Clinical Quality Associate

Stryker is hiring a Clinical Quality Associate to support Trauma and Extremities! In this role, you will be part of an international and cross-functional team interacting directly with health care organizations and investigators and will drive research initiatives, ensure alignment with strategic goals, and deliver high quality results that make an impact on the quality of healthcare around the world.

This role allows you to work in a virtual team environment, requiring that you be highly engaged, communicate effectively and maintain accurate and timely tracking and documentation.

This is a virtual role seeking candidates in the Eastern or Central US time zones.

What you will do:

• Prepare, process, and track clinical invoices, including high risk payments, in accordance with contractual obligations and company policy. This includes working directly with investigative sites and HCPs to obtain reports prior to payment and collaborating with Accounts Payable for required follow through and reconciliation.

• Support clinical study initiatives as needed including but not limited to prepare, submit, and track Institutional Review Board/ Ethics Committee (IRB/EC) submissions, correspondence, and approvals, reporting of Adverse Events, and managing controls for shipping of study devices.

• Manage and facilitate the development, coordination, implementation and evaluation of new and ongoing clinical vendors including negotiating agreements, compiling and completing due diligence including adding to the Approved Supplier List (ASL), adding to the payment system (ERP), and follow through in integration and onboarding for use.

• Support operational excellence and inspection readiness within Clinical Affairs through meeting electronic Trial Master File (eTMF) requirements, managing conflict of interest activities, driving policy and procedure development and training, and collaborating across Stryker clinical divisions for best practice networking and knowledge sharing.

• Identify opportunities, specifically related to automation and quality objectives, for process improvement initiatives to streamline processes and save time and money, driving these initiatives to completion through collecting feedback, UAT, training, and tracking metrics.

• Provide strategic contracting support, in accordance with specified timelines, applicable laws, and SOPs, for the entire contract lifecycle including supporting requests for new research proposals, drafting and negotiating Clinical Trial Agreements, Amendments, budgets, and payment terms, managing any required amendments, extensions, terminations, and the associated due diligence, tracking, and filing.

• Manage consulting agreements and service engagements including drafting and storage of contracts, activity set up, management, and reconciliation of HCP service hours in accordance with the approved business needs.

• Support department financial activities including accruals, transparency reporting, tracking and routine reporting to leadership.

• Cross functional collaboration with external vendors and institutions, internal teams such as Accounts Payable, High-Risk Payments, Master Data Management, Legal, Compliance, and various leadership positions.

What you need:

Required:

• Bachelor’s degree in business, finance, or other relevant field of study.

• 2+ years of relevant experience, i.e., Quality, Regulatory, Invoice Management, Vendor Coordination, Contract Handling, etc.

• Experience in a Regulated Industry.

Preferred:

• Demonstrated working knowledge in applicable systems, including Microsoft Word, Excel, SharePoint, enterprise resource planning (ERP) systems, and contract management software.

• Demonstrated knowledge of legal contracts, payment processes, and vendor management.

• Fundamental knowledge and good understanding of GCP’s, clinical study development process and logistics.

• Excellent communication skills (both written and oral).

$77,200 - $160,800 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.