Clinical Research Coordinator
Location: Madison, Wisconsin (On-Site)
Job Type: Full-Time
Job Requisition ID: 262923
About the Role
We are seeking a highly motivated Clinical Research Coordinator (CRC) to support the operational conduct of Phase I clinical trials at our Madison, WI research unit. This role provides direct interaction with healthy volunteer participants while coordinating study activities and ensuring compliance with study protocols, regulatory requirements, and company SOPs.
As a CRC, you will work alongside Project Managers, Principal Investigators, and cross-functional clinical teams to ensure studies are executed safely, efficiently, and according to established timelines.
Note: This position is not eligible for visa sponsorship.
Key Responsibilities
Study Setup & Planning (40%)
Coordinate all study start-up activities.
Develop and obtain approvals for study-specific documentation.
Create study schedules and clinical procedure plans.
Ensure laboratories, equipment, and operational resources are prepared.
Collaborate with Operations and Pharmacy teams to support efficient study execution.
Study Coordination (30%)
Manage critical study events including:
Participant Check-In
PK (Pharmacokinetic) Days
Participant Check-Out
Monitor participant safety, compliance, and well-being.
Escalate operational issues and implement corrective actions.
Coordinate medical consultations and treatment when required.
Communicate participant status and adverse events to investigators and project teams.
Study Meetings (20%)
Facilitate and participate in key study meetings, including:
Clinical Start-Up Meetings
Clinical Planning Meetings
Site Initiation Meetings
Contribute operational insights and study execution recommendations.
Protocol Review (10%)
Review study protocols and provide site-level feedback.
Evaluate protocol feasibility, safety considerations, logistics, and site capabilities.
Support distribution and implementation of protocol amendments.
Additional Responsibilities
Participant Management
Verify participant eligibility during screening and pre-dose assessments.
Address participant concerns and complaints professionally.
Authorize participant stipend payments when required.
Clinical Trial Operations
Maintain study master files and site documentation.
Support electronic Trial Master File (eTMF) management.
Manage biological sample shipment schedules.
Coordinate monitoring visits and resolve monitoring queries.
Ensure accurate source documentation and timely data entry.
Quality & Compliance
Ensure adherence to:
ICH-GCP Guidelines
Study Protocols
Regulatory Requirements
Company SOPs
Document and communicate protocol deviations and unscheduled events.
Support client audits, inspections, and continuous quality improvement initiatives.
Training & Leadership
Deliver and facilitate study-specific training sessions.
Mentor junior coordinators and operational staff as needed.
Develop clinical skills and perform study procedures when required.
Recruitment Support
Collaborate with recruitment teams to ensure enrollment goals are achieved.
Monitor recruitment progress and provide regular updates to project management.
Client Interaction
Support client visits and conference calls.
Understand client expectations and maintain high-quality service delivery.
Participate in client audits and answer study-related operational questions.
Qualifications
Required
Bachelor's degree in:
Life Sciences
Pharmacy
Nursing
Medical Laboratory Technology
Related Healthcare Field
OR
Minimum 3 years of relevant experience in lieu of a degree.
Experience
1–2 years of hands-on experience as a Clinical Research Coordinator (CRC) or similar clinical research role.
Experience supporting clinical trials in a regulated environment.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Brussels |Antwerp :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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