Study Coordinator (Nurse/Oncology) Wits WCR - - Johannesburg

Main purpose of the job:

To administer, maintain, and coordinate clinical trials according to good clinical practice, the study protocol, and the site standard operating procedures
Act as a pivotal point of contact for the clinical trial team and the study sponsor(s)

Location:

32 Princess of Wales Terrace, Parktown/17 Eaton Road/Charlotte Maxeke Johannesburg Academic Hospital/ Chris Hani Baragwanath Academic Hospital, Soweto

Key performance areas:

Study Management

Primary SSC on trial to oversee all operations on trial, ensure protocol and GCP compliance
Attend Investigator meetings, SIV, and any other in-person or virtual training to manage the study
Assist study team with efficient study start-up, conduct, and close-out
Ensure access to online portals for self and support staff
Manage regulatory updates throughout the study (New ICFs, Protocol Amendments, etc.)
Manage site monitor visits according to GCP and Site SOP
Proactively resolve protocol queries and missing data with Investigators and Clinical Trials Assistants
Communicate with CRO, Sponsor, and regulatory authorities regarding notifiable trial events

Participant Management

Prepare for and manage participant visits and data capturing in line with protocol and site SOPs
Assist in patient recruitment, screening, and enrolment of eligible patients according to protocol requirements
Perform and/or book procedures correctly per protocol within the scope of practice
Manage lab kits and study samples according to protocol, procedures manual, and local legislature
Administer study medication safely in line with the scope of practice
Be able to manage medical emergencies within the scope of practice
Communicate well with investigators regarding participant welfare while on study
Notify relevant parties of Serious Adverse Events or Events of Medical Importance within 24 hours
Quality control of patient files and data entries (i.e., eCRFs, CRFs)

Teamwork & Support

Assist team members with an open helpful attitude, perform on-the-job training where necessary
Assist the Pharmacist with visit activities (IVRS, IP management, etc.)
Assist the administrative staff with arrangements to be made for participant visits (Patient transport with Uber, Vendor booking details, etc.)
Assist site finance staff with payments on the study (pass-through, travel fees, etc.)
Assist the team with ad hoc assignments and duties as needed, delegated by the line manager, and within the scope of practice

Required minimum education and training:

Required minimum work experience:

Professional body registration:

Desirable additional education, work experience, and personal abilities:

Good communication skills both written and verbal
Thorough with good attention to detail
Must be computer proficient to manage online study systems
Must be able to process and ship study-related lab samples
Phlebotomy skills and the ability to perform an ECG are necessary
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 may 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 and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate to accept the new POPIA terms and conditions. This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL. However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market.
AJ Personnel is fully POPIA Compliant.
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: 16 April 2024.
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.

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.

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