OBJECTIVE

As a Clinical Research Associate (CRA) specializing in oncology, you will play a crucial role in the execution and management of Phase 1, Phase 2, and Phase 3 clinical trials. You will collaborate closely with cross-functional teams to ensure adherence to protocols, regulatory requirements, and high-quality standards throughout the clinical trial process.

EDUCATION/EXPERIENCE

• Bachelor’s degree in life sciences or a related field; advanced degree (e.g., Master’s, PhD) preferred.
• Minimum of 2 years of CRA experience, preferably in oncology.

KNOWLEDGE / SKILL / ABILITY

• Proficiency in understanding clinical trial protocols, GCP, regulatory requirements, EDC, EMR, eTMF, and CTMS.
• Strong organizational skills with attention to detail and the ability to prioritize tasks effectively.
• Excellent communication and interpersonal skills, both written and verbal.
• Ability to travel domestically and internationally as required. Typical CRA travel is up to 50%, however, at times can go up to 75% for certain project deliverables (e.g. database lock, etc.).

Essential Functions

• Study Initiation and Planning:
• Participate in study feasibility assessments, and site selection processes.
• Assist in the preparation and review of essential documents such as informed consent forms (ICFs) and study manuals.
• Clinical Trial Monitoring:
• Conduct site qualification, site initiation, interim monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory guidelines.
• Regularly review Investigator Site Files (ISF) to assist in maintaining site audit readiness
• Perform routine site communication, including resolving site issues and providing protocol training as necessary.
• Document protocol deviations in CTMS with clear description of deviation, root cause, and actions taken to prevent recurrence.
• Data Collection and Management:
• Monitor and review clinical data to ensure accuracy, completeness, and timeliness.
• Work closely with data management teams to resolve data discrepancies and ensure data integrity throughout the trial.
• Regulatory Compliance:
• Assist in the preparation of regulatory submissions and support inspections/audits as needed.
• Ensure that all clinical trial activities are conducted in accordance with applicable regulatory requirements and internal procedures.
• Collaboration and Communication:
• Foster strong relationships with investigators, study coordinators, and other key stakeholders.
• Provide regular updates to internal teams and management regarding study progress, issues, and resolutions.
• Email sites weekly site management communications that provide them with their open queries, missing data entry, missing image uploads, and any other important information the site needs to meet the trial data expectations.
• Attend Bi-weekly CRA meetings led by Clinical Lead

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• May be required to sit or stand for long periods of 8+ hours a day while performing duties