Site Activation Partner - FSP (Contractor)

Overview

Support clinical trial site activation and study conduct activities, coordinating regulatory documents, ethics submissions, site communications, and trial system updates.

What you'll do

• Coordinate site start-up activities and essential document management through site initiation approval.
• Prepare, validate, and submit regulatory and ethics documentation.
• Coordinate investigator site, client, study team, and committee communications.
• Maintain trial documents, IRB or ethics activities, and Trial Master File records.
• Update clinical trial systems tracking site compliance and performance.
• Support site audits, awareness sessions, and corrective and preventive actions.
• Mentor new hires and contribute as a subject matter expert when assigned.

What you'll need

• At least 2 years of relevant clinical site management experience.
• Knowledge of clinical research, clinical trial operations, and site activation processes.
• Knowledge of ICH-GCP, FDA, global, and local country regulations.
• Fluency in the local language and English.
• Ability to use Microsoft Suite, CTMS, electronic trial files, and document portals.
• School diploma or certificate with equivalent education, training, and experience, or a bachelor's degree.
• Ability to organize priorities, work independently and collaboratively, and maintain attention to detail.

Nice to have

• Experience in the pharmaceutical industry or a CRO.
• Education in a life sciences discipline.
• Multilanguage capability.
• Good knowledge of clinical trial methodologies.

Details

• Remote in South Korea, with 2–3 days per week at the client's office.
• Fixed-term contract through April 2027.
• Travel may be required, including some international travel.