IHCRA

In House Clinical Research Associate (IHCRA) | Taiwan

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?

To be a successful IHCRA, we will provide you adequate training and support enabling you to confidently perform the essential duties satisfactorily and your job responsibilities are not limited to the following:

• Become familiar with ICON's SOPs/WPs, ICH GCP guidelines, regulations and 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

• Conduct and complete 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

• General ad hoc duties and administration as requested

What you need

• 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

• Global or local CRO work experience advantageous