Senior Specialist, Regulatory Operations
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Job Description
Senior Specialist leading regulatory operations for clinical trials at Care Access. Ensuring compliance with U.S. regulations and supporting site-level activities in a remote role.
Responsibilities:
- Provide regulatory advice, lead, execute and deliver regulatory project work
- Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, OHRP and global regulatory standards.
- Assist in preparing for sponsor monitoring visits and follow up requirements.
- Develop and implement regulatory strategies to support sites activities
- Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices.
- Coordinates preparation and review of key site essential records.
- Track essential records and timelines
- Support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout.
- Actively work towards KPIs to help ensure departmental success
- Supports creation and maintenance of study Delegation of Authority (DOA) logs
- Support regulatory activities throughout the duration of the study lifecycle; collaborating with clinical operations teams to ensure regulatory compliance
Requirements:
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience.
- Minimum of 4 years of experience in operational regulatory affairs within the research site (preferable), or CRO/pharmaceutical industry, with a focus on U.S. regulatory requirements.
- Strong understanding of U.S. regulations and ICH GCP guideline as they relate to site operations
- Excellent knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in the U.S.
- Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance.
Benefits:
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
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