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
- 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 procedures
COMMUNICATION
- 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 appropriate
BUSINESS 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 presentations
TEAMWORK
- 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 Sponsor
PERSONAL/PROFESSIONAL DEVELOPMENT
- Continues to increase knowledge of therapeutic areas, GCP and any applicable local regulatory requirements
**IPD/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 au