Clinical Research Associate II
BeiGene
Summary
The CRA will assume the role of a primary CRA, conducting site visits (PSSV, SIV, IMV, COV) and functioning as the site manager. The CRA is responsible for building and maintaining relationships with key site personnel and ensuring an effective line of communication. The CRA will also monitor data quality and patient safety through monitoring and site education. CRAs complete all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
Job description
General Description
The CRA will assume the role of a primary CRA, conducting site visits (PSSV, SIV, IMV, COV) and functioning as the site manager. The CRA is responsible for building and maintaining relationships with key site personnel and ensuring an effective line of communication. The CRA will also monitor data quality and patient safety through monitoring and site education. CRAs complete all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
Essential Functions of the Job
- 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
- 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 role, as required
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
Computer Skills
- Efficient in Microsoft Word, Excel, PowerPoint and Outlook
- Familiar with industry CTMS and data management systems
Other Qualifications
- 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)
Travel
Up to 70% travel.
Education Required
- 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
Requirements
- BS/BA in a relevant scientific discipline
- Minimum of 2+ years of relevant Clinical Operations experience
- Minimum of 1+ years of monitoring experience
- 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)
- Efficient in Microsoft Word, Excel, PowerPoint and Outlook
- Familiar with industry CTMS and data management systems
- Experience in global oncology trials preferred
Benefits
- Medical, Dental & Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Annual bonus plan
- Incentive compensation plan
- Discretionary equity awards
- Employee Stock Purchase Plan
Company overview
BeiGene, Ltd., now rebranding as BeOne Medicines, is a global commercial-stage biotechnology company specializing in the discovery, development, manufacturing, and commercialization of innovative oncology medicines. Founded in 2010 by John V. Oyler and Xiaodong Wang, the company has grown into a multinational organization with headquarters in Cambridge, Massachusetts, Beijing, China, and Basel, Switzerland. BeiGene focuses on developing targeted and immune-oncology therapies for cancer treatment, with a diverse pipeline that includes internally discovered products like BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor, and Tevimbra (tislelizumab), a PD-1 inhibitor. The company operates across six continents with over 45 countries participating in clinical trials and has enrolled more than 30,000 patients in its research programs. With approximately 12,000 employees worldwide, BeiGene has established itself as a significant player in global oncology, particularly with strong market presence in China and expanding operations in the United States and Europe. The company's mission centers on expanding access to high-quality cancer therapies worldwide through persistent innovation and challenging traditional approaches to drug development.