Study Coordinator 2 Madison Wi

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 **Study Coordinator II,** to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment. Each day is different, you will be exposed 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. WHAT YOU WILL DO: Responsible for practical/administrative activities in support of a clinical research trial. The Operations Coordinator II supports and assists the senior study team members such as the Clinical Research Coordinator and Project Manager as appropriate. **Other key responsibilities**: * Responsible for logistical set up of study to ensure good study flow and adequate resources are assigned. * Assists the Clinical Research Coordinator with their responsibilities and acts as their back-up as needed. * Assists and/or is responsible for the creation of source documents, labels, and study specific instructions. * Assists and/or is responsible for creation of study schedules. Orders supplies/equipment and dietary needs for assigned studies. * Liaises with CRU contracted services, such as clinical labs and ECG services. Assists and/or is responsible for staff training of study specific procedures. * Coordinates tasks related to participant check in and discharge and may assist with resolution of participant issues. * Is present in the clinical work areas for critical events or as assigned by a senior team member. * Completes sample shipment documentation as necessary. May assist with sample shipments as needed. * Compiles data tables/summaries as requested. * Assists with on-time CRF completion and query process as appropriate. * Assists with the compilation of protocol and SOP deviations. * Provide logistical feasibility for protocol development. * Attends all required meetings as appropriate. * Maintains skills to perform study tasks and assists with study procedures as necessary. * Maintains accurate records of all work undertaken. * Maintains an understanding of FDA, GCP and ICH requirements. * Maintains constant awareness of participant safety and dignity at all times. * Ensures that client and participant confidentiality is maintained. * Responds to team queries in a timely manner. * Takes ownership for the quality and standard of own work. * Evaluates current SOP’s and authors additions/revisions. * Train and instruct less experienced staff. * Performs other related duties as assigned. * And all other duties as needed or assigned. **YOU NEED TO BRING…** * University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). * In lieu of a degree, typically 2 years’ experience in related fields (e.g., pharmaceutical, laboratory, data analysis) will be considered in addition to the experience requirement. * 1-2 years of professional work experience with at least one year’s experience in clinical research. * Basic knowledge of computers and programs (e.g., Microsoft Word, Excel). * Knowledge of drug development process, ICH Guidelines and GCP. * Basic Life Support Skills (BLS) or CPR/AED Certified. The important thing for us is you are comfortable working in an environment that is: * **Fast paced**: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. * **Changing priorities constantly** asking you to prioritize and adapt on the spot. * **Teamwork** and **people skills** are essential for the study to run smoothly. * **Technology based**. We collect our data directly into an electronic environment. What do you get? * 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, Vision, Life, STD/LTD (multiple insurance carriers) * 401(K) * Paid time off (PTO) * Employee recognition awards * Multiple ERG’s (employee resource groups) **_Physical Requirements:_** * _Ability to work in an upright and /or stationary position for 6-8 hours per day._ * _Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment._ * _Occasional crouching, stooping, with frequent bending and twisting of upper body and neck._ * _Ability to access and use a variety of computer software developed both in-house and off-the-shelf._ * _Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs._ * _Regular and consistent attendance._ * _Varied hours may be required._ Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).