Global studies and clinical trials.
Promising and growing organization.
About Our Client
My client is one of the promising and growing glocal CRO company, who focus on Asia-pacific area development. Their cultural foundation is built on the attributes of collaboration, accountability, trust, innovation and most importantly, professional advancement for our people. They are looking for working with the senior CRA 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/Work Instructions 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.
The Successful Applicant
- BS degree in science/health care field or nursing degree or equivalent combined education and experience.
- At least 2 year CRA with oncology experience in clinical research associate role.
- Moderate understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines.
- Model professional communication in both written and verbal interactions.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
What's on Offer
- Great career development plan.
- Opportunities to relocate to other APEC offices.