Benefits include: Medical, Dental, and Vision Insurance, 401(k), Stock Options

NOTE: You must have a minimum of 3-5 years prior experience combined in-house and field monitoring 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 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 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 variable site monitoring, with travel requirements that may fluctuate depending on study needs, and frequent interaction with surgeons and their staff. The CRA typically is the first point of contact with clinical research sites
• Will monitor clinical sites directly or support clinical monitors as part of a team for on-site or remote visits to monitor for adherence to protocol and GCP.
• In tandem with the clinical study team, supports study financial activities that include quarterly or ad-hoc invoice generation, payments and study payment tracking.
• Responsible for site regulatory document collection, filing of study documents in trial master file (TMF), ICF review/approval, IRB/EC submission (including annual submissions), 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.
• Will serve as the subject matter expert with the EDC to manage questions or other data query issues at the site level.
• Supports efforts geared to prepare clinical sites for regulatory inspections.
• Collaborates effectively within clinical, and cross-functionally, as necessary to develop solutions and processes to resolve complex trial issues.

QUALIFICATIONS:

• Minimum of 3-5 years prior experience combined in-house and field monitoring. Medical
  device experience in spine and/or implantable device industry 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