Syneos Health

Intern

Location
Madrid-Calle-Hernani-59, ESP
Salary
Competitive
Posted
23 Jul 2021
Closes
26 Jul 2021
Ref
21008785
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients' lives around the world

Responsabilities
  • Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (60% travel with 75% at peak times) for GCP compliance according to inVentiv Health Clinical SOPs and/or client guidelines
  • Recruit investigators for participation in clinical trials
  • Negotiate study budgets with investigators
  • Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
  • Review draft protocols for completeness and feasibility
  • Develop Case Report Forms for clinical trials
  • Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators' Meetings
  • Prepare and process Serious Adverse Event (SAE) reports
  • Prepare project management reports for clients, project personnel, and inVentiv Health Clinical management
  • Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries
  • Resolve queries of CRF data with study site personnel
  • Review Tables and Listings generated from study data
  • Assist in writing Clinical Study Reports
  • Train junior CRAs on monitoring, internal procedures, and query resolution
  • When allocated by study management, submit essential/required documents to a central IRB or a country's central Ethics Committee, and, if necessary based on local requirements, the Competent Authority
  • Bachelor's Degree or RN
  • Ability and willingness to travel up to 60% with 75% at peak times
  • Excellent organizational skills and ability to manage time and work independently
  • Fluent English
  • Excellent written and verbal communications skills.