What are the responsibilities and job description for the Clinical Research Manager - Florida and Vicinity position at GT Medical Technologies, Inc.?
Job Description
Job Description
Description : GammaTile®
The journey for a patient with a brain tumor is deeply emotional. Newly diagnosed patients often arrive at the emergency department due to changes in vision, balance, or cognitive function. Their world is quickly turned upside down as they race towards surgery. Unfortunately, many patients (~50% for glioblastomas) experience recurrence within a few months and, along with their dedicated family members and clinicians, must navigate treatment options once again. It has been over a decade since an innovative treatment option was cleared by the FDA—until GammaTile® Therapy!
GT Medical™ Technologies exists to provide a better option for these patients, caregivers, and clinicians. Guided by our Shared Values of Empathy, Empowerment, and Excellence, we strive to make a meaningful difference. Our Corporate Purpose is to Improve the Lives of Patients with Brain Tumors, and this mission drives us daily.
GammaTile® Therapy is supported by over 100 incredible teammates who collaborate organically, challenge appropriately, and are consumed with helping the next patient. With a goal growth rate of over 30% per year in orders, revenue, and clinical trial enrollments, our progress is encouraging, and we are aiming for even better results this year. We have a great core team, an innovative solution, and the resources to support further growth.
We are now seeking a Clinical Research Manager to add to our growing Clinical Affairs team. This individual will ideally be in the Florida area and available to work remotely as well as travel to our clinical sites as needed. If you have a heart for patients with brain tumors, the passion for clinical research, and a strong balance of strategy and tactical execution, we’d love to talk to you!
Position Summary - Remotely located in Florida or the vicinity
The Clinical Research Manager is responsible for initiating and managing clinical research sites. This position assists with site selection, site qualifications, and selection requirements, The Clinical Research Manager is responsible for site communication, documentation, data monitoring and reporting, study files, and IRB submissions for clinical trials. This position oversees adherence to SOPs, Good Clinical Practice, and FDA regulations. Ensures that project / department milestones / goals are met and adheres to approved budgets.
Job Duties / Responsibilities
- Support site start-up activities.
- Hold calls with sites to understand start-up process at institutions.
- Assist with site qualification and selection requirements.
- Work with sites to provide start up documentation for clinical team review and approval.
- Develop data forms for data capture.
- Build and / or validate electronic data capture system.
- Monitor data and produce site monitoring reports.
- Monitor DICOM image capture database.
- Keep study files organized and up to date (version control, completeness)
- Assist with central IRB submissions and tracking.
- Embodies the Company’s purpose and shared values, building a positive and productive team culture.
- Complies with Company policies and procedures.
- Authorized to access employee and / or patient PHI and ePHI only as needed for job-related functions.
- Other duties as assigned.
Requirements :
Physical Demands / Working Conditions
