Senior Clinical Research Associate
- Beijing
- Permanent
- Full-time
- Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits.
- Act as the main line of communication between project team, Sponsor and the site -Ensure that subject recruitment targets and project timelines are met at site level.
- Perform CRF review, source document verification, drug accountability, and query resolution.
- Facilitate the flow of site documents, assist in maintaining study-specific and corporate tracking systems.
- Support Study Startup and Regulatory teams in preparation of draft regulatory and ethics committee submission packages.
- Conduct project-specific training of Investigators, prepare Investigator newsletters.
- Participate in study site audits and client onsite visits, as required.
- Monitor project timelines and patient enrollment, implements respective corrective and preventive measures.
- Support junior Monitors in the query resolution process, including Central Monitoring observation.
- Coordinate safety information flow and protocol/process deviation reporting.
- Perform clinical supplies management with vendors.
- Support site contracting and payments.
- May lead project team calls on a country level.
- College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience.
- Substantial independent on-site monitoring experience.
- Experience in all types of monitoring visits in Phase II and/or III -Experience in feasibility assessment and study set-up process is preferable.
- Experience in Oncology therapeutic indications is a plus (preferable).
- Full working proficiency in English.
- PC skills to be able to work with MS Word, Excel and PowerPoint Ability to plan, multitask and work in a dynamic team environment -Communication, collaboration, and problem-solving skills.
- Ability to travel.