Clinical Research Coordinator / Madison, WI (On-Site)

About the role

We are seeking a Clinical Research Coordinator to join our dynamic team in Madison, WI. This role offers opportunities to work with leading pharmaceutical, biotechnology, and medical device companies in early phase clinical trials.

Responsibilities

• Overall accountability for the operational conduct of assigned studies
• Study Set-up – Develops and approves study-specific documents, schedules, and clinical procedures
• Clinical Coordination – Coordinates critical events, monitors participant safety, and provides updates
• Study Meetings – Facilitates and attends key study planning meetings
• Protocol Review – Reviews and consolidates comments from the clinical site on draft study protocols
• Study Planning – Works with the site to ensure operational requirements are fulfilled and resources are adequately resourced
• Complaints – Handles participant complaints efficiently and effectively
• Clients – Facilitates client visits and participates in audits
• Training – Delivers/facilitates study-specific training
• Participant Eligibility – Verifies eligibility for study participation and communicates with investigators and PM
• Data Monitoring – Facilitates and coordinates monitoring visits and resolves queries
• Quality – Ensures proper documentation and communication of protocol deviations and unscheduled events

Requirements

• University/college degree desirable in life science, pharmacy, or related subject
• Typically 3 years’ experience in a related field or 1-2 years of hands-on experience supporting clinical trials
• Knowledge of protocol designs, study objectives, and procedures
• Experience in a Clinical Research Coordinator (CRC) capacity
• Previous customer service experience desirable
• Previous experience coordinating people or processes desirable

Qualifications

• Ability to work in a fast-paced environment with strict adherence to study protocols
• Strong teamwork and interpersonal skills
• Comfortable working in a technology-based environment

Skills

• Knowledge of drug development process and ICH guidelines
• Experience with electronic data capture systems
• Effective communication and problem-solving skills

Benefits

• Medical, Dental, Vision, Life, STD/LTD insurance
• 401(K)
• Paid time off (PTO)
• Employee recognition awards
• Multiple employee resource groups (ERGs)

Physical Requirements

• Ability to work in an upright and/or stationary position for 6-8 hours per day
• Repetitive hand movement with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Occasional crouching, stooping, bending, twisting of upper body and neck
• Light to moderate lifting and carrying (maximum lift of 15-20 lbs)
• Varied hours may be required