Job Description

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 is in accordance with GCP
• Ensure the site has adequate study supplies
• Ensure all study equipment is calibrated as per requirements
• Ensure appropriate specimen handling
• Implement, evaluate, and supervise strategies to maximize 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 the availability of study documents and tools to facilitate accurate data collection
• 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 training 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
• Liaise with the PHRU regulatory department in ensuring adherence and compliance to regulatory requirements in all active site activities
• Liaise with the Sponsor, Laboratory, Pharmacy, external monitoring contractors, and other stakeholders such as the DoH
• Prepare and submit reports to the relevant sponsors, donors, collaborators, regulatory authorities, and other relevant stakeholders in a timely fashion
• Ensure that the contractual documents required for study implementation are in place and valid
• Employ financial acumen in areas including budgeting and expenditure
• Ability to work independently as well as be part of a multidisciplinary team

Required minimum education and training:

• Grade 12
• Degree/Diploma in Nursing
• Qualified as a Professional Nurse
• Valid Drivers License
• 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
• Pays 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 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.
• 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: 26 August 2024.
• 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