Clinical Research Associate – Oncology

This is a fully remote position, open to applicants in District of Columbia, +7 more states.

📋 Description

• Serve as the main point of contact and site manager throughout all stages of a clinical research study, assuming overall responsibility for designated sites.

• Cultivate strong relationships with sites and ensure continuity of these relationships throughout all phases of the trial.

• Conduct clinical study site management and monitoring activities in accordance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, local laws and regulations, the protocol, the Site Monitoring Plan, and associated documents.

• Acquire a comprehensive understanding of the study protocol and related procedures.

• Coordinate and oversee various tasks in collaboration with other sponsor roles to ensure Site Ready status.

• Engage and provide insights during site selection and validation activities.

• Execute remote and on-site monitoring and oversight activities utilizing various tools to ensure: Data generated at the site is complete, accurate, and unbiased; and the rights, safety, and well-being of subjects are safeguarded.

• Conduct site visits, including but not limited to validation, initiation, monitoring, and closeout visits, and document clear, comprehensive, and accurate visit and non-visit contact reports in a timely manner.

• Collect, review, and monitor necessary regulatory documentation for study start-up, maintenance, and close-out.

• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.

• Identify, assess, and resolve site performance, quality, or compliance issues and escalate as necessary according to the defined CRA Escalation Pathway in collaboration with the Clinical Research Manager and Partner Line Manager.

• Manage and maintain information and documentation in the Clinical Trial Management System, electronic Trial Master File, and various other systems as applicable and within timelines.

• Enhance CRA team knowledge by acting as a process Subject Matter Expert, mentor, and sharing best practices as appropriate or required.

• Support and/or lead audit and inspection activities as necessary.

• Conduct co-monitoring visits where appropriate.

⛳️ Requirements

• A minimum of 2 years of direct on-site monitoring experience in a biotech, pharmaceutical, or CRO organization.

• Experience in oncology monitoring is required.

• Strong understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH guidelines, and country-specific clinical research laws and guidelines.

• Practical knowledge of Good Documentation Practices.

• Proven skills in Site Management, including managing site performance and patient recruitment.

• Demonstrated high level of monitoring skill with independent professional judgment.

• Proficient IT skills (including MS Office, various clinical IT applications on computers, tablets, and mobile devices) with the ability to adapt to new IT applications across different devices.

• Ability to understand and analyze data/metrics and take appropriate action.

• Demonstrated high level of monitoring skill with independent professional judgment.

• Capable of working independently across multiple protocols, sites, and therapy areas.

• Shows a strong commitment to customer focus.

🏝️ Benefits

• Health insurance.

• Professional development opportunities.