IHCRA
About the role
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IHCRA
Responsibilities:
* 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
Benefits of Working in ICON :
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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