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HCRISA VACANCY: Senior Site Liaison Associate (equivalent to Senior CRA)

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


Closing date for applications 30 June 2022.