Clinical Research Navigator (Finance)
Nemours is seeking a Clinical Research Navigator to join our team in Wilmington, DE
The Clinical Research Navigator will serve as a resource for Principal Investigators, at Nemours Children's Health, to help enrich and facilitate the conduct of clinical research from conception to completion. The incumbent will be the first point of contact for all faculty interested in pursuing clinical research protocols and continue to serve as a resource in the navigation of investigator-initiated and industry clinical trials. The incumbent will assist the Principal Investigator in identifying resources and services available to facilitate a successful clinical research project (regulatory, biostatistics, informatics, clinical research resources, etc.). This role will partner with the Regional and Enterprise Leadership of Research to help guide investigators through the clinical research life cycle and ensure alignment with Nemours policies and procedures. The Navigator also tracks metrics to assess program impact, supports compliance with federal and institutional policies, and facilitates collaborations among investigators, various departments and Nemours resource teams. The Navigator is detail-oriented, proactive, and skilled in fostering relationships and providing support to investigators in the conduct of clinical research.
Navigators will serve as a single point of contact for investigators and research staff at Nemours Children's Health who need information and resources to initiate or execute their clinical or translational research studies. Resources include but are not limited to resources within the Office of Clinical Research Services (OCRS) and Nemours Children's Health Research infrastructure. All Navigators will work independently to provide high-level assistance, counsel, and problem-solving advice to faculty and staff who seek the support to conduct clinical research projects.
Essential Functions:
1. Guide investigators through the application process from submission to closure.
2. Support investigator initiated minimal risk clinical research project start up and facilitation.
3. Establish and nurture partnerships with Nemours Children's Health core research labs, research resources, and community organizations to enhance resource sharing and collaboration.
4. Provide individualized consultation to investigators, offering guidance on addressing review feedback and refining proposals for future funding opportunities.
5. Serve as a liaison between investigators and the Office of Clinical Research Services, ensuring that all awarded projects receive dedicated project management support.
6. Remain informed about current developments in clinical and translational science by regularly engaging with relevant literature, attending seminars, and participating in research workshops and conferences.
7. Develop new and review completed Investigational Drug and Device safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports if projects include Investigational Drug or Investigational Devices. This includes submissions to the FDA and management of the project on clinicaltrials.gov.
8. Organize regulatory protocol meetings and/or reports, as well as attend other research team staff meetings; interact closely with the research clinical team and other staff involved in protocol management; guide the protocol navigation process.
9. Compile summary reports and metrics related to clinical research activities.
10. Additional miscellaneous duties and responsibilities may be assigned from time to time to help projects move forward. Examples include regulatory submissions, data collection, etc.
Job Requirements:
Bachelor Degree required, preferably in Biological Sciences, Biomedical Research or related health degree.
Certification through Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (OCRA) is preferred
Minimum five years of clinical research experience (or 3 years of RN experience) is required.
Education on human subject research and Good Clinical Practice is required.
Knowledge of clinical trials and regulations (local, state, and federal) is required.
Familiarity with basic scientific and healthcare principles and terminology is required.
Experience with Electronic Medical Records System and Electronic Data Capture System is required; Clinical Trial Management System (CTMS) software is preferred.
Experience with training clinical trial site staff, phase I or II clinical research, and protocol development.
Strong writing skills with experience writing clinical research protocols.
