Study Support Assistant (site dedicated) - Waterloo

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Your responsibilities include:

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Provide general administrative support to the team.
• Support the Study Start Up Leads including tracking, filing and other coordinating tasks.
• Assist the team with submission documentation and guidelines, as appropriate.
• Collate and verify, for completeness, submission documentation for submission to the Regulatory/Competent Authority (CA)/Ethics Committee (EC) and other relevant authorities.
• Co-ordinate, dispatch and track submissions to CNEC and other relevant authorities.
• Assist in the translation of documents required for submission to CNEC and other relevant authorities.
• Co-ordinate the translation of documents required for submission to CNEC and other relevant authorities.
• Assist team with submission progress tracking by updating the relevant ICON/Sponsor tracking system, as required.
• Copy and route incoming correspondence, internal documentation etc, as appropriate.
• Be familiar with ICH GCP and relevant ICON SOPs.
• Be competent with ICON/sponsor Clinical Trial Management System (CTMS), as appropriate.
• Set up, organize and maintain department electronic filing systems.
• Assist in co-ordination of payments to CA/EC and other relevant authorities, as appropriate.
• Set up and organize meetings, as requested.
• Attend team meetings and generate meeting minutes.

Your qualifications

• University degree in Health Science, or a related field (an equivalent combination of education, training, and work experience may be considered)
• Two years experience in Clinical Research or related industry
• Oncology experience required
• Understanding of Good Clinical Practices/International Committee on Harmonization principles
• Strong social and interpersonal skills (written and oral). You will be confident speaking to Health Care Professionals.
• You are able to influence without authority
• You work effectively both independently and in a team environment
• You are self-motivated and able to display autonomy and initiative
• You apply a strong attention to detail
• You seek multiple demands/projects simultaneously
• Effective time management skills
• Your passion lies in customer service
• You have good knowledge of MS Office (Word, Excel, PowerPoint) d using multiple computer systems

Compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level

Benefits of Working in ICON:revious administrative experience preferably in the medical/ life science field

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.