O pozici
Conducts 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.
Co budeš dělat
- 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).
Koho hledáme
- A valid medical degree and registration within the country of practice
- A medical license in good standing, with unrestricted ability to practice in place of work, where applicable
- A valid ICH GCP certificate
- No 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.
- Good understanding of medical terminology, drug safety, and interpretation of lab reports
- Computer proficiency and confident in using Microsoft Office and other sponsor related programs and portals
- Good administration skills and a passion for quality and detail
- Comprehensive attention to detail
- Capable of working well under pressure and meeting deadlines
- Good understanding of commercial and financial concepts and the impact thereof on the business
- Capable of consistently working well with others and assisting in other areas as needed
- Capable of learning new processes and systems quickly
- Strong cognitive skills, with the ability to think, read, learn, reason, interpret and pay attention to detail in daily operations and tasks
- Capable of working independently
- Good prioritization and multitasking skills
