Clinical Research Manager

4 weeks ago

Tempe, United States GT Medical Technologies, Inc. Full time
Job DescriptionJob DescriptionDescription:

Status: Full Time, Salary

Location: East Coast or Mid-West Remote

Travel: Up to 25%


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 Mid-West or East Coast 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

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

  • Supports site start-up activities.
  • Holds calls with sites to understand start-up process at institutions.
  • Assists with site qualification and selection requirements.
  • Works with sites to provide start up documentation for clinical team review and approval.
  • Develops data forms for data capture.
  • Builds and/or validates electronic data capture system.
  • Monitors data and produces site monitoring reports.
  • Monitors DICOM image capture database.
  • Keeps study files organized and up to date (version control, completeness)
  • Assists 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.
  • Completes other duties as assigned.


Requirements:

Qualifications

  • Bachelor’s degree, preferably in the life sciences.
  • 5 years of related experience.
  • Medical writing experience.
  • Prefer clinical research associate (CRA) experience and/or certification.
  • GCP training and certification.
  • Knowledge of computer systems and business applications.
  • Excellent communication skills.
  • Proficient in using Microsoft office programs (Word, Excel and PowerPoint).
  • Willingness to work a flexible schedule.
  • Able to travel for site initiations and monitoring and other work as needed.
  • Satisfactorily pass a drug screen if needed for facility credentialing.
  • Satisfactorily pass comprehensive background screening.

Physical Demands/Working Conditions

  • Typical work environment for a professional office or home office space.
  • Occasionally works in a clinical or hospital setting.
  • Largely a stationary role with some moving from place to place.
  • Constant use of a computer, keyboard, mouse, monitor and other office equipment.
  • Occasionally picks up, carries, and moves items up to 30 lbs.
  • Some evening and weekend work depending upon workload.
  • Some overnight travel may be required for work, events, and training.

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