Senior Clinical Research Associate

Remote Senior Clinical Research Associate Position - Oncology Preferred Job Purpose: The Senior Clinical Research Associate (CRA) plays a vital role in ensuring the successful delivery of clinical studies at assigned sites. Collaborating closely with other CRAs and the Local Study Team, the CRA ensures that study commitments are met effectively and on time. This role serves as the primary contact between the study and the site, monitoring the study to guarantee adherence to protocols. Key Accountabilities: Site Management Responsibilities Assist in selecting potential investigators for studies. Responsible for study start-up and regulatory maintenance, including Site Qualification Visits and submission of necessary documentation to authorities. Provide training and support to site staff on study-related matters. Ensure site staff are properly trained in ICH-GCP and maintain readiness for inspections. Participate actively in Local Study Team meetings and contribute to National Investigator meetings when relevant. Monitor and close study sites in compliance with established protocols, sharing insights on recruitment and site performance. Drive site performance, proactively addressing and escalating study-related issues as needed. Update necessary systems with site data as per timelines. Manage study supplies and ensure drug accountability and proper handling at study sites. Conduct monitoring visits—both remote and onsite—in line with the study’s Monitoring Plan. Perform reviews and verifications to ensure data accuracy and quality. Conduct regular risk assessments and adjust monitoring intensity as necessary. Facilitate timely resolution of data queries. Collaborate with data management to ensure study data quality. Accurately report Serious Adverse Events and their follow-ups. Prepare monitoring visit reports and provide timely feedback to investigators. Maintain compliance with all required quality processes and ensure documentation is thorough and ready for audits. Assist sites in maintaining an inspection-ready Investigator Site File. Collaborate with local Medical Science Liaisons as needed. Compliance with Sponsor Standards Adhere to the Client's Code of Ethics and all operational policies. Ensure compliance with local, national, and regional regulations. Accurately complete timesheets as required. Skills (Essential): Exceptional attention to detail. Strong written and verbal communication skills. Effective collaboration and interpersonal abilities. Good negotiation skills. Proficient in English and fluent in local languages as required. Skills (Desirable): Experience with remote collaboration. A positive approach to change and innovation. Strong analytical and problem-solving capabilities. Ability to manage multiple tasks with conflicting deadlines. Technological proficiency and adaptability in e-enabled environments. Knowledge and Experience (Essential): Thorough understanding of ICH-GCP guidelines and local regulations. Basic knowledge of GMP/GDP. Medical knowledge relevant to clinical trials. Understanding of the drug development process and clinical study management. Knowledge and Experience (Desired): Familiarity with risk-based monitoring, including remote techniques. Good cultural awareness to navigate diverse environments. Education: Bachelor's degree in a relevant discipline, preferably life sciences or equivalent. Other: Ability to travel nationally/internationally as required. Valid driving license as per country regulations. Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.

Created: 2026-03-10