Lead Clinical Research Associate in United States at Jobgether
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Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Lead Clinical Research Associate in the United States.
This role is a senior-level leadership position within global clinical trial operations, focused on ensuring high-quality execution and compliance across multiple studies at a country or regional level. You will act as a key coordinator between clinical monitors, project managers, and site-facing teams, driving consistency in monitoring practices and operational excellence. Rather than focusing primarily on direct site visits, this position emphasizes oversight, governance, and quality assurance across ongoing trials. You will play a critical role in ensuring data integrity, patient safety, and adherence to regulatory standards. The environment is highly collaborative, working across cross-functional clinical teams in a fast-paced research setting. This role also includes mentoring responsibilities, supporting the development of junior and mid-level clinical professionals. It is well-suited for an experienced CRA ready to step into a broader leadership and strategic oversight capacity.
- Oversee clinical trial progress including timelines, enrollment, data cleaning, and compliance, ensuring corrective and preventive actions are implemented when needed.
- Review monitoring visit reports and ensure consistency, accuracy, and adherence to reporting standards across assigned teams.
- Act as a central communication link between monitors, site management associates, project leads, and study managers.
- Lead country-level project team meetings and provide structured status updates to regional and project leadership.
- Support and deliver project-specific training materials and onboarding guidance for clinical teams.
- Supervise source data verification processes, manage site-level data queries, and monitor study risks and deviations.
- Ensure proper handling, reconciliation, and accountability of investigational products and clinical supplies.
- Oversee Investigator Site File (ISF) and Trial Master File (TMF) reconciliation and ensure documentation compliance.
- Support audit preparation activities, coordinate resolution of findings, and oversee CAPA development and implementation.
- Contribute to site feasibility, startup activities, regulatory submissions, and vendor coordination where applicable.
- Monitor data integrity, protocol adherence, and overall study quality across assigned regions.
- Mentor and train clinical monitors, including onboarding and authorization visits for newly promoted staff.
- Degree in Life Sciences or related field (MD, PharmD, RN, MSc, or equivalent combination of education and experience).
- Minimum of 4+ years of clinical site monitoring experience, including participation in global Phase II and/or Phase III trials.
- Prior experience in a Lead CRA, Senior CRA, or equivalent oversight role is required.
- Strong background in oncology clinical trials is highly preferred.
- Additional therapeutic experience in areas such as cell therapy, gene therapy, radiopharmaceuticals, or gastroenterology is an advantage.
- Solid understanding of GCP, clinical trial regulations, and monitoring methodologies.
- Strong leadership, mentoring, communication, and cross-functional collaboration skills.
- Ability to manage multiple priorities in a dynamic, fast-paced clinical research environment.
- Proficiency in MS Office tools and clinical tracking systems.
- Willingness to travel as required, with a valid driver’s license if applicable.
- Full professional proficiency in English is required.
- Competitive salary package aligned with experience and market standards
- Opportunity to work in a global clinical research environment with diverse therapeutic areas
- Low-travel or hybrid oversight model focusing on remote leadership responsibilities
- Strong emphasis on professional development, training, and internal growth opportunities
- Exposure to advanced clinical trial programs including innovative therapies
- Collaborative and knowledge-sharing work culture
- Comprehensive benefits package including healthcare coverage and paid time off.