Clinical Operations Specialist

This is a fully remote position, open to applicants in South Korea.

📋 Description

• Execute tasks in adherence to relevant Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions.

• Support Clinical Monitoring personnel with site management duties, acting as a Sponsor representative for assigned study sites.

• Engage with sites to guarantee compliance with protocol stipulations, study methodologies, and pertinent guidelines.

• Develop and assist in the upkeep of the Trial Master File (TMF) and project documentation, including involvement in file audits.

• Prepare and sustain site manuals, reference materials, and additional documents.

• Maintain, update, and enter clinical tracking data into databases.

• Monitor incoming and outgoing clinical and regulatory documents along with updates for investigator sites, studies, project teams, or clients.

• Oversee shared mailbox, manage site requests, and appropriately direct correspondence.

• Coordinate the ordering, packaging, shipping, and tracking of site supplies and materials.

• Assist in organizing team meetings, attend these meetings, and accurately prepare minutes and action items.

• Manage the receipt, tracking, and disposition of Case Report Forms and Queries as needed.

⛳️ Requirements

• High School diploma or equivalent qualification.

• Strong communication and interpersonal abilities.

• Willingness to adopt new technologies.

• Occasional travel of up to 25% may be necessary.

• Maintain an overall awareness of the clinical research field by completing all required and assigned training.

• Comparable experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations provided, when appropriate, for employees or applicants with disabilities.