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

• Coordinate investigator/site feasibility, identification, and study startup • Monitor project timelines and patient enrollment, implementing corrective and preventive measures • Review monitoring visit reports and ensure regional Monitor reporting compliance • Manage Monitor 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 • Act as the main communication line between Monitors, Site Management Associates, Regional Project Leads, and Project Managers • Coordinate supervised monitoring visits and conduct visits • Manage site contracting and payments • Lead country-level project team calls and provide status updates and reports • Evaluate data integrity and compliance at country, regional, and site levels • Conduct site audit preparation visits, 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 • Prepare and deliver project-specific training and Investigator Meeting presentations • Prepare, conduct, and report site selection, initiation, routine monitoring, and closeout visits • 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 source data verification and follow up on site-level data queries • Review and manage site-level study risks • Ensure proper handling, accountability, reconciliation, and return of Investigational Products and clinical study supplies • Review essential study documents and supervise ISF/TMF reconciliation • Supervise document and laboratory supply flow between sites and central/regional laboratories or reviewers • Conduct project-specific training for site Investigators • 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 an equivalent combination of education, training, and experience • Minimum 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level • Prior experience monitoring or managing sites and CRAs • Knowledge of US and Canadian regulatory guidelines and practices • Experience with Phase I–III monitoring visits • Strong Oncology experience preferred • Experience in CAR-T Therapy, Cell Therapy, Gene Therapy, Radiation Therapy, Radiopharmaceuticals, or Nuclear Medicine preferred • Strong GI experience, 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 up to 65%, depending on project needs • Valid driver’s license, if applicable • Must not require work visa sponsorship now or in the future

🏖️ Benefits

• Remote work option • Career growth opportunities • Opportunity to learn new things • Work with a company that puts its people first