Description:
Main purpose of the job:The project manager/study coordinator is responsible for coordinating all clinical trial activities according to good clinical practice, the study protocol and the site standard operating procedures Location:
Wits RHI Lejweleputswa (Free State) Key performance areas:
Oversee all operations in the clinical trial to ensure protocol and GCP compliance Assist study team with efficient study start-up, conduct and close-out Manage regulatory updates throughout the study (New ICFs, Protocol Amendments, etc.) Proactively resolve protocol queries and missing data with Investigators and Clinical Trials Assistants Communicate with CRO, Sponsor and regulatory authorities regarding notifiable trial events Prepare for and manage participant visits and data capturing in line with protocol and site SOPs Perform and/or book procedures correctly per protocol within scope of practice Assist in patient recruitment, screening, and enrolment of eligible patients according to protocol requirements Compliance to all relevant SOPs Communicate well with investigators regarding participant welfare while on study Notify relevant parties of Serious Adverse Events or Events of Medical Importance as per protocol requirements. Quality control of patient files and data entries (i.e., eCRFs, CRFs) Attend Investigator meeting, SIV and any other key meetings to manage the study Manage site monitoring visits/audits or similar Manage procurement for the study Assist team members and support teams with an open helpful attitude, perform on-the-job training where necessary Assist the team with ad hoc assignments and duties as needed, delegated by line manager and within scope of practice Manage and support staff members Required minimum education and training:
Degree in Health-Related Field Required minimum work experience:
3-5 years experience in clinical trials/research Desirable additional education, work experience and personal abilities:
Masters degree in a health-related field Work experience in sexual and reproductive health care Experience in Network studies Thorough with good attention to detail Valid drivers license Ordered and systematic in approach to tasks, with strict compliance to protocols Exceptional organisational and administrative skills are required together with working knowledge of Microsoft Office Able to exercise discretion and independent decision-making Ability to prioritise own workload, take initiative (pro-active) and work to tight deadlines Self-motivated with a h
02 Mar 2025;
from:
gumtree.co.za