Senior Clinical Research Associate

Beigene; São Paulo; Vor Ort; BRL 120.000 - 180.000; Vollzeit

Zusammenfassung

BeOne is seeking an experienced Clinical Research Associate (CRA) to serve as the primary CRA, conducting site visits (PSSV, SIV, IMV, COV) and acting as the site manager. You will build relationships with investigative sites and ensure effective communication.

You will monitor data quality and patient safety in line with ICH-GCP guidelines and SOPs, and support regulatory compliance and site education throughout monitoring of oncology trials.

Qualifikationen

• BS/BA in a relevant scientific discipline and 3+ years in Clinical Operations.
• Minimum 2+ years of monitoring experience.
• Experience in global oncology trials preferred.
• Fluent in English (writing and speaking).

Aufgaben

• Perform and coordinate aspects of the clinical monitoring process per GCP/SOPs.
• Conduct site visits to ensure protocol and regulatory compliance and prepare documentation.
• Develop relationships with investigative sites and study vendors.
• Provide protocol and study training to site personnel.
• Attend disease indication and project-specific training as required.
• Track enrollment, data entry, deviations, and site performance metrics.

Kenntnisse

Fluent English

Excellent communication

Organizational skills

Team collaboration

Travel readiness

Ausbildung

BS/BA in a relevant scientific discipline

Tools

CTMS

Microsoft Office

Jobbeschreibung

Job Description

BeOne 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.

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

Global Competencies

• When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Equal opportunity statement

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.