CLINICAL RESEARCH COORD ASSOCIATE

Moffitt Cancer Center

1d•$22 - $33

About The Position

The Clinical Research Coord Associate (CRC Associate) is a support position that performs duties related to data collection and/or clinical-trial coordination at Moffitt Cancer Center. The role supports assigned research protocols, generally non-therapeutic, through activities such as obtaining informed consent, collecting specimens, and entering data. It is a pre-entry position for the Clinical Trials Coordinator career path or other medical or research careers. The associate may also support therapeutic studies by entering data into database systems, following up with patients according to protocol, ordering supplies, preparing study-visit documents, assisting with regulatory-document maintenance, communicating with sponsors, and facilitating collection of study-required specimens. Work is semi-routine and performed under moderate supervision, with instructions needed for new assignments and occasional deviations from accepted practices. The role coordinates research activities and patient visits, supports regulatory and data-management functions, and helps ensure the scientific integrity of data and the rights, safety, and well-being of clinical-trial participants. The associate works with a preceptor, mentor, supervisor, or Clinical Nurse Specialist and completes required training, competencies, and continuing education.

Requirements

Associate degree required, or a high school diploma or GED plus two years of relevant experience in lieu of the degree.
Comply with institutional policies, standard operating procedures, Good Clinical Practices, and clinical-trial protocols.
Complete at least 10 relevant continuing-education contact hours during the calendar year.
Carry a pager during work hours and respond to all pages within 15 minutes.

Nice To Haves

Hands-on research experience.
One year of experience in an oncology research setting.

Responsibilities

Comply with institutional policies, standard operating procedures, guidelines, Good Clinical Practices, and clinical-trial protocols.
Coordinate activities associated with research samples or other materials and support research patient care across the Moffitt system, including notifying ancillary departments.
Maintain long-term follow-up requirements for patients previously treated on therapeutic protocols.
Conduct informed consent for assigned studies before screening, enrollment, or study-related procedures; provide participants a signed copy and document the process in the EMR.
Educate patients and families about protocol requirements.
Conduct face-to-face or telephone interviews, administer questionnaires, and request medical records for subject follow-up.
Facilitate scheduling of research visits and procedures; review schedules and ensure patients are informed and required procedures are arranged.
Prepare for protocol visits, including notifying ancillary departments, ensuring orders are scheduled, and confirming patient-completed items are available.
Meet with patients for protocol visits, remain accessible for questions or concerns, and document encounters in the EMR.
Submit patient reimbursement requests as required by study contracts and informed consent documents.
Use Florence and other applicable systems to route protocol-related procedure orders to providers for signature and timely submission to the appropriate department.
Assist with collecting study-related specimens; prepare and ship protocol samples within specified parameters and applicable IATA standards, and maintain shipping-supply inventory.
Maintain team-based tracking logs for protocol amendment training and delegation-of-authority records across the trial portfolio.
Collaborate with ancillary departments to maintain essential regulatory documents, including delegation-of-authority logs and protocol-training documentation.
Review study documents after closeout to ensure appropriate long-term storage; manage team email inboxes used for protocol-training attestations; document protocol exemptions and deviations as appropriate.
Provide team coverage, receive and return internal and external calls, triage calls appropriately, and respond to pages within 15 minutes during work hours.
Inform appropriate personnel of concerns, changes, or delays regarding patient plans; assist team members with data, accrual, screening, or coverage as assigned.
Promote teamwork and establish a congenial rapport with patients while maintaining a professional appearance and following dress-code guidelines.
Extract data from source documents and complete case report forms; assist experienced CRCs with preparing source documentation for treatment protocols.
Maintain patient and protocol data in OnCore according to SOP, including prescreening, demographics, status updates, eligibility, serious adverse events, and deviations.
Complete real-time visit certification for protocol billing compliance and participate in quality assurance, monitoring, and audits.
Communicate protocol-related issues and problems to appropriate staff or supervisors; retrieve and review medical records for data accuracy, abstraction, monitoring visits, and audits.
Attend or obtain information from at least 25% of annual staff meetings; earn at least 10 relevant continuing-education contact hours during the calendar year.
Complete an annual self-evaluation, request peer evaluations, and complete assigned peer evaluations.
Attend and actively participate in scheduled multidisciplinary tumor boards, CTO staff meetings, disease-site research meetings, and CTO role-specific meetings.
Work with a preceptor, mentor, supervisor, or Clinical Nurse Specialist and complete annual competencies and assigned assessments.