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

• Provide leadership, oversight, and mentorship across regional clinical trials • Partner with Project Managers, Regional Project Leads, CRAs, and cross-functional teams to ensure high-quality study execution • Monitor project timelines, patient enrollment, data cleaning, and compliance; implement corrective and preventive measures • Review monitoring visit reports and ensure regional reporting compliance • Act as the main communication line among Monitors, Site Management Associates, Regional Project Leads, and Project Managers • Lead country-level project team calls and provide status updates to Regional Leads and Project Managers • 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 ISF/TMF reconciliation • Ensure site-level data integrity and compliance • Collaborate on investigator/site feasibility, identification, and study startup • Manage query resolution, including Central Monitoring observations • Coordinate safety-information flow and protocol/process-deviation reporting • Conduct clinical supplies management 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 • Conduct audit preparation visits, participate in site audits, and coordinate resolution of audit 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 accurate and timely information flow with trial sites regarding Adverse Events and protocol/process deviations • Supervise Site Management Associates in document and laboratory-supply flows • 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’ site monitoring experience • Participation in global clinical projects as a Lead Monitor or equivalent qualification level • Experience with all types of monitoring visits in Phase II and/or III • Strong Oncology experience preferred • Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other Cell Therapy, Gene Therapy, 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, multitask, and work in a dynamic team environment • Excellent communication, collaboration, and problem-solving skills • Ability to travel • Valid driver’s license, if applicable • Must not require a work visa for employment or continued employment now or in the future

🏖️ Benefits

• Stable, privately held CRO with no mergers, acquisitions, or company-wide layoffs • Unique leadership-focused CRA role with minimal travel and little to no routine site assignments • Opportunities to mentor other CRAs and expand leadership skills • Collaborative, people-first culture • Career development opportunities across a growing global organization • Opportunity to contribute to innovative clinical research that improves patients' lives