Job Summary:

Join our team as a Senior Clinical Research Associate (SrCRA) where you will play a critical role in the successful execution of oncology studies at various sites. As a vital member of our local study teams, you will collaborate closely with other CRAs and leadership to ensure that study commitments are met efficiently and effectively. Your expertise will guide site interactions, ensuring compliance with international guidelines, local regulations, and client procedural documents throughout the study lifecycle.

Key Accountabilities:
• Assist in identifying and selecting qualified investigators.
• Manage study start-up processes including Site Qualification Visits and document submissions to Ethics Committees and Regulatory Authorities.
• Provide training and support to investigators and site staff on study protocols and Risk-Based Quality Management principles.
• Ensure all site staff are compliant with training requirements, including ICH-GCP, maintaining an inspection-ready status.
• Actively engage in Local Study Team meetings and contribute to National Investigators meetings.
• Initiate, monitor, and close study sites in line with study plans and Client Procedural Documents.
• Drive site performance by identifying challenges and implementing timely solutions.
• Update Clinical Trial Management Systems (CTMS) and ensure accurate reporting of study data.
• Manage study supplies and ensure proper documentation of drug accountability.
• Conduct both remote and onsite monitoring visits, adhering to the Monitoring Plan timelines.
• Perform comprehensive Source Data Review and Source Data Verification to ensure data integrity.
• Regularly assess site quality and adapt monitoring strategies as necessary.
• Facilitate the resolution of data queries quickly and efficiently.
• Coordinate with data management for maintaining high-quality study data.
• Ensure timely reporting of Serious Adverse Events and facilitate necessary follow-ups.
• Draft and finalize monitoring visit reports and communicate findings with Investigators.
• Follow up on outstanding site actions to achieve timely resolution.
• Escalate any significant quality compliance issues to management as required.
• Assist sites in maintaining an inspection-ready Investigator Site File.
• Prepare for regulatory inspections and audits in collaboration with local leadership.
• Ensure timely documentation is uploaded to the electronic Trial Master File (eTMF) in compliance with regulations.
• Collaborate with local Medical Scientific Liaisons as directed.

Required Skills:
• Exceptional attention to detail.
• Strong written and verbal communication abilities.
• Excellent teamwork and interpersonal skills.
• Outstanding negotiation capabilities.
• Proficiency in English; fluency in relevant local languages is a must.
• Ability to thrive in a remote working environment and adapt to change positively.
• Proactive in seeking efficient methods for conducting quality clinical trials.
• Analytical thinking and problem-solving aptitude.
• Ability to manage competing tasks and prioritize effectively.
• Tech-savvy with a good understanding of the impact of technology on project execution.

Experience and Knowledge:
• 5+ years of CRA experience in a CRO or pharmaceutical environment.
• 2+ years of specific experience in oncology clinical monitoring.
• Familiarity with risk-based monitoring practices, including remote monitoring.
• Strong cultural awareness and adaptability.

Education:
• Bachelor's degree required.

Other Requirements:
• Willingness to travel as necessary.
• A valid driving license in accordance with local regulations.

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Parexel is proud to be an equal opportunity employer. We welcome all qualified applicants without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.