Study Coordinator

Job Description

Job Summary:

• The Study Coordinator is responsible for independently coordinating and managing multiple oncology clinical trials throughout the study lifecycle, including activation, enrollment, conduct, monitoring, and closure.
• This position works closely with Principal Investigators, research staff, sponsors, and clinical teams to ensure studies are conducted in accordance with protocol requirements, Good Clinical Practice (GCP), federal regulations, and institutional policies.

Duties and Responsibilities:

Clinical Trial Coordination:

• 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.

Participant Recruitment and Management:

• Identify, screen, recruit, and enroll eligible research participants.
• Conduct informed consent discussions and document patient participation.
• Coordinate and schedule protocol-required study visits.
• Provide participant education and study-related support.
• Monitor participant safety and communicate study requirements throughout participation.

Data Collection and Documentation:

• Maintain accurate and complete source documentation.
• Enter study data into electronic data capture systems and case report forms.
• Resolve data queries within established timelines.
• Maintain screening logs, enrollment records, and study tracking tools.
• Create and review study-specific source documents and data collection materials.
• Participate in routine monitoring visits and audits

Biospecimen and Laboratory Support:

• 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 biohazard handling and shipping procedures.

Regulatory Compliance:

• 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.
• Assist with protocol deviation reporting and corrective action plans.
• Prepare for and support study monitoring visits and audits.

Financial and Administrative Responsibilities:

• Review billing calendars and study-related financial documentation.
• Submit participant reimbursement paperwork.
• Ensure study visits are linked appropriately within the electronic medical record system.
• Track time and effort reporting as required.
• Support study-related administrative functions and reporting.

Team Collaboration:

• Serve as a primary contact for assigned clinical trials.
• Work collaboratively with investigators, sponsors, research staff, nursing teams, and clinic personnel.
• Assist in training and onboarding new staff members.
• Support development of investigator-initiated studies and study materials.
• Participate in process improvement and quality initiatives.

Minimum Qualifications:

• Bachelor’s degree in related scientific, healthcare, or research discipline and one year of relevant experience; or an equivalent combination of education and experience.
• All degrees must be obtained from accredited institutions.

Manager Preferences:

Clinical Research Expertise:

• Candidates must have 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.
• Prior involvement coordinating complex studies independently is preferred.

Regulatory and Technical Proficiency:

• Knowledge of ICH GCP, federal regulations, and clinical protocols is required, with a preference of SOCRA or ACRP certification.
• Candidates should have familiarity with medical terminology, data abstraction, and navigating medical records with high accuracy and attention to detail.

Operational and Analytical Skills:

• Possess 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.

Communication and Collaboration:

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

Work Environment:

• This position is fully onsite in Chapel Hill, NC and requires regular interaction with patients and clinical staff in healthcare and research settings.
• Exposure to bloodborne pathogens, biohazardous specimens, and other.