Senior Clinical Research Associate Fsp - Centurion, South Africa - Novasyte

Novasyte

Verified Company

Centurion, South Africa

1 day ago

Posted by:

Thabo Mthembu

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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 closeout 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 startup 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 followup letters and other required study documentation.
Act as a mentor for clinical staff including conducting comonitoring 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:

High School Diploma or equivalent Degree in scientific discipline or health care preferred.
Requires at least 3 years of year of onsite 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 problemsolving 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