SeniorCRA with Global CRO
Global studies and clinical trials.
New created headcounts.
About Our Client
My client is one of the promising and a well-established glocal CRO company. Their cultural foundation is built on the attributes of collaboration, accountability, trust, innovation and most importantly, professional advancement for human beings. They are looking for working with the senior CRA/ CRAII who has passion in science and research industry, would like to keep developing himself/herself with the company.
- Performs monitoring functions to assess the progress of clinical studies at assigned investigative sites to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures, ICH-GCP, and all applicable regulatory requirements.
- Completes and submits monitoring visit reports in accordance with SOP or Sponsor requirements as agreed in the scope of work.
- Ensures all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools.
- Maintains site performance metrics with guidance and implements action plans for sites not meeting expectations with limited guidance.
- Maintains up to date information within the deployed Clinical Trial Management System.
- Assigned therapeutic areas are not limited to oncology, and you will have the opportunities to handle projects of multiple disease areas.
The Successful Applicant
- BS degree in science/health care field or nursing degree or equivalent combined education and experience.
- At least 3 year CRA experience in CROs or pharmaceutical companies.
- Moderate understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines.
- Professional communication in both written and verbal interactions in English and Chinese.
- Ability to handle multiple tasks to meet deadlines in the dynamic environment.
What's on Offer
- Great career development plan.
- Competitive salary package.