Principal Clinical Research Associate

Principal Clinical Research Associate Empresa: Barrington James Tipo de Emprego: Periodo Integral Localização: Manaus, Amazonas Número de Aplicantes: 000+ Descrição do Emprego - Principal Clinical Research Associate My Client is a leading global pharma company who are searching for a 0.5FTE Freelance Consultant Principal CRA candidate to come on board for a long term project. Site locations will include Brazil, Argentina and Mexico, with 40% travel expected. Position Summary The Principal Clinical Research Associate (CRA) plays a key role in overseeing clinical trial monitoring. Working closely with the Clinical Project Manager and Clinical Trial Associate, you'll help guide the clinical trial teams, ensuring studies are conducted smoothly and successfully. You'll monitor trends, develop strategies to meet goals, and ensure site compliance and data quality. Key Responsibilities Clinical Monitoring Oversight and Collaboration Help identify and select Investigators and study sites. Participate in study management meetings and coordinate monitoring activities. Identify and resolve monitoring issues, reporting trends to the study team. Contribute to key study documents like monitoring plans, CRFs, and consent forms. Check the Trial Master File (TMF) for completeness and assist with audits and inspections. Oversight of CRO Clinical Monitoring Plan and conduct monitoring oversight visits to ensure study compliance. Ensure CRO CRAs are well-trained and provide additional support as needed. Monitor CRO performance, assist study sites, and build relationships with site staff. Review monitoring reports, track compliance, and escalate issues as necessary. Ensure site files are complete and ready for inspection. Participate in calls with CRO CRAs to stay updated on site performance. Qualifications Bachelor's degree in life sciences or a related field; additional training in clinical trials is a plus. At least 5 years of clinical monitoring experience, with 4 years in field monitoring. Experience with site selection, initiation, and close-out visits across multiple countries. Biotech experience is beneficial. Experience overseeing CROs and mentoring CRAs. Skills and Abilities Strong knowledge of clinical trial regulations (ICH GCP, FDA/EMA). Excellent communication and organizational skills. Ability to multitask in a dynamic environment. Fluent in English; additional European languages are a plus. Willingness to travel up to 40%.
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