CLINICAL RESEARCH COORD ASSOCIATE

Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer.

As the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, Moffitt employs some of the best and brightest minds from around the world. Join a dedicated team of nearly 11,000 who are shaping the future we envision. Moffitt has been recognized as a Best and Brightest Company to Work For in the Nation and is continually named one of the Tampa Bay Times’ Top Workplaces.

Summary

Position Highlights:

The Clinical Research Coord. Associate (CRC Assocc.) is a support position that administers duties related to the collection of data and/or the coordination of clinical trials, at Moffitt Cancer Center. Activities support assigned research protocols and include the coordination activities of assigned research protocols (generally non-therapeutic in nature) including obtaining informed consent from study participants, specimen collection and data entry. The job is a pre-entry position for the Clinical Trials Coordinator career path or other medical or research career paths.

Other job duties may include support of therapeutic studies including completion of data entry into various database systems, follow-up of patients according to protocol (via review of records, clinic visit or telephone call), ordering supplies, preparing patient/participant documents for study visits, assisting with the maintenance of regulatory documents, communicating with study sponsors and facilitating the collection of study-required specimens.

The position applies job skills and company policies and procedures to complete assigned tasks. Within its administrative support duties, it receives moderate supervision. The assignments are semi-routine in nature but the CRC Assoc. recognizes the need for occasional deviation from accepted practice. Requires instructions only on new assignments.

Credentials and Qualifications:

• Associates degree required, in lieu of Associates degree 2 years of relevant experience with a high school diploma or GED.

Preferred:

• Hands on research experience preferred with one year experience in the oncology research setting.

Responsibilities:

Technical Coordinator Functions

• 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.

Administrative management of non-treatment 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.

Regulatory Functions

• 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.

Departmental Functions

• 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.

Data Management

• 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.

Educational/Professional

• 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.

Salary Range

$21.65 - $33.05

Salary ranges posted for this position represent the expected base pay range for the role. Actual compensation may vary based on location and a variety of job-related factors, including experience, skills, education, and internal equity among Team Members in similar positions.

We are committed to maintaining fair and equitable pay practices and regularly review compensation to ensure alignment across our workforce.

Moffitt Career Site

If you have the vision, passion, and dedication to contribute to our mission,

then we have a place for you!

1. Equal Employment Opportunity

Moffitt Cancer Center is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran or disabled status. We seek candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence.

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Why Work at Moffitt?

Careers

Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer.

As the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, Moffitt employs some of the best and brightest minds from around the world. Join a dedicated team of nearly 11,000 who are shaping the future we envision. Moffitt has been recognized as a Best and Brightest Company to Work For in the Nation and is continually named one of the Tampa Bay Times’ Top Workplaces.