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.