CRA II
Guangzhou, Guangdong, China
DUTIES AND RESPONSIBILITIES
- Acting as the main line of communication between the sponsor and the investigator. Maintain good relationship with site staff.
- Assist to prepare site level documentation, such as forms, templates document receipt, etc..
- Provide study related training to site staff; notify investigators of pertinent protocol changes.
- Assist site staff to perform the Ethics Committee submission.
- Contribute to Investigator meeting and other study meetings.
- Conduct site selection and site qualification evaluation. Verify the qualification and resources of site staff and site facilities.
- Conduct monitoring activities at study site. Verify informed consent forms, medical record, other source documents, investigational products and equipment. Make sure the site conducts the study based on protocol requirement.
- Verify the eligibility of enrolled subjects.
- Conduct the Source Documentation Verification (SDV) to check the accuracy and completeness of the CRF.
- Verify the safety events occurred at site, and make sure all the events are reported appropriately.
- Verify the essential documents, make sure the documents are well maintained and updated.
- Identify deviations from protocol, SOP, GCP and applicable regulatory requirement, and report to study team in a timely manner.
- Identify any issues and risks site may have, and report to study manager in a timely manner.
- Resolve issues independently.
- Conduct site initiation visit and close-out visit.
- Complete monitoring visit report within required timeline.
- Ensure compliance with company policies and procedures of finance, IT and administration.
- Provide training or coaching to junior CRA.
- Performs other related duties as assigned by line manager.
QUALIFICATIONS
- Bachelor degree or above in clinical medicine or related fields.
- At least 3 years CRA experience in phase I to III clinical trials, phase II or III study experience is a must.
- Proactive communication and team interaction with site staff and study team members.
- Fluent English skill on speaking, reading and writing.
- Nice to have NMPA inspection experience.
- Familiar with GCP and the local laws and regulations related with clinical research.
- Ability to travel as required.
- Ability to work independently and manage time well.
- Identify problems in a timely manner.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Brii Biosciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. We value diversity and are committed to creating an inclusive environment for team members from all backgrounds.