Description:
Main purpose of the job:
To administer, maintain and coordinate the logistical aspects of clinical trials according to Good Clinical Practice, Study Protocol, and Standard Operating Procedures and to act as a pivotal point of contact for the clinical trial team and SponsorsLocation:
PHRU – Chris Hani Baragwanath Hospital, Soweto - JohannesburgKey performance areas:
Assist the Principal Investigator and study team in the day-to-day running of the research sites Must ensure they have good knowledge of the protocols, standard operating procedures and study specific procedures Ensure the performance of trial related duties in the various studies are in accordance with GCP Ensure site has adequate study supplies Ensure logbooks are up to date Plan daily recruitment and assess whether daily targets are being met Ensure all study equipment is calibrated as per requirements Implement, evaluate and supervise strategies to maximise recruitment and retention Manage participant schedules in accordance with study protocols Ensure the site's investigator files are up to date and maintained according to sponsor and regulatory requirements Ensure availability of study documents and tools to facilitate accurate data collection QC of all ICFs and data entered, source vs data review Ensure that study data is captured accurately and in a timely fashion Participate in and oversee site activities that ensure data integrity Conduct protocol and site required trainings and ensure all site staff have been trained appropriately and are updated with any new information Ensure that all study staff training is documented and up to date Ability to work independently as well as be part of a multidisciplinary team Able to step in for any staff member who cannot perform their duties i.e. another Nurse/Recruiter Review and oversee petty cash submissions and process to finance to ensure all is in order Respond to queries generated by the Data Manager and help staff resolve themRequired minimum education and training:
Degree/Diploma in Nursing Qualified as a Professional Nurse Valid Drivers License with PDP GCP CertificateRequired minimum work experience:
Minimum of 5 years’ experience in a clinical research environment At least 3 years prior experience as a Study Coordinator or Project Coordinator in clinical studies Minimum of 2 years’ experience working in multiple/across studies with cross functional activities Professional Body Registration:
13 Feb 2025;
from:
gumtree.co.za