Clinical Research Assistant - UF Health Cancer Center

Location
Gainesville FL
Posted
Oct 12, 2017
Institution Type
Four-Year Institution

Classification Title:

Clinical Research Assistant

Job Description:

The Cancer Center at the University of Florida is seeking applicants to fill a Clinical Research Assistant position.

This clinical research assistant position (data manager) participates as a member of a multi-disciplinary team in the conduct of clinical research trials, collection of subject data and clinical samples and documentation for the University of Florida Health Cancer Center Clinical Trials Office. The position will independently collaborate with investigators, physicians, nurses and other key personnel to ensure compliance with protocol requirements.

Independently coordinate all aspects of non-therapeutic clinical research trials by (1) identifying possible clinical trial candidates by attending rounds and/or patient care conferences; (2) reviewing and interpreting source documentation to confirm subject eligibility for clinical trial participation; (3) reviewing informed consent documents with subjects or legally authorized representatives; (4) confirming proper execution of informed consent documents; (5) registering subjects on non-therapeutic clinical research trials; (6) following subject’s clinical course; (7) collaborating protocol requirements with Registered Nurse Specialists, Physicians and/or other key personnel; (8) collecting protocol-required data from medical records, including medical history, diagnosis, pathology, laboratory, radiology, specialty test results, progress notes and reported side effects or adverse reactions; (9) accurately entering data on paper case report forms or into a computerized database; and (10) maintaining case report forms in compliance with privacy laws.

Assist Registered Nurse Specialists with the conduct of therapeutic clinical research trials by (1) obtaining medical records and subject reports from local and non-local facilities; (2) collecting protocol-required data from medical records; (3) entering data on paper case report forms or into a computerized database; (4) reviewing data with Registered Nurse Specialists for accuracy and completeness; (5) submitting data to study sponsors according to protocol timelines; and (6) obtaining additional data as requested by Registered Nurse Specialists.

Coordinate the procurement of research samples by (1) submitting orders for the collection of samples; (2) confirming samples are appropriately labeled; (3) processing samples according to sponsor requirements; (4) storing samples appropriately until shipment; (5) preparing samples for transport at room temperature, on ice packs or on dry ice; (6) preparing differential and/or pathology slides; (7) collecting radiological films and/or CDs; and (8) transporting samples and/or radiological films in accordance with protocol, local, state and federal requirements.

Responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board  and Shipping and Transport of Biologic Materials policies and procedures as well as other regulatory policies and procedures regarding human subject research.

Prepare Institutional Review Board continuing review reports by (1) independently and accurately completing continuing review/study closure report forms and attaching required documentation such as cumulative adverse event tables, de-identified signed informed consent documents, data safety monitoring board reports and/or audit reports; (2) submitting documents to CTO staff within appropriate timelines in order to prevent project expiration or sponsor deficiencies; (3) tracking paperwork from initial submission to CTO IRB staff to receipt of final approval documents; (4) reviewing approval documents for accuracy and completeness; (5) entering updated approval dates in database; (6) filing approval documents in regulatory and/or study binders; (7) distributing new documents to patient care units; and (8) alerting Registered Nurse Specialists and ancillary staff of new documents.

Submit serious adverse events, IND reports, protocol addenda or other documents to CTO IRB staff by (1) reviewing information to determine appropriate reporting requirements; (2) preparing CTO IRB submission forms; (3) reviewing submission forms and sponsor information with Registered Nurse Specialists for accuracy; (4) tracking paperwork from initial submission to CTO staff to receipt of final approval documents; (5) reviewing approval documents for accuracy and completeness; (6) entering updated approval dates in database; (7) filing approval documents in regulatory and/or study binders; (8) distributing new documents to patient care units; and (9) alerting Registered Nurse Specialists and ancillary staff of new documents.

Maintain up-to-date comprehensive regulatory and/or study binders. Provide sponsors with updated regulatory documents. Copy protocols, consents and Institutional Review Board documents. Perform regular quality assurance reviews of local and remote working files. Perform other duties as assigned.

Activities include but are not limited to: completing annual competencies as required by the University of Florida and Institutional Review boards; participating in professional development and continuing education, and other duties as assigned. Interface with database support personnel to provide an organized system for collection of clinical trials data from affiliates. Maintain running protocol status report of trials opening at affiliate sites. Follow affiliate trial interest from interest to activation. Coordinate creation of annual reports to include preparation of tables with data on research affiliation clinical trial activity, compilation of research affiliate financial reports, cost/benefit analysis, document formatting.

Communication and Administration
Serve as a regulatory liaison with institutional, local, state, and federal external agencies, communicating directly with agency personnel as necessary. Manage meeting and conferences related to group administration as required. Attend meetings as required.

Assist with pre-audit coordination for NCI/Sponsor audits to include but not limited to scheduling, securing space, catering, hosting auditors while on site, pre- and post- audit communication, and centralized coordination of response to final audit findings. Serve as a liaison between the CTO and its partnering sites, and other agencies and departments. Maintain regular contact and exchange of information with partners and other external entities in order to fulfill the clinical and research obligations of the CTO. Develop and maintain other relationships as warranted to benefit the CTO. Serve on taskforces for special projects for the CTO.

Advertised Salary:

$14.25 – 16.75 hourly; commensurate with education and experience

Minimum Requirements:

High school diploma or equivalent and one year of relevant experience; or an equivalent combination of education and experience.

Preferred Qualifications:

Experience with Excel, Word and databases required. Required to work independently, interact professionally and possess effective writing and organizational skills.

Special Instructions to Applicants:

Applicants must upload a copy of the following documents to be considered for this position:

  • Cover Letter or Letter of Interest
  • Résumé
  • List of References

 This is a time-limited position.

Health Assessment Required:

Yes