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

Role Summary

Study Coordinator II, Madison, WI (On-Site) – office/clinic-based role supporting clinical research trials and interacting with healthy volunteer participants within a fast-paced, team-oriented environment.

Responsibilities

• 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.
• 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 SOPs and authors additions/revisions.
• Train and instruct less experienced staff.
• Performs other related duties as assigned.
• And all other duties as needed or assigned.

Qualifications

• 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‚Äô 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‚Äôs 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.

Skills

• Strong organization and attention to detail.
• Ability to work in a fast-paced, changing environment with tight timelines.
• Teamwork and effective communication skills.
• Technology-based data capture and management.

Education

• As listed in Qualifications above.

Additional Requirements

• Physical requirements: ability to work in an upright/static position 6-8 hours per day; repetitive hand movements; occasional crouching and bending; ability to lift 15-20 lbs; regular attendance; varied hours may be required.