Clinical Research Protocol Navigator

Job Family:

Travel Required:

Clearance Required:

What 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) 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 IRB submissions, regulatory document management, amongst other regulatory study tasks. This is a full-time opportunity located 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.

• Develop new and review completed clinical research informed consent and other ethics and regulatory related documentation.

• Prepare new and review completed study reports and status updates, including amendments, audits, and other administrative documentation.

• 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.

• 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.

• Assists researchers with protocol development, assembly, and review of clinical trial documents.

• Assists researchers develop and maintain trial related documents and operational procedure.

• Maintains study databases and conducts basic analysis.

• Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.

• 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.

• Develops and assembles clinical trial documents.

• Collects and distributes regulatory documents.

• Develops training plans and trains staff on the proper techniques for protocol submission.

#SOAR

What You Will Need:

• Master’s Degree

• A minimum of TWO (2) years of experience in a clinical trial or clinical research setting. 

• Certification in any of the following: 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), or Certified Clinical Research Associate (CCRA)

• Liaising with regulatory authorities.

• Previous experience in training clinical trial site staff.

• Phases I or II experience and/or regulatory compliance experience.

• Protocol development and protocol navigation knowledge.

• Previous experience with a Clinical Trial Management System (CTMS), Electronic Medical Records System and/or Electronic Data Capture System

What Would Be Nice To Have:

• PhD Degree Preferred

• Familiar with Regulatory affairs and/or IRB submissions

• Strong writing skills with experience writing clinical research protocol.

• Previous experience with the National Institutes of Health (NIH) preferred.

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.