Clinical Research Associate II

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.

Job Description

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Language Requirement: Fluent English required. Spanish is a plus

Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology

Location: Sao Paulo Hybrid (2 to 3 days per week in the office)

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 2+ years of relevant Clinical Operations experience, and minimum of 1+ 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:

Provides site level management for established protocols and portfolio under general supervision

Provides mentoring/support to CRAs for CRA related topics

Co-monitoring with CRAs and support site visits, as needed

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