Clinical Operations Specialist Focus Regulatory
hace 1 semana
**About the Role**
Syneos Health Clinical is seeking a Clinical Operations Specialist to focus on regulatory activities for our Mexico Client Based team.
As a Clinical Operations Specialist, you will be responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions.
**Key Responsibilities**
- 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.
- May handle receipt, tracking, and disposition of Case Report Forms and Queries.
- Maintain overall awareness in the field of clinical research by completing all necessary and assigned training.
**Requirements**
- High School diploma or equivalent.
- Good communication and interpersonal skills.
- Ability to embrace new technologies.
- Minimal travel up to 25% may be required.
**About Syneos Health Clinical**
Over the past 5 years, we have 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 a highly competitive and ever-changing environment, and 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.
We are committed to our Total Self culture, where you can authentically be yourself, and we are dedicated to taking care of our people.
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