Study Start Up Associate I

This is an exciting opportunity to join ICON

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. Developing and finalizing Master and Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs)

Currently we are hiring the Study Start Up Associate I/II role to be based in Seoul, Korea.

Role Summary;

Serving as a primary contact for investigators and research coordinators, you will perform feasibility, site identification, site contract negotiation and other assigned study startup activities. This will include the preparation, review and approval of country related ethics/regulatory submission packages and site level critical documents for Investigational Product (IP) release. Some travel is anticipated, to attend Kick-Off, Investigator and/or study team meetings.

Key responsibilities:

- Prepare, review contract negotiation with external sites, working to project deadline to finalise study contracts

- You will be collaborating with multiple internal and external teams to coordinate the contract templates and budgets throughout the timeframe

- Completing contract amendment activities

- Other study start up activities as required including: ethics submissions, creating submissions packages, amendments to study documentation according to country guidelines in Chin

To succeed you will need:

- Bachelor's Degree preferably in life sciences will ensure your familiarity with regulatory guidelines and industry knowledge.

- Minimum of 1 year of experience or understanding of clinical study start up requirements and activities; IRB submission & Approval, Budget and Contract nego with sites, etc.

- Fluent in local language and English, you will possess excellent written and verbal communication and interpersonal skills enabling you to deal with queries in a timely manner.

- You should be able to produce accurate work to tight deadlines within a pressurised environment

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, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.