Lead Clinical Research Associate

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

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

Your wellness matters to us – that’s why we provide full medical, dental, and vision insurance options for you and your family.

We know life doesn’t pause for work – we provide flexible PTO so you can take care of what matters, both personally and professionally.

You invest in your future – and so do we. Our 401(k) plan includes a company match to help you reach your financial goals.

At ProTrials, we are committed to your growth. Whether you’re looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward.

We have the best coworkers, if we do say so ourselves.