Lead Clinical Research Associate – Contract

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

📋 Description

• Serve as the main point of contact for study oversight, liaising with CRAs, internal teams, site staff including investigators and coordinators, client personnel, and external vendors throughout all phases of the study.

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

• Create, review, and oversee clinical plans and guidelines, which include clinical monitoring plans and study timelines.

• Guarantee compliance with monitoring intervals, assess data reports and CTMS, share reports with study CRAs, and address data discrepancies with CRAs and site personnel.

• Develop annotated visit report templates and documents, as well as strategies for site management and monitoring.

• Assist in the training and development of team members, ensuring compliance and documentation for study-specific training.

• Provide guidance and support to CRAs, CTAs, and external CROs concerning monitoring, co-monitoring, training, and audit visits.

• Evaluate site visit reports and monitoring letters in accordance with study and SOP guidelines.

• Oversee the Trial Master File (TMF)/eTMF, aiding in filing and ensuring quality control.

• Monitor serious adverse events, protocol deviations, enrollment figures, ICFs, study contacts, investigational supplies, and investigational product status.

• Conduct qualification, initiation, interim, and close-out visits, delivering visit reports as required.

• Provide leadership and direction to CRA and CTA teams, ensuring timely study initiation and completion, supporting project management, ensuring adequate monitoring resources, and identifying and resolving quality issues.

⛳️ Requirements

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

• Prior experience as a CRA is preferred.

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

• A solutions-driven approach to problem-solving.

• Familiarity with the medical and pharmaceutical industry, including related vocabulary and practices.

• Comprehensive understanding of Food and Drug Administration regulations and their pragmatic application.

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

• Proficient in Microsoft Word, Excel, and PowerPoint.

🏝️ Benefits

• Remote work arrangement available.

• Contract position.

• Equal opportunity workplace dedicated to preventing discrimination and harassment.