PSI CRO
Contract Research Organization
LeadClinicalResearchAssociate
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“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
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 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
Coordinate project team in process deviations management
Coordinate project team in process deviations reporting
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 closeout visits
Conduct closeout visits
Report closeout visits
Ensure subject recruitment targets defined
Ensure project timelines defined
Ensure subject recruitment targets communicated
Ensure project timelines communicated
Ensure subject recruitment targets recorded
Ensure project timelines recorded
Ensure subject recruitment targets met
Ensure project timelines met
Ensure accurate information flow with trial sites
Ensure timely information flow with trial sites
Ensure Adverse Events information flow
Ensure protocol deviations information flow
Ensure process 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
Supervise Site Management Associates
Supervise flow of documents
Supervise flow of laboratory supplies
Conduct project-specific training of site Investigators
Support preparation of draft regulatory submissions
Support preparation of draft ethics committee submission packages
How You'll Work.
Team & Collaboration
Project team calls; Communication line between roles
Communication Scope
Status updates; Status reports; Training materials; Presentations
Process & Methodology
Project timelines, CAPA development, CAPA implementation
Full Job Description
PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. * Coordinates investigator/ site feasibility and identification process, as well as study startup. * Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. * Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. * Manages Monitors in the query resolution process, including Central Monitoring observations. * Coordinates safety information flow and protocol/process deviation reporting. * Performs clinical supplies management with vendors on a country and regional level. * Ensures study-specific and corporate tracking systems are updated in a timely manner. * Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. * Coordinates planning of supervised monitoring visits and conducts the visits. * Manages the project team in site contracting and payments. * Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. * Ensures ongoing evaluation of data integrity and compliance at a country/regional level. * Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. * Oversees project team in CAPA development and implementation. * Coordinates project team in process deviations review, management and reporting. * Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. * Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Re
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