Clinical Research Protocol Navigator

4 weeks ago

BETHESDA, United States Guidehouse Full time

Job Family:

Clinical Trial Operations (Digital)


Travel Required:

None


Clearance Required:

Ability to Obtain Public Trust

What You Will Do:
 

​​We are currently searching for a Clinical Research Protocol Navigator to provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned. This role is centered around clinical research protocol and informed consent document development and requires expert writing skills. This role also includes Institutional Review Board (IRB) submissions, regulatory document management, amongst other regulatory study tasks. This is a full-time, on-site opportunity in Bethesda, MD.    

  • Develop and review completed new and amended clinical research protocols and related documentation throughout the lifecycle of the study, with special attention to the accuracy, consistency, and completeness of documents.  
  • Electronic Data Capture System
  • Electronic Medical Records System (EMR)  
  • Clinical Trial Management System (CTMS) 
  • Strong writing skills with experience writing clinical research protocols. 
  • On-site visits 
  • IRB submissions 
  • Clinical Research & Data Integrity 
  • Protocol development & navigation 
  • Regulatory compliance & regulatory affairs 
  • Clinical Trial Phase I or II experience. 
  • Training clinical trial site staff  
  • Liaising with regulatory authorities 
  • Certified clinical researcher with one of the following accredited organizations: Association of Clinical Research Professionals Certified Professional (ACRP-CP); Association of Clinical Research Professionals (ACRP); Certified Clinical Research Professional (CCRP); Certified Clinical Research Coordinator (CCRC); Certified Clinical Research Associate (CCRA) 



  • What Would Be Nice To Have:

  • Preferred areas of study are nursing, biology, general science, general medical and health services, or similar disciplines. 
  • Familiar with using electronic medical record systems
  • Previous clinical trial experience 
  • At least 3 years of experience 


  • What You Will Need:

  • Master’s Degree 
  • Develop training plans and train staff on the proper techniques for protocol submission. 
  • Review and maintain trial related documents and operational procedures. 
  • Collect, distribute, file, and submit regulatory documents. 
  • Review clinical research protocols and related documentation throughout the developmental process, and prior to submission for accuracy, consistency, and completeness and recommends changes as needed. 
  • Work with the NINDS Clinical Trials Unit (CTU) and NINDS staff on the development and preparation of standard operating procedures SOPs pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research Program. 
  • Assist researchers collect, distribute and file regulatory documents. 
  • Maintain study databases and conduct basic analysis. 
  • Assist researchers with protocol development, assembly, maintenance, and review of clinical trial documents and operational procedures. 
  • Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports.  
  • Develop new and review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.   
  • Prepare new and review completed study reports and status updates, including amendments, audits, and other administrative documentation.  
  • Develop new and review completed clinical research informed consent and other ethics and regulatory related documentation.   


What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

  • Medical, Rx, Dental & Vision Insurance

  • Personal and Family Sick Time & Company Paid Holidays

  • Parental Leave

  • 401(k) Retirement Plan

  • Group Term Life and Travel Assistance

  • Voluntary Life and AD&D Insurance

  • Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts

  • Transit and Parking Commuter Benefits

  • Short-Term & Long-Term Disability

  • Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities

  • Employee Referral Program

  • Corporate Sponsored Events & Community Outreach

  • Care.com annual membership

  • Employee Assistance Program

  • Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)

  • Position may be eligible for a discretionary variable incentive bonus

About Guidehouse
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.


Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.


If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.


Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

  • Clinical Research Protocol Navigator

    4 weeks ago

    BETHESDA, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustWhat You Will Do:We are currently searching for a Clinical Research Protocol Navigator. The primary role for this Protocol Navigator (PN) position is to provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU)...

  • Clinical Research Protocol Navigator

    3 weeks ago

    Bethesda, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustWhat You Will Do: We are currently searching for a Clinical Research Protocol Navigator to provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific...

  • Protocol Navigator II

    4 weeks ago

    Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    Protocol Navigator II - NHLBI (LOCAL/Remote)Job ID: req4053Employee Type: exempt full-timeDivision: Clinical Monitoring Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI)...

  • Clinical Research Protocol Specialist

    2 weeks ago

    Bethesda, Maryland, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustPosition Overview:We are seeking a Clinical Research Protocol Navigator to provide essential regulatory support for clinical research activities. This role is integral to the NINDS Clinical Trials Unit (CTU) and involves collaborating with...

  • Protocol Navigator III

    4 weeks ago

    Bethesda, United States Frederick National Laboratory for Cancer Research Full time

    Protocol Navigator III - NHLBI (LOCAL/remote) Job ID: req4054Employee Type: exempt full-timeDivision: Clinical Monitoring Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute...

  • Protocol Navigator II

    4 weeks ago

    Bethesda, United States Frederick National Laboratory for Cancer Research Full time

    Protocol Navigator II - NHLBI (LOCAL/Remote) Job ID: req4053Employee Type: exempt full-timeDivision: Clinical Monitoring Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute...

  • Clinical Research Protocol Specialist

    2 weeks ago

    Bethesda, Maryland, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustRole Overview:We are seeking a Clinical Research Protocol Specialist to provide essential regulatory support for clinical research initiatives. The primary responsibility of this position is to facilitate the development of clinical research...

  • Clinical Research Protocol Specialist

    2 weeks ago

    Bethesda, Maryland, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustKey Responsibilities:We are seeking a Clinical Research Protocol Specialist to deliver regulatory support for clinical research through the NINDS Clinical Trials Unit (CTU) within the NINDS Intramural Research Program. This position focuses on...

  • Protocol Navigator

    1 month ago

    Bethesda, United States Guidehouse Full time

    Job Family: Administrative Services (Digital) Travel Required: None Clearance Required: Ability to Obtain Public Trust What You Will Do: We are currently searching for a Protocol Navigator to support the National Institutes of Health (NIH). This opportunity is full-time, on site in Bethesda, MD and may be eligible for telework after successful orientation. ...

  • Clinical Protocol Coordinator

    3 months ago

    Bethesda, United States Cape Fox Federal Contracting Group Full time

    Job Description Concentric Methods is seeking a Clinical Protocol Coordinator to join our ream in Bethesda, MD in support of the NIH. Responsibilities: Assists researchers with protocol development, assembly and review of clinical trial documents. Assist researchers develop, prepare internal research proposals, abstract submissions, poster...

  • Clinical Research Protocol Specialist

    2 weeks ago

    Bethesda, Maryland, United States Axle Full time

    Job OverviewAxle is a pioneering organization in the fields of bioscience and information technology, dedicated to enhancing translational research, biomedical informatics, and data science applications for research institutions and healthcare entities both domestically and internationally. Our team comprises specialists in biomedical science, software...

  • Protocol Nurse Coordinator II/III

    4 weeks ago

    Bethesda, United States Frederick National Laboratory for Cancer Research Full time

    Protocol Nurse Coordinator II/III Job ID: req4058Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by...

  • Protocol Nurse Coordinator II/III

    4 weeks ago

    Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    Protocol Nurse Coordinator II/IIIJob ID: req4058Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos...

  • Clinical Research Compliance Specialist

    2 weeks ago

    Bethesda, Maryland, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustKey Responsibilities:We are seeking a Clinical Research Protocol Navigator to provide essential regulatory support for clinical research initiatives. This role is pivotal in the development of clinical research protocols and informed consent...

  • Clinical Research Compliance Specialist

    2 weeks ago

    Bethesda, Maryland, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustKey Responsibilities:We are seeking a Clinical Research Protocol Navigator to provide essential regulatory support for clinical research initiatives. This position focuses on the development of clinical research protocols and informed consent...

  • Clinical Research Compliance Specialist

    2 weeks ago

    Bethesda, Maryland, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustPosition Overview:We are seeking a dedicated Clinical Research Protocol Navigator to provide essential regulatory support within the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program. This role focuses on the development...

  • Clinical Research Nurse III

    3 months ago

    Bethesda, United States Frederick National Laboratory for Cancer Research Full time

    Clinical Research Nurse III - Genitourinary Malignancies Branch (GMB) Job ID: req3982Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National...

  • Clinical Research Nurse III

    2 months ago

    Bethesda, United States Frederick National Laboratory for Cancer Research Full time

    Clinical Research Nurse III - Center for Immuno-Oncology (CIO) Job ID: req3984 Employee Type: exempt full-time Division: Clinical Research Program Facility: NIH Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer...

  • Clinical Research Nurse III

    3 months ago

    Bethesda, United States Frederick National Laboratory for Cancer Research Full time

    Clinical Research Nurse III - Center for Immuno-Oncology (CIO) Job ID: req3973Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer...

  • Clinical Research Nurse

    3 weeks ago

    Bethesda, United States Astrix Full time

    NIH Hierarchy:National Institutes of Health (NIH)National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Roles/Responsibilities:Coordinate patient schedules, data collection, and nursing care. Assist physicians with skilled procedures. Coordinate with other research nurses, providers, patient care coordinators, and other NIH staff to...