Note: The job is a remote job and is open to candidates in USA. Moffitt Cancer Center is hiring a Clinical Research Coordinator Associate to support clinical trial coordination and research data collection. The role supports research protocols through participant consent and follow-up, specimen coordination, regulatory documentation, and data management.
Responsibilities
- Works under moderate supervision from supervisor/mentor and can assist higher level CRCs
- Complies with Institutional policies, standard operating procedures (SOPs) and guidelines
- Adheres to Good Clinical Practices and the clinical trial protocol
- Supervisor assists with unusual or complex situations and meets 1:1 with the staff weekly or more frequently as needed
- Coordinates activities associated with research samples or other materials
- Ensures scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials
- Able to coordinate research patient care through the Moffitt system including proper notification of all ancillary departments
- Responsible for the maintenance of long term follow-up requirement for patients previously treated or therapeutic protocols
- Conducts informed consent with research participants for assigned studies ensuring informed consent is signed before subjects are screened, enrolled, or before any study related procedures are completed
- Educates patients and families on protocol requirements. Provides patient with signed copy of the informed consent and verifies the informed consent process is documented in the EMR
- Performs face-to-face or telephone interviews to administer questionnaires and/or request medical records for follow-up of subjects
- Facilitates scheduling of patient research visits and procedures consistent with protocol requirements
- Reviews the schedule of research patients to ensure all procedures are properly scheduled and the patient is aware of the schedule
- Prepares for each protocol visit including proper notifications are sent to various ancillary departments, procedure orders are correctly scheduled as well as ensuring patient completed items are available
- Meets with the patient for each protocol visit and maintains accessibility to discuss any questions/concerns regarding the study (Follow-up visits or non-treatment studies only). Documents each patient encounter in the EMR
- Administers questionnaires per protocol
- Submits patient reimbursement requests as required by the study contract and subject informed consent
- Utilizes Florence and other applicable systems to ensure protocol related procedure orders are routed to the proper provider for signature and subsequent submission to the proper department in a timely manner
- Assists in coordinating the collection of study-related specimens
- Coordinate/conduct activities associated with the preparation and shipment of protocol related samples within specified parameters and following IATA standards, as appropriate. Maintains inventory of shipping supplies
- Maintains team-based tracking logs to ensure protocol amendment trainings and delegation of authority logs are maintained properly all protocols in the trial portfolio
- Works collaboratively with various ancillary departments to maintain essential regulatory documents such as the Delegation of Authority Log and documentation of protocol training
- Reviews study documents after study close out ensuring proper long-term storage
- Management of outlook team email in-boxes utilized to collect emailed protocol training attestation
- Document protocol exemptions and deviations, as appropriate
- Provides coverage for team as appropriate
- Establish a congenial rapport with the patient
- Receives and returns phone calls from internal and external customers. Triage calls appropriately
- Displays a professional appearance and impression, adhering to dress codes guidelines
- Carries a pager during work hours and respond to all pages within 15 minutes
- Informs appropriate areas and personnel of concerns, changes, or delays regarding the patient's plan
- Provides assistance to team members as assigned by supervisor (data, accruing, screening, coverage)
- Practices and promotes teamwork within the program as well the department
- Extract data from source documents and complete case report forms for research studies as directed
- Assist more experienced CRCs with preparation of source documentation for treatment protocols
- Maintain patient/protocol data within OnCore according to SOP including but not limited to pre-screening, patient demographics, patient status updates, eligibility, SAE and deviations
- Complete real-time visit certification of patient visits for the purpose of protocol billing compliance
- Participate in ongoing quality assurance (control processes) as well as internally or externally sponsored monitoring and/or audits
- Communicate all protocol related issues/problems to the appropriate staff and/or supervisor
- Retrieves and reviews medical records for data accuracy, data abstraction, monitor visits and audits
- Attend and participate in at least 25% staff meeting per year or obtain information presented (if absent) by reviewing the minutes
- Minimum of 10 relevant continuing educational contact hours earned during the calendar year
- Complete annual self-evaluation and request peers evaluations, complete peer evaluations as assigned annually
- Attend and actively participate in regularly scheduled multidisciplinary tumor boards, CTO staff meetings, disease site program research meetings and CTO role specific meetings
- Must work with preceptor/mentor or supervisor or Clinical Nurse Specialist
- Completes annual competencies and passes related assessments as assigned by CTO leadership
Skills
- Associates degree required, in lieu of Associates degree 2 years of relevant experience with a high school diploma or GED
- Hands on research experience preferred with one year experience in the oncology research setting
Benefits
- Hybrid (Part -time in Office)
Company Overview
Company H1B Sponsorship