PSI CRO
Pharmaceuticals
ClinicalTrialsLeadSiteCoordinator
“Clinical Trials Lead Site Coordinator at PSI CRO. Skills: Site coordination, Clinical trials, Sponsor communication. Act as main line of communication. Ensure response to feasibility questions”
What You'll Achieve.
Meet project timelines; Meet enrollment goals
Industry & Context.
Problem-solve in an effective manner; Problem-solve in an efficient manner
Flexibility in working hours
What They're Looking For.
Must Have
College or university degree, Minimum of 2 years of on-the-job experience in a clinical trial environment, Relevant experience in clinical trials, Relevant experience in clinical terminology, Relevant experience in medical research, Experience in the role of a Study Coordinator or similar function, Upper-intermediate level of English
Nice to Have
Experience in Oncology, Experience in Renal, Experience in Cardiology clinical studies, Interest in professional growth and development
What You'll Do.
Act as main line of communication
Ensure response to feasibility questions
Assist in scheduling monitoring visits
Assist in preparation for monitoring visits
Be present during monitoring visits
Respond to monitors during visits
Track patient enrollment
Support meeting project timelines
Support meeting enrollment goals
Maintain study specific tracking of documents
Maintain general tracking of documents
Accurate data entry into EDC systems
Timely resolution of data clarification queries
Timely reporting on Reportable Adverse Events
Timely reporting on Protocol Deviations
Follow up on Reportable Adverse Events
Follow up on Protocol Deviations
Proper handling of investigational products
Proper handling of clinical supplies
Accountability of investigational products
Accountability of clinical supplies
Reconciliation of investigational products
Reconciliation of clinical supplies
Collect site-specific regulatory documents
Handle site-specific regulatory documents
Maintain site-specific regulatory documents
Facilitate contract negotiations
Facilitate budget negotiations
Support Investigator payments
Support Site payments
Support Investigator processes
Support Site processes
Schedule study procedures
Perform study procedures
Prepare for onsite study audits
Participate in onsite study audits
Prepare for regulatory agency inspections
Participate in regulatory agency inspections
Build relationships with clients
Sustain relationships with clients
How You'll Work.
Team & Collaboration
Global team environment; Site and CRO/Sponsor team
Communication Scope
Feasibility questions; Monitoring visits; Enrollment goals
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