Lead Clinical Research Associate

The company 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 the company, 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

The 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 LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The LCRA ensures adequate study monitoring resources are in place for the study. The 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

HERE IS WHAT WE OFFER

• 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 the company, 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.

Except as otherwise permitted or required by applicable law or regulatory requirements, the company will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.

Information collected during application completion may be retained for a reasonable period of time and in accordance with the company’s established retention policies. Applicants seeking more information may contact [link for members]

The company is an equal opportunity employer. The company is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.