Clinical Research Associate

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GT Medical Technologies, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2017

🏭 Manufacturing

🏥 Healthcare

🔬 Science

Manufacturing • Healthcare • Science

GT Medical Technologies, Inc. is a medical technology company that develops and commercializes GammaTile Therapy, a surgically targeted radiation therapy (STaRT) for operable brain tumors. Its GammaTile product is an implantable radiotherapy device indicated for newly diagnosed and recurrent intracranial neoplasms, designed to deliver localized radiation to the tumor bed at the time of surgery. The company supports healthcare providers and patients with clinical resources, treatment centers, ordering, and educational materials to improve outcomes for patients with brain tumors.

📋 Description

• Conduct site monitoring visits, including feasibility, initiation, routine monitoring, and close-out visits • Deliver protocol-specific and study-related training to assigned sites • Maintain communication with sites regarding study expectations, questions, and emerging issues • Perform source data review and verification • Assess site compliance with protocols, GCP, and applicable regulations • Monitor enrollment, CRF completion, EDC entry, and query resolution • Escalate compliance issues, protocol deviations, and data quality concerns • Verify collection and filing of essential regulatory documents in the TMF • Confirm maintenance of Investigator Site Files in accordance with GCP and local regulations • Document monitoring activities through visit reports, follow-up correspondence, and action plans • Collaborate with cross-functional study team members on study execution and issue resolution • Contribute to site-level recruitment plans • Conduct site close-out visits and resolve outstanding queries and regulatory reconciliation • Support site start-up activities • Support regulatory document tracking and filing • Comply with company policies and procedures and protect PHI/ePHI • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree in a scientific or health-related discipline preferred • 1–2 years of related experience in clinical research • Experience as a Clinical Research Coordinator (CRC) or Sponsor CRA preferred • Experience with clinical site data collection and/or monitoring preferred • Oncology clinical research experience strongly preferred • GCP training and certification • Working knowledge of computer systems and standard business applications • Strong verbal and written communication skills • Excellent organizational skills and attention to detail and accuracy • Ability to work independently and collaborate effectively with cross-functional teams • Proficiency in Microsoft Office applications, including SharePoint, Word, Excel, and PowerPoint • Flexibility to work varied schedules • Must satisfactorily pass comprehensive background screening • Ability to travel frequently, including occasional to frequent overnight travel • 60–70% travel required • Ability to frequently pick up, carry, and move items up to 50 lbs. • Some evening and weekend work depending on workload

🏖️ Benefits

• Exempt status • Remote work arrangement • GCP training and certification • Work environments include office, home, hotel, events, and hospital • Company-paid travel for work, meetings, events, and trainings