Clinical Operation Specialist (Sponsor dedicated) - At least 1 year of experience in regulatory and submissions to INVIMA - Bogota, Colombia Client Based at Syneos Health
Clinical Operation Specialist (Sponsor dedicated) - At least 1 year of experience in regulatory and submissions to INVIMA - Bogota, Colombia Client Based
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 Trial Master File (TMF) and project files, including participation 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
May handle receipt, tracking and disposition of Case Report Forms and Queries
Maintains 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
Get to know Syneos Health
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.
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Benefits
Health insuranceVision insurance
Additional Information
Clinical Operation Specialist (Sponsor dedicated) - At least 1 year of experience in regulatory and submissions to INVIMA - Bogota, Colombia Client Based
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health
- 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. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
The position is responsible for providing clerical, administrative, and technical administrative support to one or more business units or clients within Clinical Operations.
Syneos Health · Colombia