Clinical Research Associate/Senior Clinical Research Associate - Oncology Focus

Join Parexel FSP as a Clinical Research Associate (CRA) or Senior Clinical Research Associate (Sr CRA). We are seeking a talented individual with a strong background in oncology and a preference for cell therapy experience.

Job Purpose:

The CRA plays a crucial role in the success of clinical trials by managing sites effectively and ensuring studies are delivered on time. You will collaborate closely 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.