Senior Compliance Specialist (Affiliate Sites) at Synexus Clinical Research Ltd

Competitive + Benefits

Introduction

• Do you have an audit/quality compliance background?
• Do you want to work for a leading multinational organisation, renowned throughout the industry for its meteoric rise to success and dependability to deliver on global contracts across multiple therapeutic areas and phases?
• Are you looking to play an integral role in the future of medicine across the globe? If so, this may be the opportunity for you!

We are currently looking to recruit a Senior Compliance Specialist, predominately working from home, that will oversee 9 x affiliate sites across Gauteng and Free State and will include site visits as well as attending weekly meetings at the Head Office in Pretoria.

This role will be responsible for providing quality control to the clinical trial process by ensuring all study documentation and source data is accurate and up to date; maintaining the Investigator Site Files (ISF) as well as performing quality compliance checks and answering any CRF queries in a timely manner.

The Role

Key responsibilities for the Senior Compliance Specialist are as follows:

• Acts as a core operational compliance specialist on several studies to ensure the successful delivery of projects
• Participates in the start-up, set-up and close out of projects, ensuring adherence to the client and company expectations.
• Ensures accurate and timely entry of all data in the CRF from the source notes and track the flow of the CRF’s, queries and patient recruitment status and report out the flow of data.
• Maintains ISF and trackers as delegated.
• Ensures patient visits are within visit windows, as per protocol, and reports deviations.
• Assists with archiving procedures, if required.
• Serves as a liaison with monitors and client representatives, and completes preparations for monitoring visit duties and audits.
• Ensures prompt response within agreed timeframes to data clarification requests.
• Identifies quality issues (QI) and reports it as required, and supports, trains and mentors junior staff.
• Ensures SOP & COP’s are adhered to and gives clarity and guidance to others in the implementation thereof.
• Reviews informed consent forms for completion and escalates concerns to management.
• Ensures adherence to rules and regulations of ICH, GCP and other regulatory and ethical guidelines as well as data protection regulations.
• Reports any non-compliance of service level agreements.
• Highlights any auditor findings and proposes CAPA actions and root cause analyses.
• Responsible for audit preparation and ensuring the audit readiness of site files.
• Identifies trends in data queries.
• Provides guidance on functional GCP, and other compliance and quality related topics, as required, to improve quality and expertise within the site.
• Identifies quality compliance training needs of site staff and provides training, as required (i.e. data systems, ISF) and assists with induction of new site staff.

The Person

To be considered for this exciting opportunity you will require the following skills and experience:

• Professional knowledge of theory and techniques in the data and compliance field
• Comprehensive industry knowledge of quality compliance, GCP
• Strong understanding of the audit process, including audit preparation and oversight, sponsor, internal audits regulatory authority and FDA will be advantage), as well as CAPA reporting and basic root cause analyses
• Experience with the preparation of and collation of regulatory documents for ethics submissions
• Strong multitasking and project management skills
• Strong interpersonal, leadership, and consultative skills
• Good working knowledge of Business English
• Appropriate MS Office Skills
• Strong medical terminology knowledge
• Strong time management skills
• Thorough attention to detail
• Drivers license and own vehicle

Interested? Great, please apply ASAP as we may close the advert earlier than the expiry date.

Synexus is an Affirmative Action and Equal Opportunity Employer.