Clinical Trials Coordinator
hace 2 días
About Syneos Health
Syneos Health is a leading biopharmaceutical solutions organization, dedicated to accelerating customer success. We harness unique clinical, medical affairs, and commercial insights to drive outcomes in modern markets.
Our Clinical Development model puts the customer and patient at its core, simplifying and streamlining our work to make us easier to work with and for.
We collaborate with passionate problem solvers to innovate and help customers achieve their goals, driving therapy delivery and changing lives.
Career Development Opportunities
We are committed to developing our people through career development, progression, line management support, technical and therapeutic area training, peer recognition, and total rewards programs.
Job Responsibilities:
Quality Deliverables: Responsible for delivering high-quality country-level results; follows project requirements and applicable country rules, with moderate oversight from the Country Manager.
Project Timelines: Works within forecasted submission/approval timelines and ensures compliance; tracks milestone progress in real-time; investigates delays, provides clear rationale, and escalates issues promptly.
Financial Aspects: Monitors basic financial aspects of the project and contract hours/tasks; escalates discrepancies timely.
Standard Operating Procedures: Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI); keeps training records updated and ensures timesheet compliance.
Site Activation: Supports quality improvement in Site Start-Up components at the country level, ensuring relevant documents are submitted to the Trial Master File as per Company SOP/Sponsor requirements.
Local Submissions Specialist: Follows project direction provided by the designated start-up advisor and collaborates with PM/SAL; prepares and submits local regulatory applications and submissions as required.
Ongoing Submissions: Prepares ongoing submissions, amendments, and periodic notifications for central and local EC and RA as needed; includes safety notifications according to local rules.
Site ID and Feasibility Support: Collaborates with site selection lead and PM/SAL to select appropriate sites based on trial requirements.
Local Investigator Contract and Budget Negotiator: Supports negotiations with site via Site Contracts Service Centre and Sponsor until resolution and contract execution.
Requirements:
• Bachelor's Degree
• Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
Compensation: $70,000 - $90,000 per year.
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