Senior Clinical Research Associate

2 weeks ago

Centurion, South Africa Novasyte Full time

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.

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.
- 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 site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

**Qualifications**:

- Degree in scientific discipline or health care preferred.
- Requires at least 3+ years of of on-site independent monitoring experience..
- 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.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

  • Senior Clinical Research Associate

    2 weeks ago

    Centurion, Gauteng, South Africa Novasyte Full time

    Job OverviewPerform 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.Essential Functions Perform site monitoring visits (selection, initiation, monitoring and closeout visits) in accordance with...

  • Senior Clinical Research Associate Fsp

    2 weeks ago

    Centurion, South Africa Novasyte Full time

    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...

  • Senior Clinical Research Associate Fsp

    2 months ago

    Centurion, South Africa Novasyte Full time

    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...

  • Senior Clinical Research Associate

    2 weeks ago

    Centurion, South Africa Novasyte Full time

    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...

  • Senior Clinical Research Associate

    7 days ago

    Centurion, South Africa Novasyte Full time

    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. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Clinical Data Manager

    2 weeks ago

    Centurion, Gauteng, South Africa DFNet Research Full time

    Clinical Data ManagerSouth Africa | Remote DFnet provides data management, biostatistics, and software development services for industry, nonprofit, and academic organizations worldwide. Since 2004, DFnet's people, products, and services have helped our global clients with over 100 Phase I through Phase IV clinical trials. Our focus is global health. DFnet...

  • Senior Clinical Research Associate Ii

    3 weeks ago

    Centurion, South Africa Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Data Manager

    4 weeks ago

    Centurion, South Africa DFNet Research Full time

    **Clinical Data Manager** **South Africa | Remote** - DFnet provides data management, biostatistics, and software development services for industry, non-profit, and academic organizations worldwide. Since 2004, DFnet’s people, products, and services have helped our global clients with over 100 Phase I through Phase IV clinical trials. Our focus is global...

  • Clinical Governance Researcher

    2 weeks ago

    Centurion, South Africa Health Solutions Full time

    **Introduction** Momentum Health Solutions, an entity of Momentum Metropolitan Holdings delivers sustainable, integrated health solutions that meet the needs of clients in the different segments and maximise lifetime client value. We build and maintain a culture of innovation, and create value through unique insights of how to achieve specific outcomes by...

  • Clinical Research Associate

    2 weeks ago

    Centurion, South Africa Novasyte Full time

    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. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Clinical Research Associate

    7 days ago

    Centurion, South Africa Novasyte Full time

    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. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Clinical Trials Assistant

    2 months ago

    Centurion, South Africa IQVIA Full time

    **Job Overview** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. **Essential Functions** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...

  • Clinical Governance Researcher

    2 weeks ago

    Centurion, Gauteng, South Africa Health Solutions Full time

    IntroductionMomentum Health Solutions, an entity of Momentum Metropolitan Holdings delivers sustainable, integrated health solutions that meet the needs of clients in the different segments and maximise lifetime client value. We build and maintain a culture of innovation, and create value through unique insights of how to achieve specific outcomes by using a...

  • Clinical Research Associate

    3 weeks ago

    Centurion, South Africa IQVIA Full time

    **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. **Essential Functions** - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...

  • Clinical Trial Assistant

    3 weeks ago

    Centurion, South Africa IQVIA Full time

    **Essential Functions** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution,...

  • Associate Director, Regulatory Affairs

    2 weeks ago

    Centurion, South Africa FHI Clinical Inc Full time

    **Essential Functions**: - Expected to be the accountable point of contact for designated clients, responsible not only for RA deliverables but also for proactive communication and budget adherence. - Act as the Lead Regulatory Professional for regulatory projects awarded to FHIC, with support from other senior colleagues. - Provides Clinical Research...

  • Snr Clinical Trial Assistant

    3 weeks ago

    Centurion, South Africa Novasyte Full time

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

  • Medical Writing Manager

    3 weeks ago

    Centurion, South Africa FHI Clinical Inc Full time

    **Summary of The Position**: The Medical Writing Manager is tasked with the writing of trial-related documentation for clinical projects undertaken by the Company in accordance with ICH GCP and local legal requirements, European, FDA and other international guidelines, as well as Company (and sponsor, if applicable) Procedural Documents. The Medical Writing...

  • Senior Manager Clinical Consulting Services

    3 days ago

    Centurion, South Africa Affirmative Portfolios Full time

    **Medical / Emergency / Health / Lab** **Centurion - Gauteng** ***: **Senior Manager Clinical Consulting Services - Centurion** **Salary: R1,457,357.00pa CTC** **Overview**: The purpose of the job is to oversee the provision of Clinical services, administer the Prescribed Minimum Benefits (PMB) portfolio to ensure medical scheme members are protected and...

  • Medical Writing Manager

    2 weeks ago

    Centurion, Gauteng, South Africa FHI Clinical Inc Full time

    Summary of The Position:The Medical Writing Manager is tasked with the writing of trial-related documentation for clinical projects undertaken by the Company in accordance with ICH GCP and local legal requirements, European, FDA and other international guidelines, as well as Company (and sponsor, if applicable) Procedural Documents. The Medical Writing...