Senior Clinical Research Associate (Remote)

Stryker is seeking to hire a Senior Clinical Research Associate for Stryker’s Neurovascular division to be based remotely anywhere in the United States.

Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. If you join our organization; will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

Who we want

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As the Senior Clinical Research Associate, you work closely with Program Management to delivery high quality site monitoring and management for the Study Operations team within Clinical Shared Services. This will include clinical operations activities through the coordination of our global Clinical staff or within a geographic region.

• Demonstrate the ability to work in a fast-paced environment and provide leadership to others on the team.

• Take initiative and complete tasks with high attention to detail and accuracy.

• Proactively communicate with investigators, colleagues, and vendors to ensure clinical quality and compliance.

• Take great pride in mentoring others and delivering high quality results.

• Possess a broad perspective and solid understanding of the clinical research processes.

• Provides appropriate sponsor oversight of sites and mentorship to junior team members.

• Works independently with minimal guidance and direction.

• Conducts clinical research activities in accordance with Stryker SOPs and applicable regulations/guidelines.

• Supports activities within various phases of clinical studies (i.e. study planning, site qualification and investigator selection, monitoring, closeout, etc.).

• Manages overall clinical site activities by providing oversight and guidance to CRAs for site activities in accordance with the Protocol, Monitoring Plan, Good Clinical Practice (GCP), ICH guidelines and federal regulations.

• Oversees contract research organization (CRO) personnel site activities and overall vendor performance.

• Supports the development of clinical study plans, presentations, study documents, contracts, development and design of CRFs.

• Leads review of clinical data listings for completeness and accuracy and escalates issues to the CPM or above as appropriate.

• Provides co-monitoring and other shadowing opportunities to junior members of the team for training and development purposes.

• Develops and implements enrollment and recruitment strategies.

• Maintains a high level of professional expertise through familiarity with scientific literature, product portfolio and competitive environment.

• Builds and maintains great working relationships with KOLs and Study PIs.

• Reviews monitoring visit reports and tracks resolution of action items.

• Identifies noncompliance and implements preventative and corrective actions.

• Recommends process improvements to increase team efficiencies and effectiveness.

• Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements Complete all training requirements on time.

What you need

• Bachelor’s Degree (B.S. or B.A.) required.

• Registered Nurse or bachelor’s degree in Nursing - preferred

• 4+ years’ relevant work experience in a clinical study operations role (i.e. Clinical Trial Coordinator, Clinical Research Associate, or Clinical Trial Scientist) required.

• 3+ years (36 months) of demonstrated independent site management responsibilities and data monitoring (source data verification) as a Clinical Research Associate (or equivalent title) experience required for a sponsor or CRO organization required.

• Medical Device or Pharma experience required.

• Previous site monitoring experience including conducting Site Qualification Visits, Site Initiation Visits, On-site AND Remote Interim Monitoring Visits.

• Experience performing Site Close-Out Visits preferred.

• Previous Study Start-up experience including timely activation of sites to enroll, for both Central IRB sites and Local IRB sites.

• Working knowledge of GCP/ICH guidelines, federal and local regulations required.

• ACRP CCRA Certification or SOCRA CCRP Category 3 Certification strongly preferred.

• Global clinical trial experience and EUMDR working knowledge preferred.

This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.