The CRA is responsible for providing the data on time and to the required quality standards, responsible for adhering to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering applicants, we look for highly motivated, collaborative, scientific and business professionals who share our passionate interest in the fight against cancer.
- The ARC performs oversight activities related to the initiation, conduct (recruitment, collection of quality data) and timely completion of oncology and pharmacy clinical trials in the country.
- The CRA is responsible for providing the data on time and to the required quality standards, and is responsible for adhering to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
- Carry out a follow-up (pre-study, initiation, routine follow-up and closing visit), if necessary
- Carry out co-monitoring visits, if necessary
- Performs quality control visits (QOV), as requested
- Complete surveillance / QOV visit reports in a timely manner
- Help identify the investigator / site
- Assists the site in preparing Ethics Committee submissions
- Facilitates the negotiation of contracts and budgets for clinical trial sites
- Manages site requests and communications
- Assistance in the management of clinical trials, if necessary
- Establishes regular lines of communication with sites and COMs
- Provide protocol and related study training to assigned sites
- Evaluates the quality and integrity of site practices – escalates quality issues, if any
- Manages site performance by tracking regulatory submissions, recruiting, case report form (CRF) completion, and resolution of data requests
- Bachelor’s degree or higher in life sciences, pharmacy, nursing or medicine
- Understands clinical trial processes with in-depth knowledge of ICH and associated regulatory guidelines
- 4 years or more of experience in surveillance in the pharmaceutical industry or CRO
- Excellent communication and interpersonal skills
- Excellent organizational skills and the ability to prioritize and multitask
- Fluent English (written and spoken)
- Applicant must have all working rights in New Zealand to be considered