Position Description:
Purpose: Coordinate the day-to-day administrative and regulatory activities of clinical research trial programs for various grants, registry projects, and other studies that may be assigned including expanded access programs and the Division's various patient sample clinical trials. Provide support to the team to facilitate the achievement of the program's goals
Primary Functions
- Recruit, screen, enroll and obtain consent from program participants. Conduct or coordinate training for program participants.
- Coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants.
- Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.
- Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators.
- Assure compliance with all relevant IRB and other regulatory agency requirements.
- Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
- Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
- Work with Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program.
- Maintain program timeline including tracking deadlines for program components.
- Coordinate program outreach activities including acting as a liaison with community organizations.
Knowledge - Skills - Abilities
- Experience in research or study coordination and/or compliance. Knowledgeable of federal, state, local and other regulatory requirements that involve clinical trials or grants.
- Strong interpersonal and facilitation skills to work effectively with stakeholders from multiple organizations, to include leading meetings, and coordinating study activities.
- Proficient in appropriate software and technology required to fulfill clinical trial and grant requirements.
- Has good judgment and analytical ability to problem solve and make decisions, formulate reports, perform statistical analysis and interpret data, create and monitor work plans, prioritize workload, and meet deadlines.
- Customer focused, organized. builds trust, and has strong communication, critical thinking, and influencing skills.
Preferred Schedule:
Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate business needs.
Position Requirements:
Specifications Appropriate experience may be substituted on equivalent basis
Minimum Required Education: Associate's Degree in relevant field
Minimum Required Experience: 1 year experience in research program coordination. With 2-3 years' experience in program coordination in a medical research or educational environment preferred. Prior work with clinical research or patient care preferred.
Certification: CITI training required within 90 days of hire. CCRP or CCRC preferred
#LI-NI1
MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination
The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering a diverse community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.
.