IHCRA

In House CRA

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

• 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

ICON Plc is an equal opportunity employer. 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.