Clinical Research Associate, Level 1
Stryker
Stryker is currently seeking a Clinical Research Associate (CRA) - Level 1 to join our Trauma and Extremities Division remotely anywhere within the Central or East Coast region of the United States.
**What you will do**
As the **Clinical Research Associate (CRA) - Level 1** , you will interact directly with institutions and investigators and will drive research initiatives and ensure alignment with strategic goals. You will be the primary point of contact with site staff and will be responsible for managing the site throughout all phases of the clinical study, including selection and initiation of sites, as well as conducting and closing activities of the appointed studies. You will be responsible for tasks that require a high degree of attention to detail and accuracy. You 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.
+ Administer protocol and related study training to assigned sites, evaluates the quality and integrity of study site practices related to proper conduct of the protocol and adherence to applicable regulations.
+ Manage the progress of assigned studies by tracking regulatory submissions and approvals, study enrollment, data completion and submission, as well as resolution of data discrepancies.
+ Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans.
+ Demonstrate strong interpersonal, written and oral communication, organization, time management and planning skills in a fast-paced environment.
+ Ensure operational aspects of the studies are being conducted in accordance with all relevant ethical and government standards (e.g., ISO, FDA, etc), GCPs, and Stryker Standard Operating Procedures.
+ Maintain clinical and regulatory files, as well as clinical inventory intended for distribution to investigational sites.
+ Conduct site monitoring (e.g. site selection, site initiation, interim monitoring and closeout visits) and site management activities.
**What you need**
**Required**
+ Bachelor’s degree (B.S. or B.A.), preferably within Health Sciences or other related technical discipline
+ Minimum 2 years of experience in a clinical research experience as a Clinical Research Coordinator, Clinical Trial Coordinator or Clinical Research Associate
+ Fundamental knowledge and good understanding of GCPs, clinical study development process, and logistics
**Preferred**
+ Certificate Degree in Clinical Research or CCRA (Certified Clinical Research Associate) credentials
$77,200 - $160,800 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
This role will be posted for a minimum of 3 days.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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