Study Coordinator

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 Sponsors

Location:

• PHRU – Chris Hani Baragwanath Hospital, Soweto - Johannesburg

Key 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 them

Required minimum education and training:

• Degree/Diploma in Nursing
• Qualified as a Professional Nurse
• Valid Drivers License with PDP
• GCP Certificate

Required 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:

• Registered with the South African Nursing Council

Desirable additional education, work experience, and personal abilities:

• Current Good Clinical Practice (GCP) Certification
• Computer literacy – competence in MS Word and Excel essential
• Good planning, organizing, and delegation skills
• Able to exercise discretion and independent decision making
• Attention to detail
• Ability to work under pressure
• Willingness to travel, have a valid driver’s license, and drive currently

TO APPLY:

• Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
• Please take note that the applicants who do not adhere to the above requirements will not be considered for the respective position.
• 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.
• The closing date for all applications: 25 February 2025.
• 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 and response handling of the advertisement on behalf of their client Wits Health Consortium.
• AJ Personnel does not have any salary or other information regarding the position.
• Wits Health Consortium will only respond to shortlisted candidates.
• Candidates who have not been contacted within two weeks from the closing date can consider their application to be unsuccessful.