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
- General Office Environment or Home-Based.
- Must be able to sit at a computer for long periods of time.
- Must be able to use hands to finger, handle or touch objects, tools, or controls, including a computer keyboard, for up to 8 hours per day.
- Will involve out of normal office hours as required by the role.
- Travel is primarily to USA/UK/EUROPE up to 10% of the time, with up to 80% of that time requiring an overnight stay.
- Ability to drive and have a valid driver’s license as appropriate per country travel norms.
Learn more about our EEO & Accommodations request here [https://careers.fortrea.com/us/en/eeo-and-accommodations].
