CCRC (Certified Clinical Research Coordinator), CCRP (Certified Clinical Research Professional)
This position has University-wide impact and works within the Office of Research under the Office for Clinical Research Advancement (OCRA) initiative. The Clinical Research Navigator directs the design, development, implementation and evaluation of the Clinical Research Navigation program for the University. This includes policies and procedures that govern the program and strategic directives for actualization of program goals and objectives. The Clinical Research Navigation program provides services and guidance to FSU clinical and translational researchers in order to enhance the quality, efficiency, regulatory sufficiency and overall impact of their work.
Provides strategic direction to and oversight of the Clinical Research Navigation Program as the University’s central resource for clinical research and clinical trials. Directs the development and delivery of policy and practice to guide the FSU clinical research community on complex issues; study aims; research methodologies; ethical considerations; University, federal, and state regulatory requirements; and institutional policies related to clinical research. This includes: Directing the delivery or facilitation of researcher access to FSU or external research resources needed for a study, including but not limited to: protocol development/review; regulatory compliance guidance; identification of funding opportunities and collaborators; grant-writing and budget development; biostatistics/bioinformatics; intellectual property & commercialization services; guidance on Responsible Conduct of Research; IRB preparation and submission processes; study startup/implementation; Contract Research Organization (CRO) assistance; data accrual and management; publication and other dissemination assistance.
Provide centralized University oversight for the ClinicalTrials.gov regulatory requirements to ensure that FSU investigators using the site will timely address federal reviewer requests to correct errors, deficiencies and/or inconsistencies in their submitted study information.
Direct the design and delivery of educational and training materials, user guides, special events and other learning opportunities for researchers, including information on FSU-based and external resources available to investigators. Oversight of the development and implementation of policies and procedures for designing, delivering, evaluating and improving standardized training and educational programs for FSU researchers related to clinical research.
Provide guidance, tools, resources and program direction for helping researchers to successfully navigate the life cycle of a study at any point, from conception and planning, implementation and execution, to analysis and publication of data and outcomes.
Plan and ensure the design and execution of a website for the Office for Clinical Research Advancement, as well as other communication/social media venues, to keep FSU researchers apprised of the changing clinical research landscape and clinical research opportunities.
Maintain current knowledge of federal and state regulations regarding human subjects protections and the ethical conduct of research, including Office for Human Research Protections, Food & Drug Administration/Good Clinical Practices, Health Insurance Portability & Accountability Act, Health Information Technology for Economic and Clinical Health and related requirements, as well as monitor, analyze, interpret and direct the dissemination of information about related developments and implications for the FSU clinical research community.
Collaborate with internal and external stakeholders and others with related interests, including University research executives, research faculty, students, staff and community healthcare providers, to evaluate, recommend and direct the development of new support services for improving the research enterprise at FSU. Other duties as may be assigned.
Bachelor’s degree in a health sciences/health-related field and a minimum of six (6) years’ experience working in human subjects or clinical research, or a combination of post high school education and the same experience equal to ten years.
Knowledge of federal regulatory requirements involving human subjects research and protections, including working with IRBs, HIPAA/HITECH requirements, the FDA and Good Clinical Practice.
Ability to communicate effectively verbally and in writing.
Ability to demonstrate skills in customer service, critical thinking, multi-tasking and problem-solving.
Ability to develop and implement policies, procedures, strategic goals and objectives.
Ability to understand and interpret educational needs and to develop effective instructional media solutions.
Experience with applicable computer applications and basic computer functions to include Microsoft Word, Excel, Outlook and PowerPoint or equivalent software.
Master’s degree or higher in public health or other health sciences/healthcare professional fields.
Experience in translational science and/or clinical trial research activities, including commercial, federal and PI-initiated protocols.
Proficiency with medical terminology in a research setting.
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Profession (CCRP).
Ability to interpret research contracts, study budgets, clinical protocols and consent forms.
Experience working in a university research setting strongly preferred.
Anticipated Salary Range
Salary will be commensurate with education, skills and experience.
Criminal Background Check
This position requires successful completion of a criminal history background check. The background check will be conducted as authorized and in accordance with University Policy 4-OP-C-7-B11.
This is an A&P (Administrative & Professional) position.
How To Apply
If qualified and interested in a specific job opening as advertised, apply to Florida State University at https://jobs.fsu.edu. If you are a current FSU employee, apply via myFSU > Self Service. Job ID 46337
Applicants are required to complete the online application with all applicable information. Applications must include all work history up to ten years, and education details even if attaching a resume.
Tobacco Free Campus
Effective January 1, 2014, tobacco use, including simulated tobacco use, is prohibited on property, interior and exterior, owned or managed by Florida State University. This policy applies to all Florida State University students, employees, consultants, contractors, visitors, and external individuals.
Equal Employment Opportunity
An Equal Opportunity/Access/Affirmative Action/Pro Disabled & Veteran Employer.
FSU's Equal Opportunity Statement can be viewed at: http://www.hr.fsu.edu/PDF/Publications/diversity/EEO_Statement.pdf
Soft Money Funded Position
This is a soft money funded position, with renewal based on available funds and the needs of the University
Open until filled.
Internal Number: 46337
About Florida State University
Office of the Vice President for Research
On any given day at Florida State University, you will find faculty members and their students in the lab or in their studio working on the problems that face our world.
That could mean finding a cure for the Zika virus or studying how changes in the carbon cycle affect our climate. It could mean developing next-generation solar cells or exploring how the rise of autonomous vehicles will affect our laws and urban infrastructure.
Or on a more creative side, it could mean using art to tell the history of ancient Italy or developing original choreography to explain the hardships of war through dance.
The Florida State University Office of Research is the administrative arm that supports these researchers in their scientific and creative endeavors. Managing on average more than $200 million in research awards from state, federal and private sources, the Office of Research staff focuses its efforts on helping faculty move their work forward at every stage of the research process from identifying potential funding opportunities to protecting intellectual property to identifying potential industry partners.
More than ...115 staffers comprise the staff of the Office of Research, including professionals in proposal development, communications, technology transfer, sponsored research administration and more.
ABOUT THE VICE PRESIDENT OF RESEARCH
Vice President for Research Gary K. Ostrander directs the Office of Research and all aspects of the university’s $200 million enterprise, including its research centers, programs and institutes.