Records Management Specialist 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.

You will have the opportunity to work on clinical studies at different stages of the project lifecycle and gain a variety of therapeutic experience. This role supports with feasibility, study start-up, assisting sites during maintenance and closing out sites.

Key responsibilities in this position include:

• Working within the framework of the study protocol, to assist with the preparation and organisation of investigator and study site materials both at a local and international level.
• Working closely with Clinical Team Managers, Start-Up Leads and Clinical Research Associates.
• Working with the wider PRA project team including Regulatory, Contracts and Project Management.
• Performing investigative site recruitment and evaluation.
• Essential document collection, review and maintenance.
• In-house site management activities and ensuring that all study files and documents are current and complete.

You will be responsible for supporting clinical trials including, but not limited to, clinical documentation, coordinating team meetings, taking meeting minutes, ordering supplies for study sites, and QC of data for clinical studies. You will create spreadsheets for reporting, generate reports and log documents. You will be supporting a variety of groups within the company so flexibility is key!

What do you need to have?

Level 1 Qualifications:

• The clinical development study and project coordination activities are accomplished through a strong skill set, understanding of clinical development and global operating processes of drug development as well as in-depth knowledge of ICH-GCP and international regulations.
• The incumbent must have a high school degree with 2+ years of relevant experience or 2-year college degree (or equivalent) with 0-2 years of relevant experience.

Additional Skills Needed:

• Manage multiple tasks in parallel

• Good computer skills

• Knowledge of all Microsoft Office Programs

• SharePoint knowledge helpful

• Excellent follow-up skills

• Effective planning and organization skills

• Good interpersonal skills

• Effective verbal and written communication skills

• Keen attention to detail

• Motivated/driven

• Willing to learn

• Data Entry experience

• TMF experience helpful

• Meeting coordination, calendar management, meeting logistics set up.

• Taking meeting minutes

• Spreadsheet maintenance

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.