BeOne Medicines is looking for a Senior Clinical Research Associate to execute clinical monitoring activities at trial sites, ensuring adherence to ICH-GCP guidelines, local regulations, and SOPs. You will be instrumental in the timely conduct and completion of oncology/onco-hematology clinical trials within your assigned region.

What You'll Do

Execute clinical monitoring activities at clinical trial sites in accordance with ICH guidelines, GCP, local regulations, and SOPs.
Perform monitoring activities related to selection, initiation, conduct (recruitment, quality data collection), and timely completion of oncology/onco-hematology clinical trials.
Complete appropriate therapeutic, protocol, and clinical research training/CRA training.
Perform site selection and evaluation, supporting initial list of sites and recruitment targets.
Provide protocol and related study training to assigned sites.
Conduct onsite/remote pre-study, initiation, routine monitoring, and closeout visits per monitoring plan and applicable SOPs.
Conduct co-monitoring visits, if required.
Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans.
Manage sites and site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
Ensure copies/originals of site documents are available for filing in the TMF and verify the ISF is maintained per GCP/ICH and local regulations.
Ensure inspection readiness of the study and sites.
Establish regular lines of communication with sites and report site progress, issues, and proposed action to Clinical Operations.
Collaborate with Country and Regional Clinical Study Managers and sites to ensure timely delivery of study milestones.
Facilitate Study Compliance Visits (SCVs), site audits, and/or inspections.
Evaluate the quality and integrity of site practices and escalate quality/GCP issues as appropriate.
Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities.
Mentor junior staff (Associate CRA and CRA).
Act as the escalation point person for CRA(s) with site-related issues and concerns.
May review visit reports, follow up on issue resolution, and communicate significant risks to the Country/Regional Clinical Study Manager.
May serve as subject matter expert for clinical operations, country regulations, and monitoring-related activities.

What We're Looking For

BS in a scientific or healthcare discipline preferred.
At least 3-5 years of monitoring experience.
At least 3-5 years of (CRA) monitoring experience in the pharmaceutical or CRO industry.
Advanced knowledge of applicable clinical research regulatory requirements: Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and associated regulatory guidelines.
Excellent communication and interpersonal skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and other internal/external stakeholders.
Excellent organizational and problem-solving skills and ability to prioritize and multitask.
Effective time management skills.
Written and verbal communication skills, including a good command of the English language.
Efficient in Microsoft Word, Excel, PowerPoint, Outlook and use of a laptop computer and iPhone.
Travel: up to 60%.

Nice to Have

Experience in oncology/onco-hematology global trials.
Experience in oncology/onco-hematology trials.

Technical Stack

Microsoft Word, Excel, PowerPoint, Outlook

Team & Environment

Collaborates with Country and Regional Clinical Study Teams.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.