Clinical Research Associate
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Job Description
Clinical Research Associate monitoring oncology and hematology clinical trials for BeOne Medicines. Managing sites, compliance, recruitment, data quality, and study milestones across Spain.
Responsibilities:
- Execute clinical monitoring activities at clinical trial sites in accordance with ICH guidelines, GCP, local regulations, and applicable SOPs
- Perform monitoring activities for selection, initiation, conduct, recruitment, quality data collection, and timely completion of oncology/hematology clinical trials
- Collaborate with the Regional Clinical Operations Manager to adhere to study timelines and maintain quality standards
- Identify gaps and areas for improvement and propose CAPA
- Support study start-up and provide local expertise
- Perform feasibility, site identification, selection, and evaluation
- Provide protocol and related study training to assigned sites
- Conduct pre-study, initiation, routine monitoring, and closeout visits
- Conduct co-monitoring visits when required
- Complete monitoring visit reports according to ICH-GCP, BeOne Medicines standards, and SOPs
- Manage site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
- Maintain communication with sites and report progress, issues, and proposed actions to Clinical Operations
- Ensure inspection readiness of the study and sites
- Collaborate with study sites to deliver study milestones, including startup, recruitment, database analyses, and closeout
- Attend disease-indication-specific and general CRA training as required
- Facilitate Study Oversight Visits, site audits, and/or inspections as required
- Evaluate site practices and escalate quality and/or GCP issues
- Anticipate and identify site issues, propose corrective and preventative actions, identify gaps, and promote operational excellence and innovation
Requirements:
- BS in a relevant scientific discipline and minimum of 2 years of monitoring experience
- Experience in oncology global trials preferred
- Thorough knowledge of ICH and associated regulatory guidelines
- At least 2 years of CRA monitoring experience in the pharmaceutical or CRO industry
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English & Spanish (writing and speaking)
- Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
- Willingness to travel up to 60%
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