Study Support Assistant

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.

What you will be doing:

• Recognize, exemplify and adhere to ICON's values, which center on 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.• Positive attitude towards their position and ICON• Ability to work on study teams that are often virtual, multi-cultural, and multi-disciplinary• Serves as the primary contact for sites and investigators participating in studies• Acts as a resource for internal study teams and other ICON departments• Maintains, reviews, and ensures adequacy of information and data contained in site management reports, tracking systems (CTMS or others) and other site management documents• Conducts and completes remote site management activities, with support as needed, according to applicable SOPs and the Site Management Plan• Supports the Research Services Department by applying critical thinking about the business needs of a study and/or Site Management activities• Participates in QA audits as needed• Regularly attends and contributes to project specific and departmental meetings• Assists, as needed, in developing and reviewing study documents• Ability and willingness to travel as needed (drive and fly) - approximately 25% of the time• Reviews drug storage and drug accountability procedures (as applicable), in accordance with applicable SOPs• Maintains and archives study documentation and correspondence, as needed• Assists with site contracting process, as needed• Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed• Assists with SAS/Steering Committee organization and attendance when applicable• Demonstrates increasing ability to manage site assignments and workload• Maintains Sponsor and patient confidentiality• Actively participates in regular meetings with Project Managers or delegate, and/or RS Lead to discuss project strengths and challenges associated with recruitment, enrolment, site communications and site responsiveness• Assumes additional responsibilities as detailed and documented by PM or delegate, RS Lead or Line Management• Assists in development of site and patient enrolment strategies with project team; works to motivate sites to meet enrolment timelines• Demonstrates ability to implement the study monitoring plans/metrics as appropriate and agreed upon• Working knowledge of and compliance with local regulatory requirements• Compliant and current with departmental and corporate policies and proceduresCOMMUNICATION• Excellent written and oral skills while showing cultural awareness and understanding; strong presentation skills, proactive interaction with study team and site staff• Demonstrates ability to provide and receive constructive feedback; appreciates team goals, respects others point of view and seeks advice when appropriateBUSINESS DEVELOPMENT• Supports and fosters relationships with internal and external customers• May support the development of proposals for new business and attend bid defence presentations• May attend bid defence presentations, as needed• Supports internal and external capabilities presentationsTEAMWORK• Participates in training and mentoring of junior staff• Works in collaboration with internal and external colleagues to meet project objectives, timelines, and budget• Supports and follows departmental policies and procedures• Takes responsibility for project tasks and sees these tasks through to successful completion• Completes special projects and miscellaneous assignments as needed to meet project and/or department objectives• Maintains professional interpersonal relationships with team, sites, and SponsorPERSONAL/PROFESSIONAL DEVELOPMENT• Continues to increase knowledge of therapeutic areas, GCP and any applicable local regulatory requirementsIPD/ICON based SSA:• 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.• Assist in the production of slides, overheads, etc., as needed for team meetings, departmental, sponsor and/or business development presentations.• Willingness to travel for job related activities if required (expected travel for this position is • Assist in other related tasks under the direction of the Study Start Up Manager, as required.

ISS SSA when working at study sites:

Under the oversight of the principal investigator at each site as required  by GCP (Good Clinical Practice): performs administrative tasks for the proper support of clinical research studies. • Administrative support  for the Principal Investigator/Site team in transcription of  source document data points into EDC/CRF, including support for answering queries, in the expected timelines, subject to final sign off of the Principal Investigator on transcription, and which can be clearly accessed in source documents. • On-site and off-site monitoring visit support, such as communication with CRAs for scheduling visits, providing access to site documentation and supplies to CRA reviews, accommodate meetings with site staff, etc.  

 For the  avoidance  of doubt  the  responsibilities described  above  do not  include  study activities to be performed by the  principal investigator, sub-investigator or clinical  nurses such as medical evaluations, maintaining medical charts, investigative medicinal product dispensing/administration, AE/SAE evaluation,  preparation of medication, or any other  task relating to the medical care of trial subjects. The Principal Investigator at each site remains responsible for the supervision and delegation  of the administrative tasks to ICON personnel at each site in accordance  with GCP and which are typically documented in the delegation  log.

• Travel (approximately up to 66%) domestic and/or international, as required.

What do you need to have?

• The successful candidate will have a high school diploma, or local equivalent with good interpersonal skills and the ability to handle multiple tasks with meticulous attention to detail• Research or Healthcare related academic or work experience would be preferable but not essential• You will possess excellent written and verbal communication in English

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, 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, colour, 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 or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.