inVentiv Health Senior Clinical Research Associate (Hong Kong) in Hong Kong, Hong Kong
InVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With over 7000 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
DYNAMIC ENVIRONMENT. REWARDING CAREER.
Although inVentiv Health Clinical is one of the world’s leading providers of contract drug development services, we recognize you have a choice of where you seek employment. Here’s why inVentiv Health Clinical should be at the top of your list.
You will join a team of individuals who have the desire to excel in their fields, pursue excellence, and develop intelligent solutions by applying their knowledge and experience. Continuing professional development, personal incentive awards, competitive benefits, and opportunities can all be part of your career growth. Our culture is focused on internal communications and mutual respect for each other and our clients, and an absolute commitment to quality in everything we do.
We have great openings and opportunities across the South East Asia Region including; Singapore, Malaysia, Taiwan, Thailand and Hong Kong.
Title Senior Clinical Research Associate (Hong Kong)
Job ID 13851
Priority 1 - High
Perform routine site visits, including Pre-study, initiation, routine and closeout visits. Visits to include monitoring or proper informed consent procedures, compliance and assurance of good site performance
Document each visit with a quality written monitoring visit report and submit to the reviewer for review and approval within contractual guidelines
Author and send follow up letter to investigative site documenting the visit and any outstanding items to be addressed within contractual timelines
Review and approve monitoring visit reports ensuring finalization within contractual obligations
Assist Project Managers in study execution by acting as Lead CRA I projects and facilitating communication with Clinical Monitoring team
Perform monitoring evaluation visits with CRAs
Develop and facilitate training for colleagues on clinical, regulatory, administrative and company procedures and process
Develop study specific tools for tracking and reporting for Clinical Monitoring team
Participate in feasibility studies
Develop and write Clinical Monitoring Plans
Present study materials at investigator/study launch meetings when required
Support project management team with assessment of workload and site assignments within the project team
Assist project management team with review of monitoring reports and study documents when required
Participate in company required training programs
Participate on BID defense meeting
Perform necessary administrative functions ( e.g. submission of expense reports, entering time)
Train/Mentor junior CRAs on monitoring, internal procedures, and query resolutions.
Performed regulatory activities, if applicable
Bachelor’s Degree or nursing credential
Minimum four and a half years experience in clinical monitoring experience
Extensive knowledge of GCP/ICH Guidelines and other applicable regulatory requirements
Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus
Proven ability to work independently in a fast paced environment
Strong communication, interpersonal and organizational skills. Mentoring capabilities
Must demonstrate good computer skills
Ability to provide clear direction and guidance to other
Position requires approximately 60% travel
City Hong Kong
Country Hong Kong [HK]