PSI CRO
Contract Research Organization
LeadClinicalResearchAssociate
“Lead Clinical Research Associate at PSI CRO. Skills: Clinical research monitoring, Site management, Project coordination. Coordinate investigator/site feasibility. Coordinate study startup”
What You'll Achieve.
Ensure reporting compliance; Ensure tracking systems updated; Ensure data integrity and compliance; Ensure subject recruitment targets met; Ensure project timelines met; Ensure accurate information flow; Ensure timely information flow; Ensure proper handling of supplies; Ensure data integrity at site level; Ensure compliance at site level
Industry & Context.
Problem-solving skills; Query resolution; Corrective measures; Preventive measures; Risk management
Ability to travel up to 65%, Valid driver’s license
What They're Looking For.
Must Have
4 years site monitoring experience, Experience monitoring/managing sites and CRAs in US, Knowledge of US regulatory guidelines, Experience with all monitoring visit types, Full working proficiency in English, Proficiency in MS Office applications
Nice to Have
Experience in Oncology preferred, Experience in CAR-T Therapy preferred, Experience in Cell Therapy preferred, Experience in Gene Therapy preferred, Experience in Radiation Therapy preferred, Experience in Nuclear Medicine preferred, Experience in GI preferred
What You'll Do.
Coordinate investigator/site feasibility
Coordinate study startup
Monitor project timelines
Monitor patient enrollment
Implement corrective measures
Implement preventive measures
Review monitoring visit reports
Ensure reporting compliance
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
Ensure tracking systems updated
Act as communication line
Coordinate supervised monitoring visits
Conduct monitoring visits
Manage project team in contracting
Manage project team in payments
Lead project team calls
Provide status updates
Provide reports to Regional Lead
Provide reports to Project Manager
Ensure ongoing evaluation of data integrity
Ensure ongoing evaluation of compliance
Conduct site audit preparation visits
Participate in site audits
Coordinate resolution of audit findings
Oversee project team in CAPA development
Oversee project team in CAPA implementation
Conduct initial training visits
Conduct authorization monitoring visits
Act as mentor for CRAs
Provide project-specific training
Prepare training materials
Deliver trainings at Investigator Meetings
Deliver presentations at Investigator Meetings
Prepare site selection visits
Conduct site selection visits
Report site selection visits
Prepare site initiation visits
Conduct site initiation visits
Report site initiation visits
Prepare routine monitoring visits
Conduct routine monitoring visits
Report routine monitoring visits
Prepare site closeout visits
Conduct site closeout visits
Report site closeout visits
Ensure subject recruitment targets defined
Ensure project timelines defined
Communicate recruitment targets
Communicate project timelines
Record recruitment targets
Record project timelines
Meet recruitment targets
Meet project timelines
Ensure accurate information flow
Ensure timely information flow
Supervise source data verification
Follow up on data queries
Ensure proper handling of Investigational Product
Ensure proper use of Investigational Product
Ensure proper accountability of Investigational Product
Ensure proper reconciliation of Investigational Product
Ensure proper return of Investigational Product
Ensure proper handling of clinical study supplies
Review essential study documents
Supervise reconciliation of Investigator Site File
Supervise reconciliation of TMF
Ensure data integrity at site level
Ensure compliance at site level
Supervise Site Management Associates
Supervise flow of documents
Supervise flow of laboratory supplies
Conduct project-specific training of Investigators
How You'll Work.
Team & Collaboration
Communication line between roles; Project team calls; Cross-functional teams
Communication Scope
Status updates; Reports; Training delivery; Presentations
Process & Methodology
Project timelines, Patient enrollment, CAPA development, CAPA implementation
Applying for this Lead Clinical Research Associate role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on SmartRecruiters
- SmartRecruiters often includes a video screening step — check camera and mic permissions.
- Link your GitHub or portfolio directly in the profile section for technical roles.
- Applications may be reviewed by AI scoring before reaching a recruiter — use keywords from the job description.
ANONYMOUS · UNFILTERED
What do employees actually say about PSI CRO?
Real rants from real employees. Read before you apply.