Senior Clinical Research Associate, Cape Town based

IQVIA; Cape Town; On-site; ZAR 450,000 - 600,000; Full time

Job summary

A leading global clinical research company is seeking a Senior Clinical Research Associate in Cape Town. The role involves monitoring clinical sites, ensuring adherence to regulatory requirements, and managing study documentation. Ideal candidates should have at least 3 years of on-site monitoring experience and a relevant Bachelor's degree. Strong communication and organizational skills are essential, along with proficiency in Microsoft Office applications.

Qualifications

• At least 3 years of on-site monitoring experience.
• In-depth knowledge of GCP and ICH guidelines.
• Proficiency in Microsoft software.

Responsibilities

• Conduct monitoring visits and manage site expectations.
• Evaluate quality of study practices and escalate issues.
• Track study progress and maintain documentation.

Skills

On-site monitoring experience

Communication skills

Organizational skills

Problem-solving skills

Education

Bachelor's Degree in scientific discipline or healthcare

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job title : Senior Clinical Research Associate, Cape Town based

Job Location : Western Cape, Cape Town Deadline : September 01, 2025 Quick Recommended Links

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Job Description

Job Overview

Perform monitoring and site management work for a variety of protocols, site and therapeutic areas.

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 / ICH 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.

Act as a mentor for clinical staff including conducting co-monitoring and training visits.

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

Bachelor's Degree in scientific discipline or health care preferred. Req

Requires at least 3 years of year of on-site monitoring experience.

Equivalent combination of education, training and experience may be accepted in lieu of degree.

In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Strong therapeutic and protocol knowledge as provided in company training.

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.

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