Senior Clinical Research Associate – Oncology Experience Required

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Execute site management tasks to guarantee adherence to the protocol, monitoring plan, ICH GCP, local regulatory standards, and sponsor SOPs.

• Carry out site qualification, initiation, interim, and close-out visits, both in-person and virtually.

• Collaborate with the Clinical Trial Liaison (CTL) and other sponsor departments (e.g., Study Start-Up, Global Partnerships, and Trial Optimization) to facilitate site activation and deliverables.

• Develop and sustain effective professional relationships with investigator site personnel, ensuring efficient communication and problem-solving during the study.

• Conduct drug accountability, reconciliation, and destruction, ensuring adherence to protocol for storage and shipping requirements.

• Prepare and uphold the Oversight Monitoring Plan.

• Review study metrics, evaluate Clinical Research Associate (CRA) and Investigator Site performance, and identify sites for oversight monitoring visits.

• Perform Oversight Monitoring Visits at sites, either independently or in collaboration with other CRAs.

• Evaluate site source documentation and confirm accurate data capture (following ALCOA principles).

• Assess and report on the status of study execution at the investigator site, ensuring appropriate follow-up on any identified issues or action items.

• Ensure that site regulatory files are up-to-date and verify the timely submission of study documentation, including safety reporting.

• Craft and submit precise monitoring visit reports, oversight monitoring visit reports, and study correspondence promptly.

• Periodically confirm the completeness of site documentation (e.g., contents of the investigator site file/regulatory binder).

• Identify and document protocol deviations, escalate non-compliance issues, and resolve study-related challenges as needed.

• Monitor, analyze, and report issues, escalating them to the appropriate teams when necessary.

• Maintain continuous communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.

• Actively engage in team meetings and process enhancement initiatives to improve study results.

• Assist with inspection readiness activities and ensure sites uphold data integrity and protocol commitments.

⛳️ Requirements

• At least 4 years of on-site trial monitoring experience.

• A Bachelor’s degree, nursing degree, or equivalent is required, with a preference for science-related fields.

• Proficient understanding of the clinical drug development process, ICH GCP guidelines, and relevant regulatory requirements (e.g., FDA, EMA, PMDA).

• Strong communication and interpersonal skills to cultivate relationships both internally and externally.

• Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories.

• Proven ability to produce clear and concise written reports.

• Effective prioritization and time management abilities.

• Proficiency in Flemish/Dutch is highly preferred.

🏝️ Benefits

• Opportunities for professional development.

• A welcoming and friendly work atmosphere.