PSI CRO
Healthcare
LeadClinicalResearchAssociate
“Lead Clinical Research Associate at PSI CRO. Skills: Clinical research, Oversight, Compliance. Monitor project timelines. Monitor patient enrollment”
What You'll Achieve.
Ensure high-quality execution; Ensure compliance; Ensure timely delivery
Industry & Context.
Problem-solving skills
Ability to travel, Valid driver’s license
What They're Looking For.
Must Have
4 years site monitoring experience, Experience with all visit types, Full working proficiency in English, Proficiency in MS Office applications
Nice to Have
Experience in Oncology preferred, Experience in Radiation Therapy preferred, Experience in CAR-T Therapy preferred, Experience in Gene Therapy preferred, Experience in Nuclear Medicine preferred, Experience in GI preferred
What You'll Do.
Monitor project timelines
Monitor patient enrollment
Monitor data cleaning
Implement corrective measures
Implement preventive measures
Review monitoring visit reports
Ensure reporting compliance
Lead project team calls
Provide status updates
Provide project-specific training
Prepare training materials
Supervise source data verification
Follow up on data queries
Ensure proper handling of Investigational Product
Ensure use of Investigational Product
Ensure accountability of Investigational Product
Ensure reconciliation of Investigational Product
Ensure return of Investigational Product
Review essential study documents
Supervise reconciliation of study Investigator Site File
Supervise reconciliation of TMF
Ensure data integrity
Ensure compliance at site level
Collaborate with investigator feasibility
Collaborate with site identification
Collaborate with study startup
Manage Monitors in query resolution
Manage Central Monitoring observations
Coordinate safety information flow
Coordinate protocol deviation reporting
Coordinate process deviation reporting
Perform clinical supplies management
Update tracking systems
Coordinate planning of supervised monitoring visits
Conduct supervised monitoring visits
Manage project team in site contracting
Manage project team in site payments
Evaluate data integrity
Conduct site audit preparation visits
Participate in site audits
Coordinate resolution of site audit findings
Oversee project team in CAPA development
Oversee project team in CAPA implementation
Coordinate project team in process deviations review
Coordinate project team in process deviations management
Coordinate project team in process deviations reporting
Conduct initial training monitoring visits
Conduct authorization monitoring visits
Act as mentor for newly promoted Lead CRAs
Deliver trainings at Investigator Meetings
Deliver presentations at Investigator Meetings
Define subject recruitment targets
Define project timelines
Communicate subject recruitment targets
Communicate project timelines
Record subject recruitment targets
Record project timelines
Meet subject recruitment targets
Meet project timelines
Ensure accurate information flow with trial sites
Ensure timely information flow with trial sites
Ensure accurate information flow on Adverse Events
Ensure timely information flow on Adverse Events
Ensure accurate information flow on protocol deviations
Ensure timely information flow on protocol deviations
Ensure accurate information flow on process deviations
Ensure timely information flow on process deviations
Supervise SMAs in document flow
Supervise SMAs in laboratory supplies flow
Support preparation of regulatory submission packages
Support preparation of ethics committee submission packages
How You'll Work.
Team & Collaboration
Cross-functional teams; Study team
Communication Scope
Status updates; Reports
Process & Methodology
Project timelines, Project management
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