The Role
Lead CRA provides direction to CRA/CTA teams, ensures monitoring per SOPs/GCP/FDA, manages monitoring plans, TMF/eTMF and CTMS, trains staff, conducts site visits, tracks safety/deviations/enrollment, and supports project management.
Summary Generated by Built In
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
Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials 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 [email protected].
ProTrials is an equal opportunity employer. ProTrials 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.
Skills Required
- RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of experience
- Previous Clinical Research Associate (CRA) experience
- Proven communication, organization, prioritization, presentation, discretion, and accuracy
- Solutions-oriented approach to problem solving
- Familiarity with medical and pharmaceutical industry terminology and practices
- Extensive knowledge of FDA regulations and their practical implementation
- Willingness to travel and perform remote and on-site monitoring as needed
- Proficiency in Microsoft Word, Excel, and PowerPoint
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The Company
What We Do
ProTrials Research, Inc. is a mid-sized, full-service clinical research organization (CRO) founded in 1996. It partners with pharmaceutical, biotechnology, and medical device sponsors to provide clinical operations services, including study management, site monitoring, biometrics, and regulatory support. The company is a woman-owned business headquartered in Los Gatos, California, with a global reach, committed to delivering high-quality research to advance clinical trial success and improve patient health.
