This position will report to the Director of Clinical Affairs and work on clinical trials supporting the GID SVF platform. This individual will be responsible for all phases of clinical trials to include protocol development, case report forms, work instructions, site initiation, site training, site management, monitoring and site close out. This position will require 20-50% travel.
Participate in writing protocols, informed consents, IRB submissions, case report forms, and work instructions
Participate in FDA Submissions
Participate in all aspects of site start up activities.
Manage assigned clinical sites, partnering with site staff to identify and escalate or resolve compliance issues, and escalation of site questions or needs.
Supervise screening & enrollment at assigned clinical sites.
Collaborate with Director of Clinical Affairs to identify project specific resourcing needs.
Routinely review site compliance data and work to identify compliance risks and issues.
Participate in site close-out activities for assigned clinical sites.
Ensure all appropriate site staff are trained, informed of data collection, GCP, protocol and reporting requirements.
Conduct qualifications, initiation, interim and close out visits.
Responsible for the development, implementation, and execution of the clinical study monitoring plan.
Generate and use specific metrics to measure compliance with monitoring plan and deliverables and ensure compliance with the plan and all assigned tasks throughout the study.
Ensure project deliverables/milestones are met through oversight of all in house and field monitoring activities on a project level for all phases of the clinical project.
Conduct thorough comparison of case report forms against medical records at multiple sites.
Address non-compliance issues and trends at investigative site; develop, document and implement CAPAs as necessary.
Conduct device accountability at clinical sites.
Ensure that all adverse events are identified and clearly documented during visits
Quality and Process Improvement:
Identify and report complaints.
Identify and ensure communication of the need for corrective action at clinical sites.
Ensure training is completed per the required timelines and project needs.
Identify process improvement opportunities. Independently propose solutions/plans.
Performs other duties and responsibilities as required.
Knowledge, Skill, and Ability:
Must understand the scientific process, clinical research processes and have command of medical and statistical concepts
Ability to think strategically
Must have strong analytic skills and ability to make data driven decisions.
Desire to work independently and ability to seek guidance as needed.
Must have good communication and presentation skills (verbal and written) and computer/database management skills.
Combination of clinical and basic science research experience
Working knowledge of GCP regulations for medical devices
Working knowledge of FDA IDE/PMA regulations a plus
Must be collaborative and able to function as an integral part of small and large teams
Set the standard for personal integrity and work ethic; show high levels of initiative and looking for opportunities to contribute to team objectives.
This position will require 20-50% travel.
Health Science degree (preferably an advanced degree) or
Clinical Research degree
5 years of medical industry experience in clinical trial research
About The GID Group
The GID Group, Inc. is a global leader in cellular medicine, offering a tissue processing platform that enables cell-based treatments for a broad range of therapies. Our team of seasoned executives, adipose tissue scientists and surgeons work together to discover reliable, cost-effective solutions that utilize the patient's own cells to heal them.