Clinical Research Associate I

Clinical Research Associate I – Beigene – São Paulo, Brasil PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION. Language Requirement: Fluent English and Portuguese. Spanish is a plus. Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology. Company Overview BeiGene, Ltd. (NASDAQ: BGNE; HKEX: *****) is a global, commercial‑stage, research‑based biotechnology company focused on molecularly targeted and immuno‑oncology cancer therapeutics. With a team of over 10,000 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland, Australia and Brazil, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. General Description The CRA I is responsible for completing the BeiGene CRA Training Program (****** weeks) prior to assignment as a primary CRA. The training program consists of instructor‑led training sessions, independent exercises, and in‑field observation visits. After successful completion, the CRA will assume the role of a primary CRA, conduct site visits (PSSV, SIV, IMV, COV), and function as the site manager. Essential Functions Complete required elements of the CRA training program and meet all outlined deadlines. 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 per monitoring plan and applicable SOPs. 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. Communicate site performance to the Clinical Study Team (CST). May serve as mentor/trainer for less experienced CRAs to assist with general and study‑specific monitoring issues. Perform study‑specific training with project team. Perform Serious Adverse Event (SAE) reconciliation and work with study sites and CST to resolve discrepancies. Collaborate with CST and clinical study sites to ensure timely delivery of study milestones (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 the role, as required. Minimum Requirements – Education and Experience BS/BA in a relevant scientific discipline. Experience working in oncology global trials and 5+ years of relevant Clinical Operations experience. Or 1+ year in a clinical research associate position is preferred. Other Qualifications 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 assigned study sites. Co‑monitoring with CRAs and supporting site visits, as needed. May serve as a mentor CRA for CRAs in training. Travel: Up to 70% travel. Computer Skills Proficient in Microsoft Word, Excel, PowerPoint and Outlook. Familiar with industry software such as CTMS, investigational product and data management systems. LI‑Remote BeiGene Global Competencies 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 We are proud to be an equal‑opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other… #J-18808-Ljbffr