PSI CRO
Healthcare
LeadClinicalResearchAssociate
Neural analysis suggests this role is
optimal for mid candidates.
“Lead Clinical Research Associate at PSI CRO. Skills: Clinical trial oversight, Team leadership, Compliance monitoring. Monitor project timelines. Monitor patient enrollment”
What You'll Achieve.
Ensure high-quality execution; Ensure compliance; Ensure timely delivery; Ensure reporting compliance; Ensure data integrity; Ensure compliance at site level; Ensure Investigational Product handling; Ensure Investigational Product use; Ensure Investigational Product accountability; Ensure Investigational Product reconciliation; Ensure Investigational Product return; Ensure ongoing evaluation of data integrity; Ensure ongoing evaluation of compliance; Ensure subject recruitment targets met; Ensure project timelines met; Ensure accurate information flow; Ensure timely information flow
Industry & Context.
Corrective measures; Preventive measures; Data cleaning; Data queries; Study risks; Query resolution; Process deviations; Audit findings resolution; CAPA development; CAPA implementation
Ability to travel, Valid driver’s license
What They're Looking For.
Must Have
4 years site monitoring experience, Experience with all visit types, Full working proficiency in English, Proficiency in MS Office applications, Ability to plan, multitask, Ability to travel, Valid driver’s license
Nice to Have
Experience in Oncology preferred, Experience in Radiation Therapy, Experience in CAR-T Therapy, Experience in Gene Therapy, Experience in Nuclear Medicine, Experience in GI preferred
What You'll Do.
Monitor project timelines
Monitor patient enrollment
Monitor data cleaning
Implement corrective measures
Implement preventive measures
Review monitoring visit reports
Ensure reporting compliance
Act as communication line
Lead project team calls
Provide status updates
Provide project-specific training
Prepare training materials
Supervise source data verification
Follow up on data queries
Ensure Investigational Product handling
Ensure Investigational Product use
Ensure Investigational Product accountability
Ensure Investigational Product reconciliation
Ensure Investigational Product return
Review essential study documents
Supervise study document reconciliation
Supervise ISF reconciliation
Supervise TMF reconciliation
Ensure data integrity
Ensure compliance at site level
Collaborate with investigator feasibility
Collaborate with site identification
Collaborate with study startup
Manage Monitors in query resolution
Manage Monitors in Central Monitoring
Coordinate safety information flow
Coordinate protocol deviation reporting
Coordinate process deviation reporting
Perform clinical supplies management
Ensure tracking systems updated
Coordinate planning of supervised visits
Conduct supervised monitoring visits
Manage project team in contracting
Manage project team in payments
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 new CRAs
Deliver trainings at Investigator Meetings
Deliver presentations at Investigator Meetings
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 SMAs in document flow
Supervise SMAs in lab supplies flow
Support preparation of regulatory submissions
Support preparation of ethics committee submissions
How You'll Work.
Team & Collaboration
Cross-functional teams; Study team; Regional project lead; Project manager
Communication Scope
Status updates; Reports
Process & Methodology
Project timelines, Project team management, Project planning
Full Job Description
PSI is a leading Contract Research Organization with more than 25 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. As a Lead Clinical Research Associate, you will hold a leadership role within the study team, overseeing and guiding the clinical team while driving trial activities at a country or regional level. You will ensure high-quality execution, compliance, and timely delivery. You will act as a key point of coordination across cross-functional teams. 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. Responsibilities: * Monitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures. * Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. * Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. * Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. * Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. * Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. * Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. * Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / T
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