CRAII - SCRA (NZ wide & Home-based) About the company: BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 8,500 employees across the United States, China, Europe and Asia Pacific region, 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. Job Description: The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Hematology clinical trials within the country. The CRA is responsible to deliver data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs. How you will add value: Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if required. Conducts co-monitoring visits, if required. Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.). Attends onboarding-, disease indication and project specific training and general CRA training as required. Documents monitoring activities appropriately following ICH-GCP and BeiGene standards. Conducts Quality Oversight Visits (QOV), as requested. Completes monitoring visit/ QOV reports timely. Assists with investigator/site identification. Assists site to prepare Ethics Committee submissions. Facilitates clinical trial site contract and budget negotiation. Manages site queries and communications. Assists in managing clinical trials, if required. Establishes regular lines of communication with sites and COMs. Provides protocol and related study training to assigned sites. Evaluates the quality and integrity of site practices – escalating quality issues as appropriate. Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution. Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed. Performs additional tasks as assigned. Qualification Required: What we expect from the successful candidate: Bachelor's level degree or above in life sciences, pharmacy, nursing or medical. Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines. +1 year (Over 4 years for SCRA) of monitoring experience in the pharmaceutical or CRO industry. Excellent communication and interpersonal skills. Excellent organizational skills and ability to prioritize and multi-task. Fluent in English (writing and speaking). Applicant must have full Australian working rights to be considered. What we offer to our valued employees: Market competitive compensation package including performance-based annual bonus scheme. Company shares (generous welcome grant and performance-based annual equity plan!). Full-time working from home. In-house and external learning and development opportunities. Fantastic benefits program as per the current policy including: Personal health insurance reimbursement. Home-office setup allowance. Monthly reimbursement for home office expenses (i.e. internet, mobile). Group life insurance & income protection insurance. Wellness benefits (Employee Assistance Program). Active social club. And more as the benefit programs keep improving! Plus you get to work with a dynamic team of collaborative, supportive, diverse and fun professionals whose mission is clear: Cancer has no borders and neither do we. BeiGene is proud to be an Equal Opportunity Employer: 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 basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Covid-19 policy: As part of the job requirements, all site-facing roles (i.e. a role that requires attendance at clinical sites as part of their job) are required to be fully vaccinated for COVID-19, according to their current clinical site health and safety protocol. #J-18808-Ljbffr