Data Compliance and Quality Coordinator (Western Cape)-151978

Europe, Middle East & Africa-South Africa
On Application
22 Nov 2018
18 Jan 2019
Synexus, a partner of PPD, is the world’s largest site network, with more than 195 sites and 1,500 employees. We provide customers with access to more than 100 million patients in key clinical development markets including Europe, South Africa and the United States.
“Our Dedicated Research Sites are where high quality staff engagement and top of the class facilities meet with the client expectation for fast enrollment and delivery."
-Dr Radoslaw Janiak (President & COO, Synexus)
Our success is based on a simple, but crucial, principle. We place the patient at the heart of everything we do. Synexus is a world class Site Network Organisation with global expertise spanning patient recruitment, trial planning, management and patient retention.
We recruit and retain more engaged patients, at fewer sites, and in less time than traditional centers, enhancing the quality and efficiency of our customers’ drug development programs.

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!
Our site, Helderberg Clinical Research Centre located in Sommerset West, Western Cape is currently looking to recruit a Data Compliance and Quality Coordinator to complement the existing clinical team.
The key purpose of the Data Compliance and Quality Coordinator (DC & QC) is to provide quality control to the Clinical Trial Process by ensuring all study documentation and source data is accurately captured in CRF and up to date; maintaining the Investigator Site Files (ISF) as well as to perform quality checks and answering any CRF queries in a timely manner.
Key roles and responsibilities for a DC & QC are:
  • Be a dedicated DC & QC on one or more studies to ensure the successful delivery of projects
  • Ensure that all data has been accurately entered in the CRF from the source notes
  • Responsible for the maintenance of ISF as delegated
  • Follow the QC process and check that ICF’s are correctly completed
  • Check patient visits are within visit windows, as per protocol, and report deviations
  • Enter all data within the appropriate timelines as specified within the study protocols.
  • Ensure that protocol visit windows are scheduled according to the protocol requirements
  • Ability to track the flow of CRFs, queries and patient recruitment status and ability to report out the flow of data.
  • Maintain detailed study trackers if required
  • QC all supporting reports (laboratory reports/GP SDV/Consultant) to ensure it is reviewed and signed off by a physician within the appropriate timelines and flag any out of range values
  • Assist archiving procedures if required
  • Assist and liaise with monitors, sponsor representatives and assist with the preparation  of monitoring visits
  • Assist peers with daily duties and administration requirements on projects
  • Frequently liaise with monitors to clarify concerns relating to CRF completions and  resolve queries
  • Work with medics (PI/ RP) and other site staff to complete source data promptly and ensure  corrections are done in a timely manner
  • Ensure prompt response within agreed timeframes to data clarification request
  • Be polite and courteous to all external and internal contacts and participants
  • Attend Site Initiation Visits (SIV) and Pre-Selections Visits (PSV) and kick-off meetings when required
  • Able to identify a  Quality Issue (QI) and to report it to the relevant OCM/DQM/SD
  • Have basic knowledge to prepare and collate regulatory documents for submission
  • Ensure SOP & COP’s are adhered to
  • Basic knowledge to apply General Local Data Protection Regulation
  • Able to understand Company SOP and COP and to assist with input during the review process
  • Able to assist with the review of informed consent forms and to escalate concerns to the DQM
  • Competent to understand and apply rules and regulations of ICH GCP and other regulatory and ethical guidelines
  • Able to verify and check if staff study specific training is documented
  • Basic knowledge of CAPA reporting and root cause analyses
  • Assist during audit preparation and ensure audit readiness of site files
  • Assist with the drafting compliance reports and give input
  • Attend regular site meetings regarding site operations and quality and share feedback from monitor visits


Qualifications and Experience:
To be considered for this exciting opportunity you will require the following:
  • High/Secondary School diploma/ or equivalent and relevant formal academic / vocational qualification
  • 1 years’ working experience that provide the ability to perform the job
  • Experience to multi-task and ability to have oversight over a few studies with a number of participants simultaneously
  • Excellent Interpersonal skills
  • Good working knowledge of Business English
  • Appropriate MS Office Skills
  • Medical Terminology knowledge is an advantage
Interested? Great, please apply by the closing date of Friday, 30 November 2018.  

Synexus is an Affirmative Action and Equal Opportunity Employer#LI-MC2