PSI CRO
Contract Research Organization
LeadClinicalResearchAssociate
“Lead Clinical Research Associate at PSI CRO. Skills: Clinical research, Site management, Regulatory compliance. Coordinate investigator/site feasibility. Coordinate study startup”
What You'll Achieve.
Ensure subject recruitment targets met; Ensure project timelines met
Industry & Context.
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 visits Phases I-III, Full working proficiency in English, Proficiency in MS Office applications
Nice to Have
Experience in Oncology, Experience in CAR-T Therapy, Experience in Cell Therapy, Experience in Gene Therapy, Experience in Radiation Therapy, Experience in Radiopharmaceuticals, Experience in Nuclear Medicine, Experience in GI, Experience in Chron's, Experience in Ulcerative Colitis, Experience in IBS
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
Coordinate safety information flow
Coordinate protocol deviation reporting
Coordinate process deviation reporting
Perform clinical supplies management
Ensure tracking systems updated
Communicate between Monitor and Site Management Associate
Communicate between Monitor and Regional Project Lead
Communicate between Monitor and Project Manager
Coordinate supervised monitoring visits
Conduct monitoring visits
Manage project team in site contracting
Manage project team in site payments
Lead project team calls
Provide status updates
Provide status reports
Ensure ongoing evaluation of data integrity
Ensure ongoing evaluation of compliance
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
Conduct initial training visits
Conduct authorization monitoring visits
Act as mentor for newly promoted Lead 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 with trial sites
Ensure timely information flow with trial sites
Ensure Adverse Events information flow
Ensure protocol deviations information flow
Supervise source data verification
Follow up on data queries
Ensure proper handling of Investigational Product(s)
Ensure proper use of Investigational Product(s)
Ensure proper accountability of Investigational Product(s)
Ensure proper reconciliation of Investigational Product(s)
Ensure proper return of Investigational Product(s)
Ensure proper handling of clinical study supplies
Ensure proper use of clinical study supplies
Ensure proper accountability of clinical study supplies
Ensure proper reconciliation of clinical study supplies
Ensure proper return of clinical study supplies
Review essential study documents
Supervise reconciliation of study Investigator Site File
Supervise reconciliation of TMF
Ensure data integrity at site level
Ensure compliance at site level
Supervise flow of documents
Supervise flow of laboratory supplies
Conduct project-specific training of site Investigators
How You'll Work.
Team & Collaboration
Project team calls; Communication line
Communication Scope
Status updates; Status reports; Training materials; Trainings; Presentations
Process & Methodology
Project timelines, CAPA development
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