[Hiring] Lead Clinical Research Associate @ProTrials Research

Role Description

ProTrials is seeking a Contract Lead Clinical Research Associate to join our team. The Contract Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The Contract LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The Contract LCRA ensures adequate study monitoring resources are in place for the study. The Contract LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them.

• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study.
• Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements.
• Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies.
• Create annotated visit report templates and other documents and strategies related to site management and monitoring.
• Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented.
• Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements.
• Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control.
• Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team.
• Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed.

Qualifications

• RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training.
• Previous CRA experience preferred.
• Proven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy.
• Solutions-oriented approach to problem solving.
• Familiarity with medical and pharmaceutical industry, and related terminology and practices.
• Extensive knowledge of Food and Drug Administration regulations and their practical implementation.
• Willingness to travel and perform remote and on-site monitoring, if needed.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Company Description

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.

Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.