Study Coordinator

Responsibilities

• Independently manage multiple oncology clinical trials from startup through study closeout.
• Maintain a comprehensive understanding of assigned study protocols and sponsor requirements.
• Coordinate study activation, implementation, monitoring, and closure activities.
• Participate in site initiation visits, startup meetings, monitoring visits, and closeout visits.
• Maintain study documentation and regulatory records.
• Identify, screen, recruit, and enroll eligible research participants.
• Conduct informed consent discussions and document patient participation.
• Clock study visits and schedule protocol-required study visits.
• Provide participant education and study-related support.
• Monitor participant safety and communicate study requirements throughout participation.
• Coordinate collection, processing, storage, and shipment of research specimens.
• Maintain specimen accountability and tracking documentation.
• Collaborate with investigators and laboratory personnel regarding specimen analysis and study requirements.
• Ensure compliance with: Good Clinical Practice (GCP), FDA and Federal Research Regulations, Institutional Review Board (IRB) Requirements, Sponsor Requirements, Client Policies and Procedures.
• Report serious adverse events within required timelines.
• Aid in protocol deviation reporting and corrective action plans.
• Prepare for and support study monitoring visits and audits.
• Review billing calendars and study-related financial documentation.
• Submit participant reimbursement paperwork.
• Track time and effort reporting as required.
• Support study-related administrative functions and reporting.
• Serve as a primary contact for assigned clinical trials.
• Work collaboratively with investigators, sponsors, research staff, nursing teams, and clinic personnel.
• Aid in training and onboarding new staff members.
• Support development of investigator-initiated studies and study materials.
• Participate in process improvement and quality initiatives.

Qualifications

Prior experience as a study coordinator or in oncology clinical trials, with strong preference for those familiar with Phase I-III clinical research to include investigation drugs and devices, as well as translational trial experience.

Strong computer skills, the ability to manage multiple projects, and demonstrated decision-making and problem-solving capabilities.

High attention to detail in data gathering and documentation or procedures is critical.

Effective verbal and written communication skills are necessary, along with a customer-oriented mindset and the ability to work collaboratively in a team environment.

Benefits

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

Pay

TBD

Schedule

TBD