Clinical Research Associate, Sponsor Dedicated, Gauteng

IQVIA; Centurion; On-site; ZAR 500 000 - 700 000; Full time

Job summary

A global clinical research organization seeks a Site Monitor to ensure adherence to study protocols in oncology clinical trials. Candidates must hold a Bachelor’s degree in a scientific discipline and have at least 2-3 years of on-site monitoring experience. Key responsibilities include conducting monitoring visits, managing regulatory submissions, and ensuring quality site practices. Strong communication and organizational skills are essential, as well as proficiency in Microsoft Office tools. This role contributes to improving patient outcomes and population health globally.

Qualifications

• At least 2-3 years of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements.
• Experience in Inflammatory Bowel Disease (IBD) is an advantage.

Responsibilities

• Perform site monitoring visits including selection, initiation, and close-out.
• Work with sites to track subject recruitment plan.
• Administer protocol training to assigned sites.

Skills

Oncology experience

Communication skills

Organizational skills

Problem-solving skills

Time management

Computer proficiency

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

Job description

Job Family Description

Monitors assigned sites to ensure that clinical research studies adhere to standard protocols and SOPs.

Sub-Family Description

• Monitors during clinical research studies to ensure trials are being conducted in accordance with widely accepted clinical practices.
• Conducts on-site and remote monitoring using a combination of corporate and customer systems and tools to ensure quality monitoring
• Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
• Site field and remote monitoring visits for dedicated assigned sponsor(s) through direct customer interaction

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. The therapeutic area covered is Oncology.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications, Knowledge and Skills

• Bachelor's Degree Degree in scientific discipline or health care preferred.
• Requires at least 2 - 3 years of on-site monitoring experience.
• Oncology experience essential.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Experience in Inflammatory Bowel Disease (IDB) is an advantage
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com