Job 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's standard operating procedures

Location:

• 22 Esselen Street, Hillbrow, Johannesburg

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 the scope of practice
• Assist in patient recruitment, screening, and enrolment of eligible patients according to protocol requirements
• Compliance with 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 meetings, 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 the line manager and within the scope of practice
• Manage and support staff members

Required minimum education and training:

• Degree or Honours Degree in a 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 organizational and administrative skills are required together with working knowledge of Microsoft Office
• Able to exercise discretion and independent decision-making
• Ability to prioritize own workload, take initiative (pro-active), and work to tight deadlines
• Self-motivated with high regard for work ethic, values, and integrity
• Overtime and traveling will be required from time to time
• Light physical activity is required

TO APPLY:

• Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
• Please Apply Online.
• Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
• The closing date for all applications: 30 July 2024.
• Note AJ Personnel is fully POPI compliant.
• Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.

Please note:

• AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
• Wits Health Consortium will only respond to shortlisted candidates.
• Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.
• AJ Personnel does not have any salary or other information regarding the position.

AJ Personnel