IHCRA

What you will be doing:

Responsible for supporting in-house CRA activities relating to the running of Clinical Trials as defined by the study budget
* Providing support to the CRAs and directly to Sites to process and resolve queries and requests as required.

Job Description:

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 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. enrollment 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.

What you will need:

Bachelor's Level Degree

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.