Overall accountability for the operational conduct of assigned studies, working closely with the Project Manager, Principal Investigator and operational staff and ensuring that all studies are conducted in accordance with regulatory and protocol requirements, and standard operating procedures whilst maintaining the safety and integrity of the study.
The Clinical Research Coordinator is the primary site contact for the Project Manager (PM) communicating any potential issues and assists in taking appropriate action in response to these issues, ensuring that client requirements and timelines are always met or exceeded.
Independently undertakes routine studies and more complex studies with guidance. May coach and mentor Operations coordinators and junior staff.
Study Set-up Performs all aspects of the set up process to include the development and approval of study specific documents, study schedules and clinical procedure planning
Protocol Review Reviews protocols, provides consolidated comments from the clinical site on the draft study protocol to the Project Manager or Medical Writer, taking into account the logistics, safety (staff and study participants), and site's capabilities. May distributes final protocols and amendments to the site
Knowledge of protocol designs, study objectives and study procedures
Knowledge of drug development process, ICH guidelines and GCP
Excellent written and oral communication skills
Ability to prioritize workloads
Good organizational skills
Previous customer service experience desirable
Previous experience of coordinating people or processes desirable
University/college degree desirable (life science, pharmacy or related subject preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification, medical or laboratory technology).
In lieu of a degree, typically 3 years' experience in a related field will be considered