Join Us as a Clinical Research Associate

At Klinsel, we are committed to delivering excellent services to our clients and are passionate about quality. In this fast paced and ever-growing industry of clinical research, there is a great demand for individuals with the right attitude, experience, skills, and knowledge – just like YOU.

We value our employees as we realise that our greatest assets are the skills and talents of our staff. We are also committed to professional growth and development, realising that continuous advancement in one’s career is of great importance. Hence, we believe in providing opportunities for you to grow and advance your skills and knowledge through structured internal and external training, on-the-job learning, and mentoring.

Job 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.

Job Requirements:

• Possess at least a Bachelor’s Degree in Biotechnology, Medical Science, Life Science, or any related field.
• Strong organisational skills.
• Meticulous, attention to detail.
• Able to work independently to meet deadlines.
• Excellent communication (verbal and written) and interpersonal skills.