Clinical Research Associate (CRA) - Oncology (Remote)

Stellenbeschreibung:

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.