Clinical Research Associate/Senior Clinical Research Associate - Oncology Focus

sely with a dynamic team to monitor study conduct, ensuring compliance with industry standards and local regulations.

Key Responsibilities:

Site Management:
• Assist in selecting and training potential investigators and site staff.
• Conduct Site Qualification Visits and manage necessary documentation for regulatory compliance.
• Ensure study teams are well-prepared and sites are ready for audits and inspections.
• Participate proactively in Local Study Team meetings, providing updates on site performance and patient recruitment.
• Initiate, monitor, and close study sites according to Client Procedural Documents.
• Identify study-related issues and ensure timely resolutions while updating critical study data in CTMS.
• Conduct remote and onsite monitoring visits, ensuring compliance with the Monitoring Plan.
• Oversee data quality and query resolution, ensuring adherence to ICH-GCP and client standards.
• Support auditing and inspection activities in collaboration with Local Study Associates.

Compliance:
• Adhere to ethical standards and company policies while ensuring compliance with local regulations.
• Maintain accurate timesheets and manage expense reports efficiently.
• Stay updated with job-related training, policies, and industry standards.

Desired Skills:
• Exceptional attention to detail and excellent written and verbal communication skills.
• Strong collaboration and negotiation capabilities, adaptable in a remote work environment.
• Proficient in leveraging technology to facilitate efficient clinical trials.

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

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

EEO Disclaimer:

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