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Clinical Research Compliance Specialist
2 months ago
Job Family:
Clinical Trial Operations (Digital)
Travel Required:
Clearance Required:
Position 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 of clinical research protocols and informed consent documents, requiring exceptional writing capabilities. Responsibilities include managing IRB submissions and regulatory documentation, among other critical tasks. This is a full-time position.
- Create and assess new and revised clinical research protocols and associated documentation throughout the study lifecycle, ensuring accuracy and completeness.
- Draft and evaluate informed consent forms and other ethical and regulatory documents.
- Generate and review study reports and updates, including amendments and audit documentation.
- Prepare IND and IDE safety reports and other regulatory communications, including initial submissions and annual updates.
- Maintain comprehensive regulatory trial documentation, including an up-to-date Regulatory Binder for each trial.
- Assist researchers in developing internal research proposals, abstracts, poster presentations, and manuscript drafts.
- Collaborate with the NINDS CTU and staff to establish standard operating procedures (SOPs) related to protocol navigation and regulatory writing.
- Coordinate with various offices to ensure consistency and compliance of documents with established policies.
- Work alongside NIH clinical research scientists, Principal Investigators, and other stakeholders to facilitate effective communication and collaboration.
- Track and review adverse event files, preparing reports in accordance with Institutional Review Board (IRB) policies.
Qualifications:
- Master’s Degree in relevant fields such as Health Medical Professions, Nursing, Biology, Neuroscience, or related disciplines.
- Minimum of two years of experience in a clinical trial or research environment.
- Experience liaising with regulatory authorities and training clinical trial site personnel.
- Familiarity with Phases I or II clinical trials, regulatory compliance, and protocol development.
- Strong writing skills with a proven track record in drafting clinical research protocols.
- Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Medical Records.
Preferred Qualifications:
- PhD Degree in a relevant field.
- Certification from recognized clinical research organizations is advantageous.
What We Offer:
Guidehouse provides a comprehensive rewards package that includes competitive compensation and a flexible benefits program, reflecting our commitment to 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 and Flexible Spending Accounts
- Transit and Parking Commuter Benefits
- Short-Term & Long-Term Disability
- Tuition Reimbursement and Learning Opportunities
- Employee Referral Program
- Corporate Sponsored Events & Community Outreach
- Employee Assistance Program
About Guidehouse:
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to any protected status.
