Study Coordinator (SCO) - East London at Desmond Tutu Health Foundation

The main purpose of this position is for Study Coordinator (SCO) functions under the supervision of the CRS Leader with input from the Principal Investigator to coordinate a specific research study as required. The SCO is responsible for the successful execution of clinical trials. The responsibilities involve coordinating various aspects of the trial to ensure it is conducted efficiently, ethically, and in compliance with regulatory guidelines. On-site project coordination activities associated with the efficient collection of data. The role includes general study administration, staff supervision, training, and data management with the scientific and clinical guidance from the PI.

Minimum Requirements:

• Tertiary Degree in Health-related field with an active SANC registration
• Minimum of 2 years working experience in a similar/same role in a research environment
• Minimum of 5 years nursing experience
• NIMART certification (theory and practical)
• Knowledge of HIV and adherence issues
• Working knowledge of clinical trial software/databases
• Knowledge of South African Good Clinical Practice with a valid GCP certificate
• Must speak English and isiXhosa
• Demonstrated experience in project co-ordination
• Knowledge of compliance to Ethics and regulatory documentation
• Quality Assurance and Quality Control skills, including drafting Standard Operating Procedures (SOP’s)
• Monitoring and Evaluation skills
• System implementation and maintenance of existing functional systems
• Ability to generate reports of at different time points
• Highly functional computer Literate (Proficiency in Ms Excel, Ms Word, Ms Office package)
• High functional administration and organisational skills
• Attention to detail 
• Strong problem-solving and decision-making abilities
• Ability to work under pressure
• Staff Management
• Ability to work independently and part of a team
• Valid driver’s license and willingness to travel independently between public clinic facilities

Responsibilities:

Clinical Trial Management

• The successful implementation and execution of Clinical Trial protocols
• Management of clinical trials from start-up through to close-out
• Responsible for staff training and oversight, of clinical trials.
• Responsible for data collection and other administrative tasks
• Oversight of the informed consent process and storage of the completed documents
• Monitoring the progress of ongoing research activities, recruitment and retention as well as all study procedures
• Understand and be able to complete all data entry processes including paper and electronic case report forms.
• Assist data team in data entry, maintenance of devices as required.
• Oversight of the flow of participants through the clinic by liaising with pharmacy, lab and clinical staff
• Conduct all work in compliance with internationally recognized ethical standards.
• Ensure all AE’s and SAE are reported as per protocol
• Responsible for oversight of clinical expenses for external services
• Responsible for arranging external patient services, where required
• Provide strategic oversight throughout the lifecycle of clinical trials, identifying areas for improvement, and implementing innovative solutions for enhanced trial management
• Ensure that the Mobile Truck (clinic) is maintained and fully operational at all times

Quality Management

• Establish and maintain investigator site, study files and documentation according to ICH/GCP guidelines.
• Maintain study logs (screening, enrollment etc.)
• Conducting QC and ensuring QA for selected trials
• Awareness of study budget and line items
• Assist data team in maintenance of tablets and electronic devices as required
• Oversight of Regulatory process
• Conduct all work in compliance with internationally recognized ethical standards
• Attend to monitors/auditors queries and visits
• Prepare/update all documents and procedures for network audits

Study procedures and study-co-ordination

• Develop ICF’s and all source docs with PI
• Obtain informed consent, as needed
• Completion of ongoing study activities and clinical study procedures
• Oversight of study procedures as per protocol
• Assist with participant procedures where required and can be a back-up for the study nurse
• Ensuring sufficient staff coverage for after-hour participant care
• Arrange for additional participant care as required

Staff Management

• Training of junior staff
• Line- Management of staff
• Hold regular meetings with study staff to facilitate good team dynamics and to enable good oversight of studies.