Lead Clinical Research Associate – Contract

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

📋 Description

• Act as the primary point of contact for study oversight, facilitating communication among CRAs, internal staff, study site personnel including investigators and coordinators, client representatives, and external vendors throughout all phases of the study.

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

• Develop, assess, and manage clinical plans and guidelines, encompassing the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals as per project specifications, review data reports, CTMS, distribute listings/reports to study CRAs, and collaborate with CRAs and site personnel to address data discrepancies.

• Design annotated visit report templates and other documentation and strategies pertaining to site management and monitoring.

• Assist in the training and development of team members, ensure adherence to study-specific training requirements, and confirm that training is properly documented.

• Provide guidance and support for CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; evaluate site visit reports and monitoring letters in alignment with study and SOP requirements.

• Oversee the Trial Master File (TMF)/eTMF and aid in filing and quality control processes.

• Monitor serious adverse events, protocol deviations, enrollment figures, informed consent forms (ICFs), study contacts, investigational supplies, and investigational products for assigned studies, reviewing with relevant study team members.

• Conduct qualification, initiation, interim, and closeout visits, providing visit reports according to monitoring guidelines as necessary.

⛳️ 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 CRA experience is preferred.

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

• A solutions-oriented mindset for problem-solving.

• Familiarity with the medical and pharmaceutical industries, 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 required.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

🏝️ Benefits

• ProTrials is dedicated to fostering a workplace that is free from discrimination and harassment.

• All qualified candidates will receive equal consideration for employment regardless of 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.