Clinical Research Coordinator

**This position requires an onsite presence and will not be open to any candidates that are looking to relocate**

Position Summary

The Clinical Research Study Coordinator will independently coordinate and manage multiple oncology clinical trials throughout the full study lifecycle, including study startup, activation, participant enrollment, study conduct, monitoring, and closeout.

This position works closely with Principal Investigators, research staff, sponsors, clinical personnel, and study participants to ensure clinical trials are conducted according to study protocols, Good Clinical Practice (GCP), FDA and federal regulations, Institutional Review Board (IRB) requirements, and applicable institutional policies.

The role requires direct patient interaction and coordination of research activities across medical center, campus, and affiliated clinical locations in the Chapel Hill area.

Compensation: $32.50 per hour

Position Type: Contract

Assignment Length: 6 Months

Essential Responsibilities

• Independently manage multiple oncology clinical trials from study startup through closeout.
• Develop and maintain a thorough understanding of assigned study protocols and sponsor requirements.
• Coordinate study activation, implementation, ongoing conduct, monitoring, and closure activities.
• Participate in site initiation visits, startup meetings, monitoring visits, and closeout visits.
• Maintain complete and accurate study documentation and regulatory records.
• Coordinate complex clinical research studies involving investigational drugs and/or medical devices.
• Identify, screen, recruit, and enroll eligible clinical research participants.
• Conduct informed consent discussions and appropriately document participant consent and study participation.
• Coordinate and schedule protocol-required study visits and procedures.
• Educate participants regarding study requirements, expectations, and procedures.
• Provide ongoing study-related support throughout participant involvement.
• Monitor participant safety and ensure study requirements are communicated throughout participation.
• Maintain accurate, complete, and timely source documentation.
• Enter clinical trial data into electronic data capture (EDC) systems and case report forms (CRFs).
• Review data for accuracy and 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.
• Navigate electronic medical records to obtain and document study-related information.
• Participate in routine monitoring visits and audits.
• Coordinate the collection, processing, storage, and shipment of research specimens.
• Maintain accurate specimen accountability and tracking documentation.
• Collaborate with investigators and laboratory personnel regarding specimen analysis and protocol requirements.
• Ensure compliance with applicable biohazard handling, storage, and shipping procedures.
• International Council for Harmonisation Good Clinical Practice (ICH-GCP)
• FDA and federal clinical research regulations
• Institutional Review Board (IRB) requirements
• Study sponsor requirements
• Applicable institutional policies and procedures
• Collect and report adverse events (AEs) and serious adverse events (SAEs) within required timelines.
• Assist with identifying and reporting protocol deviations.
• Support development and implementation of corrective action plans when necessary.
• Prepare for and support sponsor monitoring visits, regulatory reviews, and audits.
• Maintain study readiness and ensure required documentation is current and complete.
• Review study billing calendars and related financial documentation.
• Submit participant reimbursement documentation.
• Ensure study visits are appropriately linked and documented within the electronic medical record.
• Complete required time and effort reporting.
• Support study-related administrative functions, tracking, and reporting.
• Serve as a primary point of contact for assigned clinical trials.
• Collaborate with Principal Investigators, sponsors, research staff, nursing personnel, clinical teams, laboratory personnel, and study participants.
• Assist with training and onboarding new research staff.
• Support the development of investigator-initiated studies and related study materials.
• Participate in process improvement and quality initiatives.

Minimum Qualifications

• Bachelor's degree in a related scientific, healthcare, research, or similar discipline and at least one year of relevant paid professional experience; or
• An equivalent combination of education and relevant paid experience.
• Degrees must be obtained from accredited institutions.

Preferred Qualifications and Experience

Ideal candidates will have:

• Oncology clinical research experience as a Clinical Research Coordinator, Study Coordinator, Clinical Research Specialist, or similar role.
• Experience with Phase I, Phase II, and/or Phase III clinical trials.
• Experience working with investigational drugs and/or medical devices.
• Translational clinical research experience.
• Demonstrated ability to independently manage multiple clinical trials from startup through closeout.
• Knowledge of ICH-GCP, FDA regulations, federal research requirements, and clinical research protocols.
• Experience with patient identification, screening, recruitment, informed consent, enrollment, and protocol-required study visits.
• Experience with source documentation, data abstraction, EDC systems, CRFs, and electronic medical records such as Epic.
• Experience supporting monitoring visits and regulatory or sponsor audits.
• Experience documenting and reporting protocol deviations, adverse events, and serious adverse events.
• Familiarity with biospecimen collection, processing, tracking, storage, and shipment.
• Strong knowledge of medical terminology.
• SOCRA or ACRP certification is preferred.
• Previous clinical research experience within an academic medical center, cancer center, hospital, or site-level research environment is preferred.

Skills and Competencies

• Strong organizational and project-management skills with the ability to manage multiple studies and competing priorities.
• Excellent attention to detail, particularly when gathering, documenting, and reviewing clinical research data.
• Strong analytical, decision-making, and problem-solving abilities.
• Strong computer and clinical research systems proficiency.
• Excellent written and verbal communication skills.
• Ability to communicate effectively with investigators, sponsors, clinical personnel, research participants, and cross-functional teams.
• Collaborative, patient-focused, and service-oriented approach.
• Ability to work independently while contributing effectively within a multidisciplinary research environment.

** This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**