Clinical Research Associate; CRA - Oncology; Remote

Job Description

The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA‑Manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and work streams as SME for monitoring processes and systems.

Candidate must reside in one of the following locations:
New York, New Jersey, Texas, Chicago, Southern California, Missouri.

San Francisco Residents Only:
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only:
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

• Develop strong site relationships and ensure continuity through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH‑GCP, sponsor SOPs, local laws and regulations, protocol, site monitoring plan and associated documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Coordinate and manage various tasks with other sponsor roles to achieve site readiness.
• Participate and provide inputs on site selection and validation activities.
• Perform remote and on‑site monitoring and oversight using various tools to ensure data at site are complete, accurate and unbiased and that subjects’ rights, safety and well‑being are protected.
• Conduct site visits (validation, initiation, monitoring, close‑out) and record clear, comprehensive and accurate visit & non‑visit contact reports in a timely manner.
• Collect, review and monitor required regulatory documentation for study start‑up, maintenance and close‑out.
• Communicate with investigators and site staff on protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify, assess and resolve site performance, quality or compliance problems and elevate per the CRA escalation pathway in collaboration with CRA‑Manager, CRM, TA Head and CRD as needed.
• Work collaboratively with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ functional areas and external vendors, IRB/IECs and regulatory authorities.
• Manage and maintain information and documentation in CTMS, eTMF and other systems per timelines.
• Contribute to CRA team knowledge as a process SME, mentor and share best practices.
• Support and/or lead audit/inspection activities as needed.
• Perform co‑monitoring visits when appropriate.
• Contribute to identification of new potential sites following the country strategy defined by CRD and/or CRA‑Manager.

• Ability to travel domestically and internationally approximately 65%–75% of working time.
• Expected to travel 2–3 days per week.
• Current driver’s license required.

• Fluent in local languages and English (verbal and written) with excellent communication skills.
• Understanding of clinical research phases, current GCP/ICH and country guidelines.
• Knowledge of global, country/regional clinical research guidelines and ability to work within them.
• Hands‑on knowledge of good documentation practices.
• Proven skills in site management, site performance and patient recruitment.
• High level of monitoring skill with independent professional judgment.
• IT proficiency (MS Office, clinical IT applications across devices).
• Ability to analyze data/metrics and act accordingly.
• Complex issue management with a solution‑oriented approach.
• Root cause analysis and implementation of preventive and corrective actions.