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

About the Role

We are seeking a Clinical Research Coordinator to interact directly with healthy volunteer participants while learning to read clinical research protocols in a fast-paced, team-oriented environment. Each day is different, exposing you to a wide variety of therapeutic indications and study types (ascending dose, first-in-human, food effect, drug-to-drug interactions, etc.). This full-time, office/clinic-based position in Madison, WI offers the opportunity to work with leading pharmaceutical, biotechnology, and medical device companies during a vital stage of clinical development: establishing the safety, tolerability, and pharmacokinetics of new drugs.

As a Coordinator, you will maintain a close face-to-face relationship with participants while practicing clinical skills and knowledge, engaging with the latest medical technologies and treatments. Your work will directly impact patient care globally when the drugs you help develop receive approval.

Responsibilities

• Overall accountability for the operational conduct of assigned studies, ensuring compliance with regulatory and protocol requirements, standard operating procedures, and participant safety and integrity.
• Serve as the primary site contact for the Project Manager (PM), communicating potential issues and assisting in appropriate actions to meet client requirements and timelines.
• Independently undertake routine studies and more complex studies with guidance; may coach and mentor Operations Coordinators and junior staff.
• Study Set-up (40%): Develop and approve study-specific documents, study schedules, and clinical procedure planning.
• Coordination (30%): Coordinate critical events (e.g., check-in, PK days, check-out), resolve/escalate issues, monitor participant safety and compliance, and provide updates on participant well-being to investigators and PM.
• Study Meetings (20%): Facilitate/attend and contribute to key study planning meetings (e.g., Clinical Start-Up, Clinical Planning, Site Initiation).
• Protocol Review (10%): Review protocols, provide consolidated site comments to the PM or Medical Writer, and distribute final protocols/amendments.
• Proactively ensure laboratory, equipment, and operational requirements are fulfilled; collaborate with Operations and Pharmacy for efficient dosing and documentation.
• Handle participant complaints efficiently to maintain customer satisfaction.
• Facilitate client visits, attend client calls, and participate in audits covering study conduct questions.
• Deliver/facilitate study-specific training and perform clinical procedures as necessary.
• Verify participant eligibility for panel selection and pre-dose, communicating with investigators and PM.
• Oversee maintenance of the study master file and ensure site documents are uploaded to the eTMF.
• Create/manage study-specific shipping calendars for timely biological sample shipments.
• Facilitate/coordinate monitoring visits and resolve data queries.
• Ensure protocol deviations and unscheduled events are documented and communicated.
• Work with site management to address issues from CQIs and client audits, implementing new processes as needed.
• Collaborate with Recruitment/Screening to define recruiting plans and update the PM on progress.
• Consult with pharmacy staff on clinical trial material receipt, inventory, accountability, and disposal.
• Assist with source document completion and query resolution.
• Authorize study participant stipend payments as required.
• Perform all other duties as assigned.

Requirements

• University/college degree desirable (life science, pharmacy, or related subject preferred) or certification in a related allied health profession (e.g., nursing, medical, or laboratory technology).
• In lieu of a degree, typically 3 years of experience in a related field will be considered.
• Minimum 3-4 years of experience in a research environment.
• Knowledge of protocol designs, study objectives, and study procedures.
• Understanding of the drug development process, ICH guidelines, and GCP.
• Previous customer service experience is desirable.
• Experience coordinating people or processes is desirable.

The ideal candidate is comfortable working in an environment that is:

• Fast-paced: No deviations from study protocols are allowed, and timelines must be strictly adhered to.
• Dynamic: Priorities change constantly, requiring adaptability and on-the-spot decision-making.
• Team-oriented: Strong teamwork and people skills are essential for smooth study operations.
• Technology-driven: Data is collected directly into an electronic environment.

Benefits

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits, including but not limited to:

• Medical, dental, and vision insurance (multiple carriers available).
• Life, short-term disability (STD), and long-term disability (LTD) insurance.
• 401(K) retirement plan.
• Paid time off (PTO).
• Employee recognition awards.
• Multiple Employee Resource Groups (ERGs).