Clinical Research Associate, Senior

Benefits Medical, Dental, and Vision Insurance, 401(k), Stock Options NOTE: You must have a minimum of 5+ years prior experience in clinical operations role to be considered for this position (medical device experience in spine and/or implantable device industry strongly preferred). Providence Medical Technology, Inc. is a privately-held medical device company focused on innovation solutions for cervical spine conditions. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market. Our purpose is to improve clinical outcomes for high-risk patients and prevent surgical failures of the cervical spine.

LOCATION

This is a remote position.

SUMMARY

The Senior CRA is responsible for managing operational aspects of the company’s ongoing clinical trials, in line with PMT’s corporate directives and under the direction of study management. This position is expected to be able to meet on-time and on-budget deliverables while ensuring compliance and quality. The responsibilities include managing and monitoring study sites, maintaining regulatory compliance, contributing to clinical study reports and collaborating with all stakeholders to ensure study success. PMT is a data-driven company, therefore the Senior CRA is also encouraged to improve traditional clinical trials processes with new ideas and to question convention.

MAIN RESPONSIBILITIES:

Manage and coordinate in-house clinical operations activities for company’s ongoing clinical trials, including site startup, ongoing management during study conduct, and site close-out activities. This will include occasional site monitoring and frequent interaction with surgeons and their staff. Work with and support contract Monitors and will monitor clinical sites on site or remotely for adherence to protocol and GCP. May serve as site manager and company interface for active study sites. Support study financial activities that include quarterly payment reconciliations. Responsible for site regulatory document collection, filing of study documents in trial master file (TMF), ICF review/approval, IRB/EC submission (including annual submissions), payments tracking, study supply management (as appropriate), study communication, field training and support Responsible for implementation of clinical study documents as needed, including but not limited to: ICFs, amendments to study protocols, SOPs, Work Instructions (WIs) and study-specific forms, to ensure appropriate compliance with site start-up and initiation process and applicable regulations. Reviews sample, investigator-prepared and IRB-approved informed consents Assists with the design, format and content of study guides and subject instructions. Coordinates the activities associated with site startup. Interfaces with in-house data and EDC/CTMS management to ensure seamless study execution. Supports clinical dossier preparation for CEC meetings. Supports efforts geared to prepare clinical sites for regulatory inspections. Collaborates effectively within and cross-functionally as necessary to develop solutions and processes to resolve complex trial issues.

QUALIFICATIONS:

Minimum of 5+ years prior experience in clinical operations role. Medical device experience in spine and/or implantable device industry strongly preferred. Strong project management skills with an entrepreneurial attitude Proficient with clinical trial management software including EDC, eTMF, CTMS Prior experience with IDE clinical trial and international regulatory process required including FDA; ICH and ISO:14155. Prior experience with clinical trial contracting and start-up process required including EC/IRB submission process (central and local IRBs) Strong communication and problem-solving skills. Self-motivated, team player, with excellent time management skills Computer literate with a working knowledge of G-suite tools Our Mission is to establish Circumferential Cervical Fusion (CCF) as the standard of care for high-risk patients. #J-18808-Ljbffr Providence Medical Technology, Inc.