Study Coordinator - Johannesburg, South Africa - AJ Personnel

AJ Personnel
AJ Personnel
Verified Company
Johannesburg, South Africa

1 week ago

Thabo Mthembu

Posted by:

Thabo Mthembu

beBee Recruiter
Description

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 inperson or virtual training to manage the study
  • Assist study team with efficient study startup, conduct, and closeout
  • 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 onthejob 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 (passthrough, 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:

-
Professional Nursing Diploma with a Diploma in Oncology:

-
Recent Good Clinical Practice (GCP) and IATA Certification required

Required minimum work experience:

-
Minimum of 2 years of Oncology experience in a clinical trial environment

Professional body registration:


  • Registered with the South African Nursing Council (SANC)

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 studyrelated 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 decisionmaking
  • Ability to prioritize own workload, take initiative (proactive), and work to tight deadlines
  • Selfmotivated 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.
- _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.

Please note:

-
AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium
:

- **AJ Personnel does not have any salary or other information regarding the position.
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