Lead Clinical Research Associate

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

📋 Description

• Serve as the primary point of contact, overseeing studies and facilitating communication among CRAs, internal staff, study site personnel such as investigators and coordinators, client representatives, and external vendors throughout all phases of the study.

• Ensure that the clinical monitoring activities conducted by the CRA teams adhere to relevant Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and specific study requirements.

• Develop, review, and manage clinical plans and guidelines, which include the clinical monitoring plan and study timelines; guarantee adherence to monitoring intervals based on project needs, review data reports and CTMS, distribute listings/reports to study CRAs, and collaborate with CRAs and site staff to address data discrepancies.

• Generate annotated visit report templates and other documents and strategies pertinent to site management and monitoring.

• Facilitate the training and development of team members, ensuring compliance with study-specific training mandates and proper documentation of training activities.

• Guide and assist CRAs, CTAs, and external contract research organizations in areas such as monitoring, co-monitoring, training, and audit visits; evaluate site visit reports and monitoring correspondence in line with study and SOP standards.

• Oversee the Trial Master File (TMF)/eTMF and support filing and quality control efforts.

• Monitor serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational products for the assigned study, reviewing this information with appropriate study team members.

• Conduct qualification, initiation, interim, and close-out visits, providing visit reports as dictated by monitoring guidelines as required.

⛳️ Requirements

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

• Prior experience as a CRA is preferred.

• Demonstrated excellence in professional skills such as communication, organization, prioritization, presentation, discretion, and accuracy.

• A solution-oriented mindset when addressing challenges.

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

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

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

• Proficient in Microsoft Word, Excel, and PowerPoint.

🏝️ Benefits

• Achieve work-life balance that accommodates meaningful workloads alongside daily life.

• Join a collaborative community dedicated to fostering a healthier world.