Regulatory Data Coordinator

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
 

Job Overview:

This position is responsible for the completion of all initial IRB submissions and maintenance of regulatory documents for all clinical trials. The Regulatory Data Coordinator will work closely with Medical Director, Project Manager, Clinical Research Coordinators and Manager, Clinical Data Services to ensure the timely and accurate submission of regulatory documents to the IRB.

Responsibilities:

• Management of activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/ countries.
• Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the LRAA is responsible for.
• Ensuring that IP labels are in adherence to country requirements and submitted where applicable. 
• Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate.
• Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems. 
• Perform role of Local Reviewer in the QC process as appropriate.
• Providing consultancy to the client on any country specific issues if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM). 
• Less than 10% travel involved

Skills:

• Applies knowledge of PRA policies, procedures and office environment
• Applies knowledge of computerized information systems and standard application software (Windows, MS Office)
• Demonstrates limited knowledge of clinical research and/or regulatory affairs industry practices and standards
• Exhibits good communication and interpersonal skills
• Demonstrates an ability to understand country specific requirements and ho they need to be applied to a clinical trial or product registration

Qualifications:

• Undergraduate degree or its international equivalent in clinical, science, or health- related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required
• Knowledge of current ICH and local Regulatory Agency and/or Ethics Committee regulations as they relate to pharmaceutical,
  biological, biosimilar, and medical device product development.
• Some experience preparing RA and/or Central IEC submissions for Clinical Trial Applications preferred.
• Knowledge or awareness of current regional guidelines and
  regulations is preferred,
  as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
• Prior experience using computerized information systems required; experience with PC Windows, word processing, and electronic spreadsheets required.
• Read, write, and speak fluent English; fluent in host country language
   

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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