We are currently seeking a clinical research associate to join our trauma and extremities division to be in remotely anywhere within the mid-west, central or east coast region of the united states.
Who we want:
Dedicated achieversPeople who thrive in a fast-paced environment and are driven to ensure a project is complete and meets regulations and expectations.
Meticulous documentersDetail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Self-directed initiatorsPeople who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Strategic thinkersPeople who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or identifying opportunities.
Collaborative partnersPeople who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
What you will do:
As a clinical research associate (cra), you will interact directly with institutions and investigators, and will drive research initiatives and ensure alignment with strategic goalsYou will be responsible for tasks that require a high degree of attention to detail and accuracyYou will be working with an international team of colleagues and investigators who are driven to deliver high quality results that make an impact on the quality of healthcare around the world.
Work in a virtual team environment, requiring that you be highly engaged, communicate effectively and maintain accurate and timely tracking and documentation.
Manages contracts, provides training on sops, and conducts monitoring activities, including site visits.
Responsible for ensuring operational aspects of the studies (such as documentation, payments, and other systems) are being conducted in accordance with gcp, food and drug administration regulations and department standard operating procedures.
Build and maintain excellent working relationships with kols and colleagues.
Ensure operational aspects of the studies are being conducted in accordance with all relevant ethical and government standards, gcps, and stryker standard operating procedures.
Maintain a high level of professional expertise through familiarity with scientific literature, product portfolio, and the competitive and healthcare environments.
Executes clinical trial research, evaluates and analyzes clinical data.
Maintain clinical and regulatory files, as well as clinical inventory intended for distribution to investigational sites.
Perform continuing training as sops and study procedures change.
Development and preparation of monitoring plan and study/visit materials.
Calculate metrics on monitoring processes and suggest improvements.
Review adverse events forms and report observations to management.
Process and track investigator payments and patient reimbursements.
Coordinate activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
May draft materials including informed consent documents, draft source documents, patient instruction guides, protocols, and case report forms.
Perform site assessment, qualification, monitoring and co-monitoring, and site close-out activities as required.
What we need:
Bachelor’s degree required(bachelor’s degree in science, business, or health-related field preferred).
0+ years related work experience required.
1+ years related clinical trial associate, clinical study associate, clinical research associate or clinical research internship related experience preferred.
Previous medical device clinical trials experience 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.
