Protocol Navigator II

Job ID: req4687
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases. Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTIONPOSITION DESCRIPTIONThis Protocol Navigator (PN) position in the CMRPD is under the Regulatory Compliance and Human Subjects Protection Program (RCHSPP) in the Protocol Navigation and Protocol Development Program (PN/PDP). The PN/PDP provides protocol navigation and medical writing support to the National Institute of Allergy and Infectious Diseases (NIAID) Intramural Clinical Research Program for the Office of Clinical Research Policy and Regulatory Oversight (OCRPRO).The PN/PDP team is composed of medical writers and navigators who assist in all stages of protocol document development from study concept through initial approval. The PN works directly with allergy, immunology, and infectious disease investigators to facilitate the review and submission of complete, accurate, and comprehensive documents that meet applicable policies and guidelines. The PN and Medical Writer (MW) work closely together in the drafting and reviewing of the study documents. The PN manages the timelines and communications with the study teams and works on submissions to the various offices needed for study approvals. The navigational activities span a breadth of research areas and include interactions in which the PN needs to accurately interpret policy and how it applies to the study, skillfully relay the study issues, and seek accurate and timely responses from colleagues within RCHSPP such as the Clinical Safety Office, Regulatory Affairs Office, and Clinical Trials Monitoring Group, as well as NIAID/NIH bodies such as the Institutional Review Board (IRB) and Scientific Review Committees, with the overall goal of reducing administrative burden for study teams and expediting the numerous reviews required for initial approval and subsequent complex amendments. KEY RESPONSIBILITIESAs part of the Protocol Navigation/Protocol Development Program (PN/PDP), the Protocol Navigator II:BASIC QUALIFICATIONSTo be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:PREFERRED QUALIFICATIONSCandidates with these desired skills will be given preferential consideration:

Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

92,900.00 - 133,215.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions