Recognize, exemplify and adhere to ICON's values which centre 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 process to add value to our business and meeting client needs.
* *Become familiar with ICON's SOPs/WPs, ICH GCP guidelines and appropriate regulations.
* *Become familiar with ICON systems
* *Maintain timelines and ensure accuracy and completeness of data entered into ICON systems
* Become familiar with the principles of and assist with investigator recruitment
* *Serve as the primary in-house contact for sites and investigators participating in studies
* *Conducts and completes remote site management activities, with support as needed, according to applicable SOPS and the Study Monitoring Plan.
* *To contact Clinical sites for specific requests (e.g. enrolment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks.
* *Takes responsibility for project tasks and sees these tasks through to successful completion, with support.
* *Maintains a professional interpersonal relationship with study team, sites, and Sponsor.
* *Participates in QA Audits as needed.
* *Regularly attends and contributes to project specific and departmental meetings
* *Ability and willingness to travel as needed (drive and fly)
*Maintains Sponsor and patient confidentiality
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the *knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions if feasible for the role.
*Ability to liaise successfully and interact positively with clinical project teams, customers, site staff and all levels of staff across relevant departments.
*Effective prioritization skills, ability to multi-task and meticulous attention to detail.
*Comprehensive knowledge and understanding of ICH-GCP and other relevant regulations for the conduct of clinical trials related to pharmaceuticals, biologics, medical devices and combination products.
*Competent computer skills
*Good oral and written communication skills
*Due to the nature of this position, it may be required for the employee to travel. Therefore dependent on the employee's location, a valid driver's license will be required
*Foreign language skills desirable
* Other duties as assigned