Job Family:
Clinical Trial Operations (Digital)
Travel Required:
Clearance Required:
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.
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- 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.
- Assist researchers with protocol development, assembly, maintenance, and review of clinical trial documents and operational procedures.
- Maintain study databases and conduct basic analysis.
- Assist researchers collect, distribute and file regulatory documents.
- 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.
- 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.
- Collect, distribute, file, and submit regulatory documents.
- Review and maintain trial related documents and operational procedures.
- Develop training plans and train staff on the proper techniques for protocol submission.
What You Will Need:
- Master’s Degree
- At least THREE (3) years of experience with clinical trials
- Familiar with using electronic systems
What Would Be Nice To Have:
- Preferred areas of study are nursing, biology, general science, general medical and health services, or similar disciplines.
- 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)
- Liaising with regulatory authorities
- Training clinical trial site staff
- Clinical Trial Phase I or II experience.
- Regulatory compliance & regulatory affairs
- Protocol development & navigation
- Clinical Research & Data Integrity
- IRB submissions
- On-site visits
- Strong writing skills with experience writing clinical research protocols.
- Clinical Trial Management System (CTMS)
- Electronic Medical Records System (EMR)
- Electronic Data Capture System
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.