AI Summary

ProTrials seeks a Contract Lead Clinical Research Associate to lead a CRA/CTA team, providing study oversight, ensuring compliant monitoring activities, managing timelines and deliverables, resolving data issues, and supporting TMF/eTMF and serious adverse event tracking.

About this role

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.

We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.

ABOUT THE JOB

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.

HERE IS WHAT YOU WILL DO:

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

HERE IS WHAT YOU BRING TO THE TABLE:

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

Skills

Clinical MonitoringClinical Trial ManagementClinical TrialsExcelGood Clinical Practice (GCP)Microsoft WordPowerPointSOPsTMF/eTMF

Lead Clinical Research Associate - Contract Position

About this role

HERE IS WHAT YOU WILL DO:

HERE IS WHAT YOU BRING TO THE TABLE:

Skills

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