PSI CRO
Pharmaceuticals
LeadClinicalResearchAssociate
Neural analysis suggests this role is
optimal for mid candidates.
“Lead Clinical Research Associate at PSI CRO. Skills: Clinical research, Monitoring oversight, Team leadership. Coordinate investigator/ site feasibility and identification. Coordinate study startup”
What You'll Achieve.
Ensure reporting compliance of Monitors; Ensure study-specific and corporate tracking systems are updated; Ensure ongoing evaluation of data integrity and compliance; Ensure data integrity and compliance at a site level; Ensure subject recruitment targets and project timelines are met
Industry & Context.
Corrective and preventive measures; Query resolution; CAPA development and implementation; Process deviations review, management and reporting; Site audit findings resolution; Study risks review and management
Travel up to 65%, Valid driver’s license, No work visa required
What They're Looking For.
Must Have
Relevant educational background, Minimum of 4 years’ site monitoring experience, Experience monitoring or managing sites and CRAs in the United States, Knowledge of US regulatory guidelines and practices, Experience with all types of monitoring visits in Phases I-III, Full working proficiency in English, Proficiency in MS Office applications, Ability to plan, multitask and work in a dynamic team environment, Ability to travel up to 65%
Nice to Have
Experience in Oncology, Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine, Experience in GI (Chron's, Ulcerative Colitis, IBS)
What You'll Do.
Coordinate investigator/ site feasibility and identification
Coordinate study startup
Monitor project timelines
Monitor patient enrollment
Implement corrective and preventive measures
Review monitoring visit reports
Ensure reporting compliance
Manage Monitors in query resolution
Manage Central Monitoring observations
Coordinate safety information flow
Coordinate protocol/ process deviation reporting
Perform clinical supplies management with vendors
Ensure study-specific and corporate tracking systems are updated
Act as main communication line
Coordinate planning of supervised monitoring visits
Conduct supervised monitoring visits
Manage project team in site contracting
Manage project team in payments
Lead project team calls
Provide status updates and 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 and authorization monitoring visits for
Act as mentor for newly promoted Lead CRAs
Provide project-specific training
Prepare training materials for project team
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 and timely information flow with trial
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 (ISF)
Supervise reconciliation of TMF at site level
Supervise reconciliation of study Investigator Site File (ISF)
Supervise reconciliation of TMF at country/region level
Ensure data integrity at a site level
Ensure compliance at a site level
Supervise Site Management Associates in flow of documents
Supervise Site Management Associates in flow of laboratory
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
Communication line between Monitor, Site Management Associate, Regional Project Lead, and Project Manager; Lead project team calls; Provide status updates and reports to Regional Lead/ Project Manager; Oversee project team in CAPA development and implementation; Coordinate project team in process deviations review, management and reporting; Provide project-specific training and prepare training materials for the project team; Supervise Site Management Associates
Communication Scope
Communication line; Status updates; Reports; Trainings; Presentations
Process & Methodology
Monitor project timelines, Monitor patient enrollment, Implement corrective and preventive measures, Manage project team, Coordinate planning, Ensure tracking systems are updated, CAPA development and implementation, Process deviations review, management and reporting, Ensure subject recruitment targets and project timelines are defined, communicated, recorded, and met
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. This role focuses on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model, emphasizing remote oversight and overall study quality. * 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 init
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