Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob DescriptionConducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol and company processes. Ensures the medical wellbeing and safety of the participants through the safe performance and execution of the studies. Maintains clinical oversight and quality on the studies registered on and delivers on study targets, thereby contributing to the commercial success of the site which includes: recruitment, enrolment and retention of study participants.This will be working on a DCP contract - maximum 20 hours per weekDay to day responsibilities:Carries out clinical evaluation and assessment of participants to ensure eligible participants are enrolled onto studies.Reviews enrollment progress, pre-screening and screening success rates, screen failure rates, safety and retention of participants.Interprets protocols and IB and participate in initiatives to strategize for patient recruitment.Ensures and protect the welfare and safety of participants through ethical conduct; this should receive the highest priority at all times during all aspects of the study.Fulfills and comply with all medical duties as per protocol, SOP/COP and ICH GCP and local regulations.Reports any safety threats, that may impact stakeholders/participants and action complaints or QIs as per site processes.Exercises meticulous attention to detail in recording information and source management.Actively involved in audit preparations and site inspections.Oversees the management of investigational medical product (IMP).Qualifications: Education and Experience:A valid medical degree and registration within the country of practiceA medical license in good standing, with unrestricted ability to practice in place of work, where applicableA valid ICH GCP certificateNo previous experience in clinical research years of required, but must have general medical practitioner diagnosis and treatment proficiency In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:Good understanding of medical terminology, drug safety, and interpretation of lab reportsComputer proficiency and confident in using Microsoft Office and other sponsor related programs and portalsGood administration skills and a passion for quality and detailComprehensive attention to detailCapable of working well under pressure and meeting deadlinesGood understanding of commercial and financial concepts and the impact thereof on the businessCapable of consistently working well with others and assisting in other areas as neededCapable of learning new processes and systems quicklyStrong cognitive skills, with the ability to think, read, learn, reason, interpret and pay attention to detail in daily operations and tasksCapable of working independentlyGood prioritization and multitasking skills
