Lead Clinical Research Associate

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.

• 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 (SOPs), 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 the 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's, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training
• Previous CRA experience preferred
• 5 years of experience
• Proven excellence in professional skills, including communication, organization, prioritization, presentation, discretion, and accuracy
• Solutions-oriented approach to problem solving
• Familiarity with the 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 Power Point

Clinical Research, Clinical Trial Management, Study Oversight, Clinical Monitoring, CRA Leadership, Team Training and Development, Site Management, Vendor Management, CRO Oversight, Clinical Monitoring Plans, Study Timelines, CTMS, TMF/eTMF, GCP, FDA Regulations, SOP Compliance, Quality Control, Data Review, Data Discrepancy Resolution, Site Visit Reports, Monitoring Letters, Serious Adverse Event Tracking, Protocol Deviations, Informed Consent Forms, Investigational Product Accountability, Clinical Supplies, Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Close-Out Visits, Audit Support, Project Management, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Communication, Organization, Prioritization, Presentation Skills, Problem Solving