Clinical Research Associate (Remote-Home Based)Together with the Clinical Operations Manager, you will support the execution Clinical Trials for the Hospital Patient Monitoring (HPM) Business. This involves being confident with regulatory compliance and quality management related topics, to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.Your role:
Owning the overall study process and adherence to clinical trial procedures by keeping oversight, identifying possible problems/risks, creating mitigation plans, and taking actions or corrective actions using timely communication for daily monitoring and site mgmt.
Supporting site identification, selection, i.e. recruitment and qualification, and initiation. As well, developing the monitoring plan for clinical studies.
Supporting electronic data capture (EDC) user acceptance testing and training as applicable, while liaising with project team members regarding study site issues. As well as assisting with resolution of investigational site/data queries.
Contributing to the ICF creation, initiating study status reports, essential documents, and accurate study files, while supporting the development of regulatory binders and investigational product shipments as needed.
Traveling to study sites for meetings and monitoring visits upon request (i.e. 60% travel of which 10% international).
You're the right fit if:
You’ve acquired 2+ years related experience in (conducting) clinical trials (healthcare setting, CRO, medical device and or/or in medical technology and or industry. (2+ years monitoring experience preferred.)
You have a bachelor’s degree, in biological sciences or healthcare
Your skills include a demonstrated working knowledge of GCP, ICH guidelines, FDA/EU regulations.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
You’re autonomous, fluid and have the ability to follow through on timelines, projects and related tasks with limited direction. You have a proven track record for collaborating across multiple cross functional teams and are a strong and efficient communicator, both written and verbal.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.Philips Transparency DetailsThe pay range for this position is $66,000 to $130,000, annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran