Study Coordinator

Main purpose of the job:
To administer, maintain and coordinate the logistical aspect 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 the sponsor.

Location:
Helen Joseph Hospital, Johannesburg

Key performance areas:
Assist in recruitment, Screening and Enrolment of eligible participants according to Protocol requirements.
Assisting in the recruitment and consenting and enrolment of study participants
Assist the Medical Officers/ Principal Investigator, and Study team in the day-to-day running of the study
Manage scheduled and unscheduled patient visits and appointments in accordance with study protocol
Conduct protocol, SSP, and SOP training for staff
Liaise with the CHRU regulatory department for the reporting if SAEs and protocol deviations etc
Liaise with the Sponsor, Laboratory, Pharmacy and external monitoring contractor
Perform participant’s vitals (as and when required) and direct patients to relevant assessment.
Assist with study specimen collection (i.e. blood, urine, sputum, cervical specimens and semen).
Collect process and ship specimens as per protocol.
Administering trial medications and diagnostic tests if required
Completion of Source Documentation
Complete relevant research questionnaires, assessments, CRF transcription.
Review of participant files for completeness
Maintain and update the Investigator Site File
Site supervision and management

Required minimum education and training:
Registered as a Professional Nurse with the South African Nursing Council with 3 years’ experience in a clinical research
environment
2 years project management experience

Desirable additional education, work experience and personal abilities:
Computer literacy – competence in MS Word and Excel essential
Staff supervisory and management experience
The ability to speak local languages
Able to exercise discretion and independent decision making
Empathy and Understanding