Protocol Navigator

4 weeks 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.
  • Assist Principal Investigators (PI) with development of clinical research protocols, informed consent forms (ICFs), and other study documents by completing standard wording for regulatory sections as well as reviewing / revising other sections of documents for consistency.
  • Ensure consistency within protocol and between protocol and ICF.
  • Maintain proper and consistent communication with PIs/research teams by attending regular study/team meetings or calls to stay on track of development of study documents.
  • Act and liaison and main Point of Contact between Institutional Review Board (IRB), sponsor, and other sites.
  • Distribute appropriate forms for PI, Peer Reviewers and Branch Chiefs, assist PIs in incorporating suggested changes and respond to reviewers' comments and collect all forms and PI responses to prepare a Branch Review packet.
  • Manage completion of Resource Assessment Forms (PRIA), Travel Reimbursement Forms (DRTS), Ethics Clearance submissions (DEC) and Radiation Safety Committee submission (RSC) (when applicable) and respond to OPS (Office of Protocol Service) Protrak requests.
  • Prepare submissions, new and periodic, for Ancillary Review and IRB committees.
  • Working with assistance of research team and data managers, prepare and submit continuing reviews, protocol amendments, various other IRB submissions in consultation with PI.
  • Assist with preparing and submitting materials for Annual and Quadrennial Scientific review submissions.
  • Maintain Regulatory Binder, assist research team with monitoring visits regarding the regulatory binder.
  • Be flexible and agile shifting priorities in supporting research teams.
What You Will Need:
  • Bachelor's degree in field such as Biomedical Sciences or similar discipline
  • At least FOUR (4) years of experience working with clinical trial protocols.
What Would Be Nice To Have:
  • Ability to work independently and in a team environment.
  • Strong written and verbal communication skills.
  • Experience managing IRB submissions desired, but not required.
  • Able to format documents using the MS Office suite - Word, PowerPoint, Excel.
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 [redacted] or via email at RecruitingA[redacted]. 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.

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