Clinical Research Associate (All level)

About the role

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne , please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter). 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: General Description: The CRA executes clinical trial protocols at clinical trial sites and monitors clinical trials by ICH guidelines and GCP, local regulations, and applicable SOPs. The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials within the assigned region(country). Accountable for the study start-up timelines and delivery. Essential Functions of the job: Conducts monitoring (pre-study, initiation, routine monitoring, and closeout visit), if require Conducts co-monitoring visits, if required Assists with investigator/site identification Assists site to prepare Institutional Review Board/Ethics Committee (IRB/EC) 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 CSMs Provides protocol and related study training to assigned sites Evaluates the quality and integrity of site practices - escalating quality issues as appropriate Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. Performs QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for BeiGene studies Independently deliver clinical start-up component of assigned sites with accountability for time, cost and quality for assigned activities, which include, but not limited to, Investigator/Site identification, including conduct feasibility activity to identify investigators and conduct site visit to confirm qualification for the required study. Prepare, review, submit and QC submissions to Institution Review Board (IRB) to obtain clinical trial authorizations and approvals Prepare, review, and approve site level critical documents for IP release. Develop and finalize Country and Site-Specific ICFs. Perform site contract/ budget negotiation during start-up and maintenance phase. (If required) Review and finalize subject compensation rule and insurance as per local regulations. Review and translate subject recruitment materials as per local regulations if required. Assist CSMs in managing clinical trial during startup phase. Assist in maintain and update company-level investigator database. Establish, maintain and enhance relationship with key opinion investigators and sites. Proactively identify potential issues and seek improvement. Take initiative for issue resolution. Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans. Performs QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for BeiGene studies. Perform other duties as assigned by management Description for focusing on Japan: Supports to build Japan organization and required process such as Local SOP and WI. Supports rCSM to perform county activity for new studies if required. Conducts Site Motivation visits. Prepares and supports PMDA inspection. Other tasks, if needed. Supervisory Responsibilities: Not applicable Qualification Required: Education Required: BS in a relevant scientific discipline and at least 3 years or more (CRA) monitoring experience in the pharmaceutical or CRO industry Experience in oncology global trials preferred Computer Skills: Efficient in Microsoft Word, Excel, Outlook and other common software. Other Qualifications: Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines At least 3 years or more (CRAII) monitoring experience in the Pharmaceutical or CRO industry Excellent communication and interpersonal skills Excellent organizational s