Clinical Research Coordinator

About the role

The Department of Surgery and Perioperative Care seeks a Clinical Research Coordinator to manage day-to-day study operations under the direction of a Principal Investigator (PI). This role will work effectively with faculty PIs to ensure successful participation in key mission-aligned research studies.

Responsibilities

• Coordinates study start-up and feasibility
• Conducts pre-study feasibility and assists with budget/coverage analysis inputs and study calendars
• Prepares start-up packages, facilitates site-initiation, and implements IRB-approved protocols/SOPs
• Collaborates with pharmacy, lab, and radiology to establish workflows and order sets
• Recruits, screens, and consents participants
• Plans and conducts study visits
• Maintains investigational product (IP) accountability and coordinates shipments per sponsor SOPs
• Ensures participant safety and reporting
• Manages regulatory and ethics documentation
• Supports onsite/remote monitoring and audits
• Coordinates site operations and stakeholder communication
• Supports study budgets and research billing workflows with appropriate routing
• Facilitates study close-out
• Performs other duties as required

Requirements

• Bachelor’s degree in health, life science, or related field; or equivalent combination of education and directly related clinical research experience
• 3 years of clinical research coordination or closely related human-subjects research experience (screening/consent, visit coordination, data entry, IRB submissions)
• Ability to work comfortably in a clinical environment, including the operating room

Qualifications

• Master’s in Nursing, Allied Health, Public Health, Biology, Pharmacology, or related field preferred
• 1-2 years coordinating interventional trials (oncology, cardiology, neurology, or surgical), including specimen handling, IP accountability, and monitoring support
• Phlebotomy and ECG competencies; experience with EDC/CTMS and Epic research modules

Skills

• Deep, hands-on expertise in ICH-GCP, IRB/HIPAA, EDC/CTMS, and protocol conduct
• Operates EDC/CTMS/EPIC research modules with high data accuracy
• Applies ICH-GCP and FDA/IRB guidance to consent and AE reporting decisions
• Breaks work into actionable steps; anticipates dependencies and resources
• Sequences start-up tasks (regulatory, training, order sets) to hit FPI dates
• Buffers time for monitoring, query resolution, and safety updates

Benefits

Not specified

Pay

$53,464 + depending on qualifications

Schedule

Standard office equipment; repetitive use of a keyboard