Hears Whispers 3-8 feet
- Constantly Vision Requirements Color Discrimination
- Constantly Near Vision (Correctable to Jaeger 2 or 20/40 binocular)
- Constantly Distance Vision (Correctable to Snellen chart 20/40 binocular)
- Constantly Prevea is an Equal Employment Opportunity/Affirmative Action employer.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United State and to complete the required employment eligibility document form upon hire. Prevea participates in E-verify. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify
