Lead Clinical Research Associate

🔥 0 minutes ago

🇺🇸 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 • Focus on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model • 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 and reports • Provide project-specific training and prepare training materials • Supervise source data verification, follow up on data queries, and manage study risks at site level • Ensure proper handling, accountability, reconciliation, and return of Investigational Products and clinical study supplies • Review essential study documents and supervise reconciliation of ISF/TMF files • Ensure data integrity and compliance at site and country/regional levels • 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 • Manage clinical supplies with vendors at country and regional levels • Maintain study-specific and corporate tracking systems • Coordinate and conduct supervised monitoring visits • Manage site contracting and payments • 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 handling documents and laboratory supplies • Support preparation of regulatory and ethics committee submission packages

🎯 Requirements

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience • Minimum of 4 years’ site monitoring experience with 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 experience in Oncology preferred • Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, or Nuclear Medicine preferred • Strong experience in GI (Chron's, Ulcerative Colitis, 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) • PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future

🏖️ Benefits

• A stable, privately held CRO that has never undergone a merger or acquisition and has never experienced company-wide layoffs • A unique leadership-focused CRA role with minimal travel and little to no routine site assignments • Opportunities to mentor other CRAs and expand your leadership skills • A collaborative, people-first culture where employees are genuinely supported • Career development opportunities across a growing global organization • The chance to contribute to innovative clinical research that improves patients' lives