Job Description

Stryker is hiring an **Associate Clinical Study Manager** to support our **Trauma & Extremities division** ! In this role, you will assist with the planning, execution, and oversight of one or more clinical studies. As an integral part of the Clinical Research team, you'll support key project activities, helping ensure patient safety, data integrity, and compliance with all applicable SOPs and regulatory requirements. You will play a critical role in keeping studies on time and within budget. This is a virtual role, seeking candidates in the **Eastern** or **Central US time zones.** **What you'll do:** + Serve as the direct point of contact for investigator sites and build strong working relationships with clinical site staff, key opinion leaders and colleagues. + Support new and ongoing clinical research activities, ensure efficient and timely processing of confidentiality and clinical agreements. + Supports the clinical project plan, including study budget. Writes and develops the protocol, informed consent and other study specific documents. + Manages site nomination, qualification, and selection process. Conduct on-site monitoring and study closeout visits, write reports and site correspondence, co-monitors (trains and evaluates) other CRA's and CSC's. + Conduct clinical monitoring and/or auditing of field sites to supervise and coordinate clinical studies. + Designs, develops, and tests the CRFs and databases in collaboration with the clinical study manager and study data manager. + Manages site regulatory submission and approval process. Responsible for country regulatory submission and approval internally or with vendors. Collects, files and tracks site regulatory documents. + Supports management of clinical data and regulatory reports, and timely management of study publications. + Ensure studies are conducted in compliance with GCP, SOPs, and all applicable ethical and regulatory standards. + Perform periodic audits of study files for completeness and support SOP development and training as procedures evolve. + Process and track site payments and patient reimbursements + Participate in continuous improvement activities and process re-engineering projects in support of continual improvement initiatives **What you need:** Required: + Bachelor's degree required. Preference for degrees in health science, biological sciences, engineering, or related medical/scientific field. + 2+ years' experience directly supporting clinical research or similar experience in a medical/scientific area. Preferred: + Expertise with GCPs and regulatory and compliance guidelines for clinical trials. + Experience in site management, monitoring, and clinical documentation systems. This role may require up to 50% travel, though this represents the upper end of the travel expectation. $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. 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.

Job Tags

Temporary work, Flexible hours,

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