Project Coordinator – Federal Planning
Michael Baker International
Site ID Specialist, Advanced English
Syneos Health
full-time
Posted on:
Origin: • 🇦🇷 Argentina
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Act as primary contact to the Site Identification Lead for awarded or ongoing trials and possibly pre-award blinded feasibility
- Contribute to local country and site plans (site numbers, types, recruitment rates, competitive studies, challenges)
- Validate feasibility/site ID assessments and prepare final feasibility reports by collecting site-level data
- Collect and QC feasibility survey data and track/document interactions in the Syneos Health Investigator database
- Build local relationships with key research sites and Key Opinion Leaders
- Lead collection/review of historical site/investigator experience data and perform external searches to identify investigators
- Review regulatory sources for investigator actions and document findings for the study team
- Validate and verify site/investigator contact details for final Site/Investigator lists
- Distribute and collect privacy notices, consent forms, confidentiality agreements, questionnaires, and protocol synopses
- Liaise with Site Contract Service Center during site confidentiality agreement negotiations
- Support Site Identification Lead with corrective/preventive actions related to quality issues and communicate compliance/performance
- Ensure submission of site identification documents to the project file and manage study-specific folders per processes
- Contribute to administration/maintenance of global investigator database and assist with clinical systems enhancements as needed
- Serve as back-up for colleagues when required
Requirements
- English Advanced required
- Local knowledge and relationships with research sites and Key Opinion Leaders
- Ability to collect, QC, and document site-level feasibility data
- Experience using investigator databases and clinical data systems
- Ability to perform searches of external data sources to identify investigators
- Ability to review regulatory sources for actions against investigators
- Experience validating and verifying site/investigator contact details
- Ability to distribute and collect site identification documents and liaise during confidentiality agreement negotiations
- Experience supporting corrective and preventive actions (quality/CAPA) and communicating compliance/performance
- Ability to manage study-specific folders and submit documents to collaborative workspace/trial master file
- Willingness to serve as back-up for colleagues
- Equivalent experience, skills, and/or education will be considered
