Study Coordinator II / Madison, WI (On-Site)

***Must have at least 1 year of experience working within a clinical research role***

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.