Clinical Research Coordinator II - Psychiatry

Summary

The Medical College of Wisconsin is looking for an experienced, full-time Clinical Research Coordinator II for the National Institutes of Health-funded SOLO Study which is a clinical trial of screening interventions to increase detection of anal cancer. The individual hired for this position will be responsible for coordinating research activities at multiple sites in conjunction with the principal investigator and other team members.

Some of the coordination of research activities will occur in Milwaukee; thus, knowledge of Milwaukee and its diverse communities is preferred. This position requires substantial capacity to travel, and to work effectively within a research team and with external research collaborators. Occasionally, there may be travel to Chicago and Houston to support research activities there. The position may also recruit, train, supervise staff and manage study budgets.

The successful candidate must have excellent communication skills, strong time-management skills, and the ability to use good judgment in daily tasks.

These skills and experience will be needed to implement approved study protocols with high fidelity to ensure completion of study accrual and retention goals while collecting high-quality data in clinics and community settings. Specific responsibilities will include working with SOLO team members to ensure successful recruitment of research participants, conducting screening and enrollment activities while working with a tight study timeline, administering clinical protocols, ensuring high participant retention, monitoring the well‑being of research participants, reporting on accrual and retention, helping identify and solve problems to ensure study goals are met, helping prepare reports for study meetings and regulatory requirements, doing basic analysis of data, and completing administrative tasks.

• Prepare documents to assure compliance with Institutional Review Board and other regulatory agency requirements.
• Ensure successful creation and disbursement of recruitment material and advertisements for trial participants. Recruit, screen, consent and enroll program participants.
• Recruit Community Advisory Board members and maintain board.
• Conduct the activities of the study clinics.
• Collect both quantitative and qualitative research data. Report study‑related data and progress to management, study investigators and sponsor as required.
• Support participants with appointments and maintain contact with participants to meet protocol‑driven timelines. Monitor the study related activities on a participant and protocol level.
• Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators and study team.
• Support participants with appointments and maintain contact with participants to meet protocol‑driven timelines. Monitor the study related activities on a participant and protocol level.
• Work with team members to develop, implement and maintain comprehensive research databases.
• Oversee the development of study materials including websites, forms, and reports.
• Work with study biostatistician, data analyst, and data manager to prepare study data for publication.
• Work with the principal investigator on creation of manuscripts for the peer‑reviewed literature.
• Work closely with principal investigator to manage study resources.
• Organize internal and external meetings, site visits, and special events specific to the study.
• Assist in recruitment, training and scheduling of study team volunteer staff.
• Work collaboratively with other institutions and medical clinics.
• Evaluate and write research protocols in collaboration with the study investigator.
• Participate in writing and responding to funding opportunities.

Knowledge of clinical trial design, documentation, and records management.

Excellent oral and written communication skills are essential. Strong critical thinking, problem solving and attentiveness to detail required. Strong computer skills. Knowledge of clinical research study principles including appreciation for protocol adherence and human subject research ethics. Competency with communities at increased risk for HIV infection.

Appropriate experience may be substituted for education on an equivalent basis.

Minimum Required

Education:

Bachelor's Degree

Minimum

Required Experience:

2 years

Preferred Education: Master of Science, Master of Public Health, Master of Arts

Preferred Experience: 5 years of experience in research program coordination. Experience with program management in a medical research or educational environment preferred. Prior work with clinical research preferred.

Field: Science - epidemiology, public health, biostatistics, human biology, nursing, etc.

Certification: CITI training within 90 days of hire. Certified Clinical Research Professional preferred and required within 6 months of employment.

Work requires…