Clinical Research Associate / Senior Clinical Research Associate - Oncology Specialist

u will work collaboratively with a vibrant team to oversee study conduct, ensuring compliance with industry standards and local regulations.

Key Responsibilities:

Site Management:
• Assist in the selection and training of potential investigators and site staff.
• Conduct Site Qualification Visits and manage regulatory compliance documentation.
• Prepare study teams for audits and inspections to ensure readiness.
• Engage actively in Local Study Team meetings, providing insights on site performance and patient recruitment.
• Initiate, monitor, and close study sites in accordance with Client Procedural Documents.
• Identify study-related issues, ensuring timely resolutions and updating critical study data in CTMS.
• Execute remote and onsite monitoring visits to comply with the Monitoring Plan.
• Oversee data quality and resolve queries, maintaining adherence to ICH-GCP and client standards.
• Support auditing and inspection activities in collaboration with Local Study Associates.

Compliance:
• Uphold ethical standards and company policies while ensuring compliance with local regulations.
• Maintain accurate timesheets and manage expense reports effectively.
• Stay informed on job-related training, policies, and industry standards.

Desired Skills:
• Meticulous attention to detail with exemplary written and verbal communication skills.
• Strong collaborative and negotiation skills, adaptable in a remote work setting.
• Proficient in using technology to enhance the efficiency of clinical trials.

Qualifications:
• Bachelor's degree in a relevant field, ideally in life sciences or related disciplines.
• Prior experience in clinical research and a solid understanding of the drug development process.

Additional Requirements:
• Willingness to travel nationally and internationally as needed.
• Valid driving license, if applicable.

EEO Disclaimer:

Parexel is an equal opportunity employer. We encourage applications from all qualified individuals, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.