Lead Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as the primary point of contact for study oversight, liaising between CRAs, internal staff, study site personnel, investigators, coordinators, client representatives, and external vendors.

• Ensure that clinical monitoring activities adhere to SOPs, applicable regulations, good clinical practices, key performance indicators, and specific study requirements.

• Develop, review, and oversee clinical plans, monitoring guidelines, study timelines, data reports, CTMS, and resolution of discrepancies.

• Create annotated visit report templates along with site management and monitoring documents and strategies.

• Assist in the training and development of team members, ensuring compliance with training requirements and maintaining documentation.

• Guide and support CRAs, CTAs, and external CROs in monitoring, co-monitoring, training, and conducting audit visits.

• Review site visit reports and monitoring correspondence.

• Oversee the TMF/eTMF, assisting with filing and ensuring quality control.

• Track serious adverse events, protocol deviations, enrollment statistics, ICFs, study contacts, investigational supplies, and investigational products.

• Conduct qualification, initiation, interim, and close-out visits, providing visit reports as necessary.

• Offer direction and leadership to CRA and CTA teams.

• Ensure the study initiation, enrollment, conduct, and completion are carried out accurately and on time.

• Identify clinical monitoring quality issues and collaborate with the study team to develop corrective action plans.

⛳️ Requirements

• RN, Bachelor’s degree, or advanced degree in biological sciences or a related field, or a comparable combination of relevant experience, education, and training.

• Prior CRA experience is preferred.

• Demonstrated excellence in communication, organization, prioritization, presentation, discretion, and attention to detail.

• A solutions-oriented mindset for effective problem solving.

• Familiarity with the medical and pharmaceutical sectors, including terminology and practices.

• In-depth understanding of Food and Drug Administration regulations and their practical application.

• Willingness to travel and engage in both remote and on-site monitoring as necessary.

• Proficient in Microsoft Word, Excel, and PowerPoint.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance options available for you and your family.

• Flexible paid time off (PTO).

• 401(k) plan with company matching contributions.

• Support and opportunities for professional growth and career development.

• A collaborative community with supportive coworkers.