Job Details

Job Title: Clinical Research Associate (CRA) - Oncology

Location: Multiple in CA

Position Type: Full-Time

Job Summary: We are seeking a dedicated and experienced Clinical Research Associate (CRA) with a focus on Oncology to join our dynamic team. The CRA will be responsible for monitoring and managing clinical trials to ensure that they are conducted in accordance with established protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.

Key Responsibilities:

• Conduct site visits to assess protocol and regulatory compliance, and to ensure the integrity of clinical data.
• Monitor patient safety and report adverse events.
• Review and verify case report forms (CRFs) for completeness and accuracy.
• Liaise with investigators and site staff to resolve data discrepancies and ensure timely data entry.
• Ensure proper storage and dispensation of investigational products.
• Maintain study documentation and ensure that all files are up to date.
• Participate in the development of study protocols, informed consent forms, and case report forms.
• Assist in the preparation of regulatory submissions and progress reports.
• Provide training and support to site staff on study protocols and GCP guidelines.
• Collaborate with cross-functional teams to ensure the successful completion of clinical trials.

Qualifications:

• Bachelor's degree in a life science or healthcare-related field.
• Minimum of 2 years of experience as a CRA, with a focus on Oncology trials.
• In-depth knowledge of GCP and ICH guidelines.
• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Ability to travel up to 50% of the time.
• Proficiency in MS Office Suite.

Preferred Qualifications:

• Advanced degree (e.g., Master's, PhD) in a related field.
• Experience with electronic data capture (EDC) systems.
• Familiarity with regulatory requirements in the Oncology therapeutic area.