Clin Ops Specialist, CTA

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Support Clinical Monitoring personnel with site management tasks and act as a Sponsor representative for designated study sites.

• Engage with sites to guarantee adherence to protocol requirements, study procedures, and applicable guidelines.

• Develop and maintain the Trial Master File (TMF) and project documentation, including participation in file audits.

• Prepare and update site manuals, reference materials, and other essential documents.

• Sustain, revise, and input clinical tracking data into databases.

• Monitor the influx and outflux of clinical and regulatory documents and updates for investigator sites, studies, project teams, or clients.

• Manage a shared mailbox, process site inquiries, and appropriately route communications.

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

• Assist in scheduling team meetings, attend said meetings, and compile accurate minutes and action items.

• Oversee the receipt, tracking, and disposition of Case Report Forms and Queries as necessary.

• Stay informed about clinical research through required and designated training.

⛳️ Requirements

• High School diploma or equivalent qualification.

• Strong communication and interpersonal abilities.

• Willingness to adopt new technologies.

• Occasional travel up to 25% may be necessary.

• Activities must align with relevant Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and comprehensive rewards program.

• Inclusive workplace culture.

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