Lead Clinical Research Associate

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• 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