Responsibilities:

• Read and understand the study protocol of the clinical trial project undertaken by company.
• Prepare all necessary files and documents required prior to conduct monitoring visits.
• Manages/ monitors investigative sites to ensure that all their clinical trial activities conform to the protocol as well as all applicable 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 site 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 diligent 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 report.
• Conducts study closeout visits. Ensures correct archiving of files on completion of a study