Clinical Research Coordinator I

About the role

Perform the day-to-day administrative activities of the clinical research trials program. Provide support to the team to facilitate the achievement of the program’s goals.

Responsibilities

• Working with multiple Principal Investigators ensure proper conduct of assigned Clinical Trials Office trials, Children’s Hospital of Wisconsin.
• Maintain regular contact and provide updates whenever necessary.
• Work closely with CTO leads/managers on a day-to-day basis providing updates and managing priorities.
• Screen, recruit, enroll and obtain consent from study 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 study data. Report data and progress to PIs and CTSI 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, HIPAA, GCP and other regulatory requirements.
• Responsible for maintaining ongoing training, certifications and compliance with current regulations at MCW, CHW and VA.
• Assist in the preparation of IRB documents and reports.
• Assist in the evaluation and writing of research protocols.
• Collaborate on the development of study 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.
• Process and ship lab specimens as necessary. IATA certification to be obtained within 30 days of hire.
• Familiarity with EMR (EPIC) preferred.
• Display familiarity in utilization of clinical trial management systems, proficiency with OnCore preferred.

Skills

• Knowledge of biology, chemistry, mathematics, documentation, and records management.
• Data utilization, complex problem solving, critical thinking, resource management, and writing skills.

Qualifications

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

• Minimum Required Education: Associate's Degree
• Minimum Required Experience: 1 year
• Required Certification/Licensure(s): CITI and GCP training within 90 days of hire

Physical Requirements

Work requires occasionally lifting moderate weight materials, standing, or walking continuously.

Work Environment

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.

Sensory Acuity

Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.

Benefits

• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• Paid Parental Leave
• Employee & Family Assistance Program (EFAP)
• Pet Insurance
• On campus Fitness Facility, offering onsite classes
• Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.