RA Associate I

Study Start Up Associate I (RA Associate)

Seoul, Korea

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a SSU you will be responsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards Also responsible for the independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory/sponsor requirements – within specific timelines and quality standards.  Developing and finalizing Master and Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs)

Responsibilities;

- Responsible for logistic managements including the preparation of submission packages for import permit applications and custom clearance

- Responsible for regulatory maintenance activities including IND amend & notification and annual report of ongoing studies in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards; accountable for the dispatch and tracking of submissions to Regulatory Authority(RA)and communication with MFDS.

- Responsible for co-ordination of translations and filing of country level related documents

- Develop and finalize Country Specific Information Sheets / Informed Consent Forms (SIS/ICFs). Deliver the sponsor specific training for assigned country level personnel.

- Communication with study team and sponsor(if needed)

- Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country information in the appropriate clinical trial management system

Requirements;

- Bachelor’s Degree or higher graduate degree from the Medical/science background and/or discipline

- At least 1year of working experience in multinational pharmaceutical companies or CROs

- Experience of logistic activities including import permit applications (Preferred)

- Experience of MFDS submissions or notifications (Preferred)

- Knowledge of local regulatory requirements/guidelines and global standards (Preferred)

- Experience reviewing Informed Consent Forms and following up with Legal as needed in accordance with the protocol (Preferred)

- Effective oral and written communication skills

- Excellent written and spoken English

- Competent computer skills

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes.  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.   

What’s Next

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer -  M/F/D/V and committed to providing a workplace free of any discrimination or harassment.