- Ensure the clinical studies are monitored and conducted according to procedures including up to date and complete trial master files, regular review of data, and assurance that monitoring reports and follow-up documentation are completed and updates uploaded in CTMS
- Qualifies, Selects, Trains and Monitors internal and external study Investigators and study documentation.
- Oversee and support the creation of the Purchase Orders (PO), trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation.
- Continuously improving the efficiency and compliance of Clinical research activities by streamlining day-to-day workflow and processes and identification and adoption of improved information management and project management applications and tools.
- BS/BA in Scientific or relevant Healthcare discipline and 3+ years related experience in conduct and monitoring of clinical studies (healthcare setting, CRO, medical device and/or pharmaceutical company and/or industry)
- A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
- Experience in using EDC/ CTMS and knowledge of information management and workflow management applications (such as SharePoint, excel, and Confluence) and demonstrated learning agility to learn new applications and tools to drive disruptive efficiency.
- Flexibility in work hours and readiness to travel. Travel may be up to 50% but typically no more than 25% per month.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
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Clinical Research Associate - Bothell, United States - Philips
Description
Job Title
Clinical Research AssociateJob Description
Strategically partner to monitor and manage clinical projects and clinical staff globally for both internal and external stakeholders to optimize product life-cycle. Manage study documents, materials, devices, financial documents and clinical trial management systems.
Your role:
You're the right fit if:
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
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 Details
The pay range for this position is $89,376 to $153,216 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 Information
US 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.
Company relocation benefits will not be provided for this position. For this position, you will reside in or within commuting distance to Cambridge, MA., or Bothell, WA., USA
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.