30090000 - JX-PEDIATRICS-JACKSONVILLE

MGR - Clinical Research

• Actively recruits and screens eligible patients for research protocols. Assists and conducts Informed Consent process. Completes Informed Consent quality assurance assignments as needed.
• Coordinates and implements enrollment and follow-up procedures to collect data from patient charts, medical records, interviews, questionnaires, and other sources. Cross-trains as backup on other studies as assigned. Creates protocol worksheets and source document forms as needed.
• Performs all study lab processing including centrifuging, aliquoting, storage, freezer maintenance and shipping as assigned. Interprets regulations and guidelines of multiple programs funding with complex and broad guidelines for spending.
• Assures that study-related laboratory tests and diagnostic procedures are completed, reviewed and confirmed when necessary. Completes grading of labs per DAIDS toxicity table and/or other study specific grading scale.
• Resolves any logic checks, errors, queries and delinquencies that come up with strict timeframes. Completes quality assurance assignments.
• Communicates with providers, protocol teams, sponsors, IRB, as well as others from the UF CARES staff regarding the clinical management of signs, symptoms, toxicities, abnormal labs, deviations, adverse events, etc. Advises the Principal Investigator on the most effective way to achieve an effective, quality proposal and coordinates a timely submission process, ensuring appropriate approvals. Reviews proposals for compliance with sponsor and University terms and rules, and review, negotiation and acceptance of resulting grant awards. Participates in the negotiation with grant and contracting officers to substantiate budget requests and to secure terms and conditions which are consistent with policy. Confers with investigators and campus administrators to ensure that changes or corrections are made as needed.
• Maintains contact with study patients to facilitate study retention and their care, including communication regarding study requirements, coordinates drug dispensing with Research Pharmacist, and other procedures, treatment, etc. In-services UF CARES staff and other participating staff on research protocols and topics.
• Provides preceptorship and research trainings to the new and current research coordinators. This includes LDMS, lab processing of specimen, and study related activities.
• Updates study schemas/source documentation for studies and assists with overall QA activities for the program.
• Evaluates and mentors staff. (Research Coordinators). May supervise research administration support staff for a defined unit or project.
• Understands regulatory process and IRB and FDA requirements, ensuring compliance with regulatory agencies. Completes and maintains regulatory files as assigned. Assists with regulatory submissions to IRB and sponsors.
• Maintains monthly billing for study visits and documents appropriate fees on research referral forms.
• Attends pertinent educational or study activities to include some out of town meeting and reviews current literature relevant to clinical area.

$69,900 to $85,000 annually depending on education and experience.

Master's degree in appropriate area of specialization; or a bachelor's degree in appropriate areas of specialization and two years of experience.

• Clinical Research Certification, or acquired within 2-3 years of hire.
• Two years prior experience with clinical trials, including HIV/AIDS.
• Supervisory experience.

This position has been reposted. Previous applicants are still under consideration and need not reapply.

This is a time-limited position.  Time limited positions are based on circumstances, such as funding sources, which control the length of time for which the position is available.

Background Check is Required.

To be considered you must upload your Cover Letter, Resume/CV, and 3 References.

University of Florida College of Medicine – Jacksonville:   Visit this link to watch the video

Application must be submitted by 11:55 p.m. (ET) of the posting end date.