[Hiring] Senior Clinical Operations Specialist @Syneos Health

Role Description

Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.

• Assists 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.
• Creates and assists with maintenance of project files, handles project correspondence.
• Participates in file audits.
• Prepares and maintains site manuals, reference tools and other documents.
• Maintains, updates, and inputs clinical tracking information into databases.
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
• Manages shared mailbox, processes site requests and routes correspondence appropriately.
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials.
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items.
• Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues.
• Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.
• May provide training or mentorship to more junior level Clinical Operations Specialists (COS).

Qualifications

• Associates degree preferred or equivalent.
• Experience in clinical research/pharma/biotech or related field considered in lieu of degree.
• Good knowledge of medical terminology, clinical data, and ICH/GCP preferred.
• Ability to successfully prioritize and work on multiple tasks.
• Strong attention to detail, accuracy and organizational skills.
• Excellent communication, presentation, and interpersonal skills.
• Ability to embrace new technologies.
• Minimal travel up to 10% may be required.

Benefits

• 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 building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.