Clinical Research Coordinator​/Madison, WI; On-Site

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US. We are currently seeking a Clinical Research Coordinator to work directly with healthy volunteer participants while learning to read clinical research protocols in a fast‑paced, team‑oriented environment. The role is performed full‑time, office/clinic‑based in Madison, WI, and involves interacting with leading pharmaceutical, biotechnology and medical device companies during Phase1 studies.

This position is not eligible for sponsorship.

• Overall accountability for the operational conduct of assigned studies, working closely with the Project Manager, Principal Investigator and operational staff to ensure regulatory and protocol compliance and maintain study safety and integrity.
• Primary site contact for the Project Manager, communicating potential issues, taking appropriate actions and ensuring client requirements and timelines are met or exceeded.
• Responsible for Study Set‑Up (40%) – development and approval of study documents, schedules and clinical procedure planning.
• Coordination (30%) – running critical events, resolving/escalating issues identified by staff and participants, monitoring participant safety and providing adverse event updates to investigators and the Project Manager.
• Study Meetings (20%) – facilitation and attendance of key meetings such as Clinical Start‑Up, Planning and Site Initiation.
• Protocol Review (10%) – reviewing protocols, consolidating comments from the site and distributing final protocols and amendments.
• Study planning – ensuring laboratory, equipment and operational requirements are fulfilled and that dosing runs efficiently; coordinating all documentation within timely limits.
• Client relations – meeting client expectations, facilitating visits, attending client calls, and participating in client and process audits.
• Training – delivering and facilitating study‑specific training, learning and performing clinical tasks as required.
• Participant eligibility – verifying eligibility for panel selection and pre‑dose, and communicating with investigators and PM.
• Maintaining the site master file and managing the shipping calendar for biological samples.
• Data monitoring – coordinating monitoring visits and resolving comments/queries raised during site visits.
• Quality – documenting protocol deviations, unscheduled events, and working with QA to address CQI issues and implement process improvements.
• Recruitment – defining a recruiting plan with Recruitment/Screening, ensuring timely study recruitment and reporting progress to the Project Manager.
• Pharmacy coordination – awareness of receipt inventory, accountability, and disposal of clinical trial materials.
• Supporting on‑time source document completion and query processing.
• Authorizing study participant stipend payments as required.
• All other duties as needed or assigned.

• University/college degree desirable (life science, pharmacy or related subject preferred) or certification in a related allied health profession from an accredited institution.
• In lieu of a degree, typically 3years’ experience in a related field will be considered; 1–2years of hands‑on experience supporting clinical trials in a CRC capacity is acceptable.
• Knowledge of protocol designs, study objectives and procedures; drug development process, ICH guidelines and GCP.
• Previous customer service experience desirable.
• Previous experience coordinating people or processes desirable.
• Comfortable working in a fast‑paced, technology‑based environment with frequent changes in priorities and strong teamwork skills.
• Technical proficiency with computer software developed both in‑house and off‑the‑shelf.

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers), 401(K).
• Paid time off (PTO).
• Employee recognition awards.
• Multiple Employee Resource Groups (ERGs).

• Ability to work upright and/or stationary for 6–8hours per day.
• Repetitive hand movements, quick finger, hand and wrist motions to operate lab equipment.
• Occasional crouching, stooping, bending and twisting of the upper body and neck.
• Ability to lift and carry objects, including luggage and a laptop computer, with a maximum lift of 15–20lbs.
• Regular and consistent attendance; varied hours may be required.

Learn more about our EEO & Accommodations request here.