This position is responsible for the development and authoring of investigator initiated protocols in coordination with clinical investigators, study teams, and sponsors. This includes the submission and management of IND/IDE applications to the FDA, ClinicalTrials.gov submissions, and coordination with UF Health Cancer Center pre-award, post-award, and regulatory team members.
The essential functions of this position are:
Protocol Authoring and Maintenance:
Manages clinical and protocol development functions of clinical trials and/or drug studies Coordinates the authoring of research protocols, informed consent documents, and other study related materials in accordance with UF, FDA, ICH and GCP guidelines. Responsible for maintaining version control of all trial related documents. Acts as a liaison between UF and industry sponsors/collaborators. Maintains direct communication with investigators, clinic departments, funding sponsors, and research collaborators in support of the overall research plan; reports start-up progress to PIs and study staff ensuring transparency during the process and identifying any issues. Collaborates with investigators, study staff and database support staff to develop data capture plan and tools. Organizes study protocol/operations conference calls, e-mail communications, and meetings. Tasks include polling call participants, distributing call announcements, agenda, meeting materials and minutes. Helps to ensure study team adheres to established timelines for project completion and reporting including posting of routine updates and results to clinicaltrials.gov.
Coordination of Regulatory Services for IIT Protocols:
Responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board policies and procedures as well as other regulatory policies and procedures regarding human subject research.
Submits new projects to the various UF IRBs by reading and understanding study protocols, obtaining HURRC and other ancillary committee approval, collaborating with study sponsors, study coordinators, Research Administrators and/or Principal Investigators to obtain and provide the IRB with accurate information. Initiates the project submission and facilitation by obtaining all required signatures, attending IRB meetings, professionally responding to reviewer questions or comments, preparing IRB-01 explicit change or tabled responses, performing a quality assurance review of approved documents to detect inaccuracies, entering complete study information in database, and distributing approved documents to appropriate locations.
Responsible for independently and accurately initiating reviews for amendments, annual renewals, study closures, DSMB and/or audit reports, serious adverse events as well as other miscellaneous items that require board review. Tracks reviews and renewal deadlines to ensure that project approvals do not lapse.
IND/IDE Applications and Submissions:
Responsible for collaborating with investigators to draft IND/IDE submissions and submitting the initial study packet and any revisions or annual updates to the FDA. Adheres to a consistent style and format for submission templates, content for IND applications, and guidelines for clinical documentation. Responds to FDA queries and requests for amendments or revisions to IND/IDE filings.
Quality Assurance and Statistical Analysis:
Works with study teams to develop new objectives, goals, and performance measures for the study; works closely with study teams to ensure that the study direction is implemented timely and effectively. Sources document verification and quality control of data entered into OnCore case report forms. Responsible for running reports and providing clear and comprehensive data sets to investigators. Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate personnel. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors
Coordination of Clinicaltrials.gov Filings and Submissions:
Responsible for timely registration and periodic maintenance of IIT trials in Clinicaltrials.gov. Responsible for entry/upload of results data and publications.
Manuscript Editing and Authoring
Assists with data management, organization, and analysis of clinical research information. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress and final reports. Assists investigators with poster, abstract, and manuscript layout/authoring including conducting literature searches and reference verification.
Supports and Facilitates Industry Sponsored Clinical Trial Start-ups:
Reviews potential protocols for feasibility by communicating protocol requirements with ancillary support departments such as Radiation Therapy, Pathology, Surgery, Radiology and Laboratory to determine if adequate resources are in place for protocol activation. Communicates feasibility assessment to representatives of the Disease Site Groups (DSG) and/or Principal Investigator. Collaborates with CTO Research Administrator(s) to develop study budgets and expend funds. Serves as point person for the designated DSG(s) as protocols are reviewed by the DSG, PRMC, and queued for IRB/WIRB submission. Manages regulatory submission of new protocols for assigned DSG(s) in collaboration with designated IRB coordinator. Attends Institutional Review Board meeting and responds to questions accurately and professionally. Identifies education/inservice issues for protocol activation and collaborates with assigned study coordinator to ensure that education and inservices are completed in a timely manner in relation to protocol activation. Serves as the point person for protocols that will be submitted to the General CTSI Clinical Research Center.
Bachelor's degree and three years of experience in grant and contract administration; or an equivalent combination of education and experience.
Experience with Excel and Word
Experience with databases
Ability to work independently, interact professionally and possess effective writing and organizational skills.
Previous experience as a study coordinator or monitor
We are the University of Florida Health Cancer Center – more than 250 researchers and clinicians at the University of Florida and Shands HealthCare who conduct research for the prevention, early diagnosis and treatment of cancer. The center’s collaborative research model encourages the translation of basic laboratory findings to novel curative and preventive therapies.The multidisciplinary members...hip of the Cancer Center is its strength. Researchers are drawn from throughout UF, including six colleges within the Health Science Center – Medicine, Nursing, Dentistry, Pharmacy, Public Health and Health Professions, and Veterinary Medicine. Exciting collaborations with the College of Engineering are enabling scientists to use UF’s “supercomputer,” nanotechnology, and other technological advancements to develop new therapies and techniques. Additional collaborations occur within dozens of UF multidisciplinary centers and institutes, including the McKnight Brain Institute, Proton Therapy Institute – one of only seven such facilities in the nation – Genetics Institute, Clinical and Translational Science Institute, Institute on Aging, and Emerging Pathogens Institute.Our mission is and will always be dedicated to:Providing state-of-the-art cancer treatment, prevention, control and educationConducting original scientific research aimed at discoveryFostering collaboration to turn research findings into new therapiesAnd, ultimately, offering hope in the face of a daunting diagnosisOur goal is to generate tomorrow’s answers for today’s patients.