Our client conducts phase I-IV clinical trials for pharmaceutical and biotechnology companies all over the world. You will be exposed to various therapeutic areas and sponsor clinical trial studies from all over the world.
Your key responsibilities will be:
- Coordinate clinical trial activities to meet sponsor expectations and timelines and ensure all studies are in compliance with relevant SOPs, policies, and regulations.
- Prepare and co-ordinate submissions to ethics committee in collaboration with project managers and study start-up specialists.
- Assist in the management of study expenses within allocated budget and development and coordination of study related training for relevant staff.
- Create or review worksheets to capture data for the CRFs and ensure timely entry of clinical data into the CRF to the highest qualtiy standards.
- Conduct routine clinical procedures during screening and in the ward (e.g. vitals, ECG, blood collection and other study assessment) as required.
To be successful in this role you will have:
- Demonstrated experience and skills in clinical research study coordination and management.
- Sound knowledge of the principles of ICH-GCP.
- Availability for flexible working hours (i.e. early morning starts, after hours and weekends)
- Excellent organizational and interpersonal skills; including the ability to competently liaise with feedback to internal and external collaborators regarding project issues and company decisions.
- Commitment to quality and high attention to detail.
- Excellent computer literacy.
- Preferably, experienced in standard clinical assessment techniques (e.g. vital signs, ECG, blood collection, venipuncture) and/or laboratory technique (processing of blood and urine, centrifugation, pipetting, etc.)
You will be surrounded with professionals who are highly experienced in the clinical trials industry and this is an exicting opportunity to learn from the best.