Senior Clinical Research Associate

BeiGene, Ltd.; São Paulo; Híbrido; BRL 180 000 - 300 000; Tempo integral

Resumo da oferta

BeOne in Sao Paulo, Brazil is seeking a Senior Clinical Research Associate to lead site monitoring activities for oncology trials in accordance with ICH-GCP guidelines. The role emphasizes building strong relationships with investigation sites, ensuring data integrity and patient safety, and providing ongoing training to staff.

The successful candidate will perform site visits, monitor data quality, and contribute to study milestones.

Qualificações

• BS/BA in a relevant scientific discipline with 3+ years in Clinical Operations.
• At least 2+ years of monitoring experience; oncology trials preferred.
• Fluent in English (writing and speaking) and excellent communication skills.

Responsabilidades

• Perform site visits and monitor data quality and patient safety per ICH-GCP and SOPs.
• Coordinate monitoring processes to assess safety and efficacy of investigational products.
• Develop relationships with investigative sites and study vendors; train site personnel.
• Mentor junior CRAs and share study-specific training with the team.
• Collaborate with CST to ensure timely milestones and provide audit/inspection support as needed.

Conhecimentos

Communication

Interpersonal skills

Organizational skills

Multitasking

English language

Formação académica

Bachelor's degree in a scientific field

Ferramentas

CTMS

MS Office Suite

Descrição da oferta de emprego

## Senior Clinical Research AssociateApply: São Paulo: Full time: Posted Today: End Date: October 11, 2026 (4 days left to apply): R37107BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.**Job Description****PLEASE SUBMIT ALL RESUMES/CV'S IN** ENGLISH **FOR CONSIDERATION** Language Requirement**:** Fluent English is Required Preferred Experience**:** Pharmaceutical/Biotech Industry, Hematology, Oncology Location**:** Sao Paulo General Description: The CRA will assume the role of a primary CRA. The CRA will conduct site visits (i.e., PSSV, SIV, IMV, COV) and function as the site manager. The CRA is responsible to build and maintain relationships with key site personnel and ensure an effective line of communication. The CRA will also monitor data quality and patient safety through monitoring and site education.CRAs are to complete all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs Essential Functions: * Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices* Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation* Develop collaborative relationships with investigative sites, and study vendors* Provide protocol and related study training to assigned clinical study sites* Attend disease indication and/or project specific training, as required* Maintain oversight of site performance by tracking metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issues* Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues* Communicate site performance to the Clinical Study Team (CST)* Perform study-specific training with project team* Perform Serious Adverse Event (SAE) reconciliation and work with study sites to resolve discrepancies* Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).* Attend regional investigator meeting and site booster visits, as required* Provide audit/inspection preparation support to clinical study sites and ensure quality issues or findings are followed to resolution, as needed* Assist with other assigned clinical responsibilities within scope of role, as required Minimum Requirements – Education and Experience: BS/BA in a relevant scientific discipline and minimum of 3+ years of relevant Clinical Operations experience, and minimum of 2+ years of monitoring experience. Experience in global oncology trials preferred. Other Experience: * Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines* Excellent communication and interpersonal skills* Excellent organizational skills and ability to prioritize and multi-task* Fluent in English (writing and speaking) Supervisory Responsibilities: Travel: Up to 70% travel Computer Skills: * Efficient in Microsoft Word, Excel, PowerPoint and Outlook* Familiar with industry CTMS and data management systems **#LI-Remote**