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

Fortrea; Madison (WI); On-site; USD 45,000 - 75,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(K)

Paid time off

Employee recognition awards

ERGs

Job summary

Fortrea in Madison, WI is seeking a Study Coordinator II to work with healthy volunteer participants and learn to read clinical research protocols in a fast-paced, team-oriented setting. This office/clinic-based role supports senior team members and contributes to protocol execution across various study types.

The position requires 1–2 years of clinical research experience, a life-science degree or allied health certification, and knowledge of GCP/ICH.

Qualifications

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution.
• 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.

Responsibilities

• Responsible for practical/administrative activities in support of a clinical research trial.
• Supports and assists senior study team members such as the Clinical Research Coordinator and Project Manager.
• Logistical set up of study to ensure good study flow and adequate resources.
• Assists Clinical Research Coordinator with responsibilities and acts as back-up as needed.
• Creation of source documents, labels, and study specific instructions.
• Creation of study schedules; orders supplies/equipment and dietary needs.
• Liaises with CRU contracted services; assists with staff training of study procedures.
• Coordinates tasks related to participant check in and discharge; may assist with resolution of participant issues.
• Maintains records and understands FDA, GCP and ICH requirements.
• Attends required meetings; communicates with team; maintains quality of work.

Skills

Life science knowledge

2 years related experience

1-2 years clinical research experience

Computer skills

GCP knowledge

Education

Bachelor's degree in life science, pharmacy or related subject

Certification in allied health profession

Tools

Microsoft Word

Microsoft Excel

Job description

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.