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Clinical Research Compliance Specialist
2 months ago
Job Family:
Clinical Trial Operations (Digital)
Travel Required:
Clearance Required:
Key Responsibilities:
We are seeking a Clinical Research Protocol Navigator to provide essential regulatory support for clinical research initiatives. This position focuses on the development of clinical research protocols and informed consent documents, necessitating exceptional writing capabilities. Responsibilities include managing IRB submissions and overseeing regulatory documentation.
- Draft and evaluate new and modified clinical research protocols and associated documents throughout the study lifecycle, ensuring accuracy and thoroughness.
- Create and assess informed consent forms and other ethics-related documentation.
- Compile and review study reports and updates, including amendments and audits.
- Prepare and review IND and IDE safety reports and regulatory communications.
- Maintain comprehensive regulatory trial documentation, including a current Regulatory Binder for each trial.
- Assist researchers in developing internal proposals, abstracts, presentations, and manuscript drafts.
- Collaborate with the Clinical Trials Unit and other stakeholders to establish standard operating procedures related to protocol navigation and regulatory writing.
- Coordinate with various offices to ensure the consistency of revised documents with established policies.
- Work alongside clinical research scientists, Principal Investigators, and other key personnel to facilitate effective communication and collaboration.
- Prepare safety reports and other regulatory correspondences, ensuring compliance with IRB processes.
- Maintain organized records of all protocols, safety reports, and correspondence.
- Write and edit necessary study documentation, including protocols and amendments.
- Track adverse event files and prepare relevant reports.
Qualifications:
- Master’s Degree in relevant fields such as Health Sciences, Nursing, Biology, or related disciplines.
- Minimum of two years of experience in a clinical trial or research environment.
- Experience liaising with regulatory bodies and training clinical trial staff.
- Familiarity with Phases I or II trials, regulatory compliance, and protocol development.
- Previous involvement with regulatory affairs and IRB submissions.
- Strong writing skills with a background in drafting clinical research protocols.
- Proficiency in Clinical Trial Management Systems and Electronic Medical Records.
Preferred Qualifications:
- PhD Degree.
- Relevant certifications such as ACRP-CP, CCRP, CCRC, or CCRA.
Benefits:
Guidehouse offers a comprehensive rewards package that includes competitive compensation and a flexible benefits program, reflecting our commitment to a diverse and supportive workplace.
- 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 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.
