CCRC (Certified Clinical Research Coordinator), PMP (Project Management Professional)
As the Protocol Development Manager you will lead the Protocol Development team and provide general oversight of the development if clinical research protocols by your team. In the execution of your duties, you will oversee the development and authoring of investigator initiated protocols and manage both local and multi-site IITs and will require coordination with UF Health Cancer Center pre award, post award, regulatory team members, core committees, Feasibility Group, and statistical team. In your new role you will be responsible for the following:
Unit Oversight & Management
A significant function of this Manager is focused on ensuring that systems are in place for the effective, efficient, and accurate conduct of clinical trials. You will work with other Managers, CRO Leadership, and UFHCC HR to develop and implement these systems and will play a critical part in determining the direction and tone of these programs.
In developing your team, you will be responsible for the ongoing workload assessment and reassignment of work as needed across your division and will help direct recruitment efforts and performance management. This includes the development of training and onboarding programs, drafting position descriptions, providing mentorship to Protocol Development staff on protocol authoring, study activation, regulatory body (FDA, IRB, GCP, etc.) updates, oncological, clinical research, and patient care topics, as well as the establishment of clear, measurable performance expectations for the unit. Additionally, in your capacity as Manager, you will manage resolution and problem-solving efforts for issues arising from the conduct of clinical research, collaborating with critical partners throughout UF and UF Health.
You will also act as a resource for your staff with the implementation of clinical research protocols and review of complex regulatory cases, providing guidance informed by your extensive experience and expertise in clinical research topics. You may also be called upon to serve on internal committees for the creation of SOPs, workflows, and metrics as well as to participate in working groups and coordinate internal quality control activities in conjunction with internal Monitors and other related staff and to collaborate with leadership and support staff to implement and change policies and/or procedures.
You will be responsible for overseeing and ensuring the compliance of the entire CRO portfolio and for serving as back-up for Protocol Development Coordinators in the conduct of their assigned duties. This will include overseeing training for protocol development activities such as committee management, DSG and SRMC submission, cost coverage analysis, etc. as well as CTMS entry, establishing and maintaining workflow timelines and workload matricies, and data analysis related to clinical trial development activity.
In addition to this, you will serve as liaison with OnCore staff within the Office of Clinical Research and in building and maintaining partnerships on behalf of the Cancer Center. You will also work with the Associate, Administrative, and Assistant Director and liaise with outside entities who wish to conduct trials at UFHCC.
Protocol Development Activities
You will also manage your own portfolio of IIT protocols and coordinate its development activities. This will include managing the clinical and protocol development functions of these studies and coordinating the authoring of research protocols and other study related materials in accordance with regulatory guidelines. As part of this process you will act as liaison between UF and industry sponsors/collaborators and will be responsible for maintaining communication between involved parties in support of the research plan and communicating updates to PIs and study staff. You will also collaborate with investigators and other staff to develop data capture plans and tools.
You will also be responsible for the coordination of regulatory services for your protocols with IRB Specialists and necessary offices and for maintaining your understanding of the relevant policies, procedures, and guidelines related to human subject research. You will also partner with study teams to develop new objectives, goals, and metrics for the study, as well as to ensure direction is implemented effectively and according to established timelines. Part of your responsibility for the study process will include source document verification, providing reports and data to investigators, cooperating with compliance and monitoring efforts related to sponsored program administration, and assisting with data management, analysis, and organization.
You will also assist investigators with poster, abstract, and manuscript layout and authoring, including conducting literature searches and reference verification.
Clinical Trial Support
You will be also be responsible for incorporating medical knowledge into the review of clinical aspects of potential protocols. This is a critical element of the development process and includes reviewing studies for clinical processes and feasibility, as well as for providing guidance to research staff in the administration and toxicity assessment of protocol regimens. Additionally, you will provide inservice education to research staff as needed to facilitate protocol compliance.
Master’s degree in appropriate area of specialization; or a bachelor’s degree in appropriate areas of specialization and two years of experience.
As an ideal candidate you will have:
Master’s in Nursing, Basic Sciences, and/or Health Care and ten or more years of research experience and/or medical/clinical training;
Expert knowledge and understanding of oncological and clinical research concepts and terminology;
Experience with databases and/or patient data;
Experience with Medicare Coverage Analysis determinations;
Proficiency with Microsoft Office suite, particularly Excel, Word;
Ability to successfully work independently, interact professionally, and utilize effective writing and organizational skills;
Proficient time management skills and ability to successfully manage multiple priorities;
Demonstrated proficiency in project management, clinical research/trials experience is highly desirable;
Licensure as a registered professional nurse in accordance with Chapter 464 Florida Statutes or eligibility to practice nursing in accordance with Section 210 Florida Administrative Code;
Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc.) are required at the earliest of 12 months from hire or eligibility.
Additional Salary Information: Please visit https://benefits.hr.ufl.edu/ for information regarding available benefits.
Internal Number: 00031366
About UF Health Cancer Center
At the UF Health Cancer Center our mission is to prevent, detect, treat, and ultimately cure cancer while addressing the unique challenges of the cancer burden faced by the population we serve. Whether working directly in clinical trials with our faculty researchers and patients or operating behind the desk in administration, each of our employees has a critical role to play in the success of our Center and the discoveries that are made here.
The Cancer Center serves as the nucleus for the diverse institutional programs of research, education, and clinical approaches that are necessary to improve cancer outcomes. With more than 250 researchers and clinicians at the University and UF Health conducting research for the prevention, early diagnosis, and treatment of cancer our collaborative research model encourages the transition of basic laboratory findings to novel curative and preventative therapies. This multidisciplinary membership is our strength, and our net is cast wide. Researchers are drawn from 69 departments and 11 colleges across the University and collaborate with dozens of other UF multidisciplinary centers and institutes—including the McKnight Brain Institute, Prot...on Therapy Institute (one of only seven such facilities in the nation), Genetics Institute, Clinical and Translational Science Institute, Institute on Aging, and the Emerging Pathogens Institute, among others.