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

Overview 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 interact directly with healthy volunteer participants while learning to read clinical research protocols and working in a fast-paced team 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 is a full-time, office/clinic-based job in Madison, WI . If you join us, you will work with some of the world’s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug. Coordinators can directly impact patient care through close face-to-face interactions with participants while practicing clinical skills and staying current with the latest medical technologies and treatments. When the drug you worked with gets approved, you will touch many patients’ lives around the world. What You Will Do Overall accountability for the operational conduct of assigned studies, working with the Project Manager, Principal Investigator and operational staff to ensure studies conform to regulatory and protocol requirements and SOPs while maintaining safety and integrity. Act as the primary site contact for the PM, communicate potential issues, and assist in taking appropriate action to meet or exceed 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 – Perform all aspects of the setup process, including development and approval of study-specific documents, study schedules and clinical procedure planning. Coordination – Manage critical events (check-in, PK days, check-out), resolve/escalate issues identified by staff and participants, monitor participant safety and compliance, and provide adverse event updates to investigators and the PM. Study Meetings – Facilitate/attend and contribute to key study planning meetings (Clinical Start Up, Clinical Planning, Site Initiation). Protocol Review – Review protocols, consolidate site comments for the PM or Medical Writer, considering logistics, safety and site capabilities. May distribute final protocols and amendments to the site. Study Planning – Ensure laboratory, equipment and operational resources are in place; coordinate with Operations and Pharmacy to ensure efficient dosing and timely documentation. Complaints – Handle participant complaints efficiently to maintain customer satisfaction. Clients – Be aware of client expectations, facilitate client visits and calls with PM/site management assistance, and participate in client/process audits by addressing study conduct questions. Training – Deliver and facilitate study-specific training. Clinical Skills – Learn and develop clinical skills to perform study tasks and procedures as needed. Participant Eligibility – Verify eligibility at Panel Selection and Pre-dose, communicating with investigators and the PM regarding study participant eligibility. Documentation – Maintain the study master file and ensure site documents are available for uploading to the eTMF. Shipping – Create/manage study-specific shipping calendar and ensure biological samples are shipped as directed by the client in a timely manner. Data Monitoring – Facilitate/coordinate monitoring visits and address site comments/queries. Quality – Ensure protocol deviations and unscheduled events are properly documented and communicated. Audit Readiness – Work with site management to close issues from CQIs and client audits, implementing new processes where needed. Recruitment – Collaborate with Recruitment/Screening to define a recruiting plan and keep the PM updated on progress. Pharmacy Collaboration – Coordinate inventory receipt, accountability and disposal of trial materials with pharmacy staff. Source Documentation – Assist with on-time source document completion and query resolution. Stipends – Authorize study participant stipend payments as required. Other – All other duties as needed or assigned. YOU NEED TO BRING… University/college degree desirable (life science, pharmacy or related subject preferred) or certification in a related allied health profession (e.g., nursing certification, medical or laboratory technology) from an accredited institution. In lieu of a degree, typically 3 years’ related experience will be considered. 1-2 years of hands-on experience supporting clinical trials in a Clinical Research Coordinator (CRC) capacity. Knowledge of protocol designs, study objectives and procedures; knowledge of the 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, changing-priority, team-oriented environment with technology-based data capture. The important thing for us is you are comfortable working in an environment that is: Fast-paced: deviations from the study protocol are not allowed and meeting timelines is critical. Changing priorities and need to adapt quickly. Teamwork and people skills are essential for study success. Technology-based data capture is used. What do you get? Benefits Medical, Dental, Vision, Life, STD/LTD 401(K) PTO Employee recognition awards Multiple ERGs (employee resource groups) Physical Requirements Ability to work in an upright/ stationary position for 6-8 hours per day. Repetitive hand movements to operate lab equipment. Occasional crouching and frequent bending/twisting of upper body. Proficiency with computer software. Light to moderate lifting up to 15-20 lbs. Regular and consistent attendance; varied hours may be required. Learn more about our EEO & Accommodations request here. #J-18808-Ljbffr