Lead Clinical Research Associate
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Job Description
Lead clinical research trials for PSI, a contract research organization, across Peru and regional teams. Oversee monitors, compliance, data integrity, training, audits, and study delivery remotely.
Responsibilities:
- Oversee and guide the clinical team while driving trial activities at country or regional level
- Monitor project timelines, patient enrollment, data cleaning, compliance, and corrective and preventive measures
- Review monitoring visit reports and ensure regional reporting compliance
- Coordinate communication among Monitors, Site Management Associates, Regional Project Leads, and Project Managers
- Lead country-level project team calls and provide status updates and reports
- Provide project-specific training and prepare training materials
- Supervise source data verification, data-query follow-up, and site-level study-risk management
- Ensure proper handling, accountability, reconciliation, and return of investigational products and clinical study supplies
- Review essential study documents and supervise reconciliation of Investigator Site Files and TMF
- Ensure site-level data integrity and compliance
- Support investigator/site feasibility, identification, and study startup
- Manage Monitors in query resolution, including Central Monitoring observations
- Coordinate safety-information flow and protocol/process-deviation reporting
- Manage clinical supplies with vendors at country and regional levels
- Maintain study-specific and corporate tracking systems
- Coordinate supervised monitoring visits and conduct visits
- Manage site contracting and payments
- Evaluate data integrity and compliance at country/regional level
- Prepare for and participate in site audits and coordinate resolution of findings
- Oversee CAPA development and implementation
- Coordinate process-deviation review, management, and reporting
- Conduct initial training and authorization monitoring visits for Monitors
- Mentor newly promoted Lead CRAs
- Deliver trainings and presentations at Investigator Meetings
- Ensure subject recruitment targets and project timelines are defined, communicated, recorded, and met
- Ensure timely information flow with trial sites regarding Adverse Events and protocol/process deviations
- Supervise Site Management Associates handling documents and laboratory supplies
- Support preparation of regulatory and ethics committee submission packages
Requirements:
- Relevant educational background such as MD, MPharm, RN, or a college/university degree in Life Sciences, or equivalent combination of education, training, and experience
- Minimum 4 years of site monitoring experience
- Participation in global clinical projects as a Lead Monitor or equivalent qualification level
- Experience monitoring sites in the US
- Experience with all types of monitoring visits in Phase II and/or III
- Strong Oncology experience preferred
- Experience in Radiation Therapy, Radiopharmaceuticals, CAR-T Therapy, other Cell Therapy, Gene Therapy, or Nuclear Medicine preferred
- Strong experience in GI, including Crohn's, Ulcerative Colitis, or IBS, preferred
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan and multitask in a dynamic team environment
- Excellent communication, collaboration, and problem-solving skills
- Ability to travel
Benefits:
- Remote work
- Career growth opportunities
- Opportunity to coordinate a variety of tasks and learn new things
- People-first company culture
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