Lead Clinical Research Associate

🕒 August 10

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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, compliance, and 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 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 ISF/TMF reconciliation • Ensure site-level data integrity and compliance • Collaborate on 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 • Perform clinical supplies management with vendors • 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 • Conduct 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 • 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 on Adverse Events and protocol/process deviations • Supervise Site Management Associates in document and laboratory-supply flow • 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 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

• Minimal travel and little to no routine site assignments • Collaborative, people-first culture where employees are genuinely supported • Career development opportunities across a growing global organization • Opportunities to mentor other CRAs and expand leadership skills • Stable, privately held CRO with no merger or acquisition and no company-wide layoffs • Opportunity to contribute to innovative clinical research that improves patients' lives