Regulatory Operations Specialist
hace 3 semanas
Syneos Health, Inc. is seeking a highly skilled Regulatory Operations Specialist to join their team. As a key member of the Clinical Operations department, you will be responsible for ensuring compliance with regulatory requirements and policies.
Key Responsibilities- Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions.
- Assist Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures, and relevant guidelines.
- Create and assist with maintenance of Trial Master File (TMF) and project files, including participation in file audits.
- Prepare and maintain site manuals, reference tools, and other documents.
- Maintain, update, and input clinical tracking information into databases.
- Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
- Manage shared mailbox, process site requests, and route correspondence appropriately.
- Coordinate the ordering, packaging, shipping, and tracking of site supplies and materials.
- Assist with coordination of team meetings, attend meetings, and prepare accurate meeting minutes and action items.
- High School diploma or equivalent.
- Good communication and interpersonal skills.
- Ability to embrace new technologies.
- Minimal travel up to 25% may be required.
Over the past 5 years, Syneos Health, Inc. has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. We are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.
CompensationThe estimated salary range for this position is $65,000 - $90,000 per year, depending on location and experience. We offer a competitive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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