Position Title: Clinical Research Associate
Reporting to: Lead Site Liaison Manager
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.
Manage expectations for LOC, HCRISA Leadership, and CRSs related to study implementation, including the start-up timeline, enrolment, and site performance.
Prepares and presents study material at meetings and communicates outcomes to project team.
Other duties and assignments as requested for the overall performance of the department and company.
Works with HCRISA functional groups including Clinical Trials Managers, Regulatory Affairs Associates, Training Unit Associates, Laboratory Operations team members and Community Liaison team members to provide CRS support with protocol implementation.
Responsible for ensuring that monitoring onsite and remotely is done in a timely manner.
Serve as a contact for site knowledge and site-related queries
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.
Drawing on knowledge and relationships with sites’ operations, provide input to clinical research teams on site expertise and potential obstacles and challenges.
Provides appropriate project tracking using computer assisted programs and ensures up-to-date tracking and resolution of any project issues as required.
Reviewing monitoring 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 to verify the rights and well-being of human subjects are protected; to ensure the integrity of clinical data and the compliance of the investigator / site.
Assists with Audit/Inspection preparation.
Manages study site activities and provides ongoing site status updates to manager.
Anticipates/identifies potential problems and implements corrective actions.
Assists with the organisation of, and attends, study specific training.
Completes submission of documents to the Regulatory Authority and/or Ethics Committees when required.
Initiates innovative patient enrolment strategies with the project team and investigator sites.
Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.
Provide training to 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.
Reported (Serious) Adverse Events; submitted progress reports and general correspondence to ethics committees and the regulatory authority.
Ensured sites met recruitment targets, maintain in-house and site study files.
Write and submitted high quality monitoring reports within the required timelines.
Other duties, as required.
EDUCATION, CERTIFICATION, QUALIFICATIONS AND EXPERIENCE NEEDED
Minimum of 3 years onsite monitoring experience
Degree or equivalent qualification in public health, life sciences or medical field
Clinical trial monitoring and audit/inspection readiness experience, Clinical Research Associate II /Senior Clinical Research Associate experience in a trial set in Southern Africa and Africa.
An equivalent combination of education and experience may be accepted.
A thorough understanding of site monitoring and been involved during these in the past.
Understanding of clinical trial conduct in limited resource settings, and of regulations as they relate to clinical trials.
COMPETENCIES /SKILLS/ KNOWLEDGE
Clinical Research Expertise
Communication and interpersonal skills
Flexibility – able to travel internationally and within South Africa, and able to work after traditional business hours for communication with coordinating centre and sponsors in the USA
Effective communication and interpersonal skills; works well in a team environment
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.