Regulatory Documents Coordinator I

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Are you looking for a rewarding position that can change peoples lives for the better? If so, this extraordinary opportunity is not to be missed.

ICON is recruiting for a Regulatory Documents Coordinator. The position is responsible for preparing and submitting regulatory documents to the sponsor and institutional review board in an accurate and timely manner. In addition the Regulatory Documents Coordinator will provide administrative and clerical support to the management team and other staff members.

Responsibilities:

• Prepares and submits new trial regulatory packets according to instructions from the Sponsor/CRO

• Communicates in a timely manner with Sponsor/CRO and IRB regarding regulatory submission questions.

• Facilitates PI and Manager of Clinical Operations signatures for the Clinical Trial Agreement (CTA)

• Submits any amendments/revisions to the protocol or changes to the consent form and updated advertisements to the IRB as needed.

• Verifies and edits if needed the final approved Informed Consent Form using the Accellacare Informed Consent Form Checklist. Provides final approved Informed Consent Form with Accellacare Informed Consent Checklist to the appropriate study coordinator.

• Updates CV's annually for all staff and investigators; obtains updated medical licenses and certificates of insurance for all investigators and licensed Accellacare staff. Posts all documents including GCP certificates to Accellacare SharePoint

• Provides support for patient recruitment calls per site needs.

• Assists with training new staff members on regulatory process.

Education/Experience:

• Bachelor's Degree in Life Sciences
• Fluency in English (written/oral)
• Basic clinical research knowledge

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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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