Job Description
Position Purpose:
The purpose of the position is to monitor site data/source verification, and
upon trial implementation, oversee the execution of Good Clinical Practice
(GCP) practice of HCRISA trials at various Clinical Research Sites (CRSs) in
Southern Africa. This position is a trial monitoring resource for CRS staff and
other HCRISA Leadership Operations Centre (LOC) staff based in South Africa
and is a liaison between Southern Africa-based clinical CRS staff and the LOC.
Reporting to: Senior Site Liaison Manager or Lead Site Liaison Manager
KEY RESPONSIBILITIES
• Manage expectations for LOC, HCRISA Leadership, and CRSs related to study
implementation, including the start-up timeline, enrollment, and site performance.
• Prepares and presents study material at meetings and communicates outcomes to project
team.
• Responsible for ensuring that monitoring onsite and remotely is done in a timely manner as
per the monitoring plan.
• Work to carry out the operational strategy of the company.
• Represent and advocate for CRSs in strategic & operational discussions. Serve as the primary “go-to person” for CRS knowledge and CRS-related queries, with the manager's support.
• Drawing on knowledge and relationships with sites’ operations.
• Provides appropriate project tracking using computer-assisted programs and ensures up-to-date monitoring and resolution of any project issues as required.
• Review of site monitoring visit reports
• Completes all types of monitoring visits in accordance with relevant SOPs, regulatory
requirements and guidelines, the study protocol, project plan and clinical study monitoring
plan.
• Assist with preparation for site Audit/Inspection.
• Manage study site activities and provides ongoing site status updates to line manager.
• Manages risk and provides site support for the implementation of CAPA (Corrective Action and Preventative Action).
• Assists with the organisation of, and attends, study-specific training.
• Supports the compilation of Regulatory Authority and/or Ethics Committees submissions as required.
• Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.
• Provide training to the site on an ongoing basis to study-related procedures.
• Performed site monitoring and remote monitoring visits, site closures and monitored
according to ICH-GCP, South African Guidelines and SOPs.
• Performed source data verification, drug accountability, and query resolution.
• Report (Serious) Adverse Events; help prepare progress reports.
• Ensured sites met recruitment targets, maintain in-house and site study files.
• Other duties and assignments as requested for the overall performance of the department
and company.
• Other duties, as required
EDUCATION, CERTIFICATION, QUALIFICATIONS AND EXPERIENCE NEEDED
• Minimum of 5 years of onsite monitoring experience
• Degree or equivalent qualification in public health, life sciences, or medical field
• Clinical trial monitoring and audit/inspection readiness experience
• Senior Clinical Research Associate experience monitoring in South Africa and other African
countries.
• An equivalent combination of education and experience may be accepted.
• A thorough understanding of site monitoring and working independently at the site.
• Understanding of clinical trial conduct in limited-resource settings, and of regulations as they relate to clinical trials
COMPETENCIES /SKILLS/ KNOWLEDGE
• Site Advocate
• Working independently
• Goal Oriented
• Problem-solving skills
• Capacity Coordination and prioritizing skills
• Clinical Research Expertise
• Local regulatory requirements knowledge
• Good communication and interpersonal skills
• Attention to detail
• Flexibility – able to travel internationally and within South Africa, and able to work after
traditional business hours for communication with international colleagues and sponsors.
• Effective presentation skills to ensure information is clear and understandable
• Takes initiative and works independently
• Good time management and works within set deadlines
• Flexible and adaptable to the changing needs of a dynamic environment
Should you be interested in applying for this vacancy, submit your application online: https://southafrica-fhcrc.icims.com/jobs/search5770326