PSI CRO
Contract Research Organization
LeadClinicalResearchAssociate
Neural analysis suggests this role is
optimal for mid candidates.
“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 subject recruitment targets are met; Ensure project timelines are met; Ensure data integrity and compliance
Industry & Context.
Query resolution; Problem-solving skills; Risk management
Ability to travel up to 65%, Valid driver’s license
What They're Looking For.
Must Have
Relevant educational background, Minimum of 4 years’ site monitoring experience, Prior experience monitoring or managing sites and CRAs in the United States, Experience with all types of monitoring visits in Phases I-III, Full working proficiency in English, Proficiency in MS Office applications
Nice to Have
Experience in Oncology preferred, Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred, Experience in GI (Chron's, Ulcerative Colitis, IBS) 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
Coordinate safety information flow
Coordinate protocol deviation reporting
Coordinate process deviation reporting
Perform clinical supplies management
Ensure tracking systems are updated
Communicate between Monitor and Site Management Associate
Communicate between Monitor and Regional Project Lead
Communicate between Monitor and Project Manager
Coordinate planning of supervised monitoring visits
Conduct supervised monitoring visits
Manage project team in site contracting
Manage project team in site 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 site 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 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 are defined
Ensure project timelines are defined
Ensure subject recruitment targets are communicated
Ensure project timelines are communicated
Ensure subject recruitment targets are recorded
Ensure project timelines are recorded
Ensure subject recruitment targets are met
Ensure project timelines are met
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 source data verification
Follow up on data queries at site level
Review study risks on a site level
Manage study risks on a site level
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 at site level
Supervise reconciliation of TMF at country level
Ensure data integrity at a site level
Ensure compliance at a site level
Supervise Site Management Associates in document flow
Supervise Site Management Associates in laboratory supplies flow
Conduct project-specific training of site Investigators
Support preparation of draft regulatory submission packages
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; Reports; Training delivery; Presentations
Process & Methodology
Project timelines, Patient enrollment monitoring, Corrective measures, Preventive measures, Tracking systems, CAPA development, Process deviations review
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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