Job Descriptions:

• Reads and understands the study protocol of the clinical trial project undertaken by the company.
• Prepares all necessary files and documents required prior to conducting monitoring visits.
• Manages/monitors investigative sites to ensure that all of the clinical trial activities conform to the protocol as well as applicable to the ICH/GCP guidelines, regulations and SOPs.
• Conducts study qualification visits for the purpose of assessing the site’s ability to affectively conduct the trial as per SOPs and study guidelines.
• Assists investigator meeting including preparation, liaison, presentations, problem resolutions, and follow up.
• Conducts study initiation visits for the purpose of reviewing and training site personnel as per SOPs and study guidelines.
• Ensure timely submission of protocol/consent documents for EC/IRB approval.
• Maintains all files and documentation pertaining to studies.
• Motivates investigators in order to achieve recruitment targets.
• Maintaining regular contact with study sites to ensure protocol/GCP compliance. Provides appropriate verbal and written feedback to site, listing overall performance, deficiencies and corrective action required.
• Communicates progress of study and relevant information to Project Manager/Sr. CRA and other project team members.
• Completes accurate study status reports in time.
• Ensure proper storage of drugs and the diligence account of all drugs in accordance with SOPs.
• Deals with Case Report Form (study data) queries in a timely manner.
• Participates, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines, and elements of final reports.
• Conducts study closeout visits. Ensures correct archiving of files on completion of a study.

Job Requirements:

• Fresh graduates in biotechnology, medical science, or science-related are encouraged to apply.