Clinical Research Associate; CRA; Oncology; Remote

Candidate must reside in:
Alabama, Georgia, Colorado, Massachusetts, Michigan, Maryland, Pennsylvania.

• Ensure protocol and site performance/compliance under CRA-Manager oversight (ICH-GCP, country regulations, internal policies, quality standards, adverse event reporting).
• Act as primary site contact/site manager across all study phases.
• Develop/expand clinical research territory by finding and developing new sites.
• Serve as SME for monitoring processes/systems in internal meetings.
• Manage site relationships; perform site management/monitoring per ICH-GCP, Sponsor SOPs, local laws, protocol, Site Monitoring Plan.
• Conduct remote/on-site monitoring to ensure data integrity and subject rights/safety/well-being.
• Conduct validation/initiation/monitoring/close-out visits; complete accurate visit and contact reports timely.
• Collect/review/monitor regulatory documentation for start-up/maintenance/close-out.
• Communicate with investigators/site staff on protocol conduct, recruitment/retention, deviations, documentation, audits/inspections.
• Identify/resolve quality/compliance issues and elevate as needed; partner with internal/external stakeholders (IRB/IECs, regulators, vendors).
• Maintain documentation in CTMS/eTMF; support/lead audits/inspections and co-monitoring.

• Fluent in local languages and English (verbal/written); excellent communication.
• Strong clinical research and GCP/ICH and country clinical research law knowledge; good documentation practices.
• Proven site management/monitoring skills and independent judgment; strong IT skills.
• Associate’s degree/certificate (or equivalent) + 5+ years relevant healthcare experience with 2+ years direct site management (monitoring) in bio/pharma/CRO; OR Bachelor’s degree (or above) + 2+ years.

65%–75% (about 2–3 days/week); current driver’s license required.

• annual bonus and long-term incentive; medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.