Clinical Research Associate
Job TitleClinical Research Associate
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
The senior clinical research associate performs and coordinates all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and Philips standard operating procedures. A clinical research associate monitors the clinical study and ensures that investigators follow the clinical trial protocol at all times to obtain high quality integrity data. The clinical research associate leads or provides oversight to third party CRAs involved with site monitoring. The Senior CRA will coordinate clinical study activities including development of protocols, preparation of informed consents, investigator brochures, sections of regulatory submissions, Case Report Forms and other study materials. Oversee internal and contract monitors, review clinical data, complete trend analysis, communicate study progress, risk, and best practices to study team. Coordinate and communicates with universities, contract research organizations, private practices, institutional review boards, and other functional groups engaged in the conduct of clinical studies.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
Key areas of responsibilities (KARS) for this role include:
- Responsible for data monitoring and study site management
- Responsible for overall study process and adherence to clinical trial procedures by keeping oversight, identifying possible problems / risks, creating mitigation plans, taking actions or corrective actions using timely communication
- Work according to Good Clinical Practice, rules and regulations and internal procedures
- Contribute to protocol development and study related documents such as informed consent related to monitoring activities
- Support site identification, selection, i.e. recruitment & qualification, and initiation
- Develop the monitoring plan for clinical studies
- Assure study site management; conduct data and study site monitoring activities for clinical studies, assure investigators and study site personnel adhere to the study protocol, applicable local regulations, ICH/GCP guidelines and SOPs, monitor study progress, executes close out activities and authors related reports
- Oversee and coordinate the work of third party CRAs (CRO-CRAs)
- Ensure compliance to ICH/GCP/local regulations
- Confirm and track that all key site personnel have project specific training
- Responsible for study status reports, essential documents, and accurate study files
- Support development of regulatory binders and investigational product shipments as applicable
- Assist with resolution of investigational site/data queries
- Liaise with project team members regarding study site issues
- Travel to study sites for meetings and monitoring visits upon request (ca. 40% travel of which 10% international)
- Other activities as assigned
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
This role will report to the Director of Clinical Operations.
Location: Monroeville, PA
We are looking for:
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
- Experience as a clinical research associate minimum of three years, five years preferred.
- Bachelor’s degree, in biological sciences or healthcare
- At least 2 years related experience in (conducting) clinical trials (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry)
- Good command of written and spoken English language
- excellent verbal and written communications skills
- excellent interpersonal and organizational skills
- a pro-active, committed and motivated attitude
- a demonstrated working knowledge of GCP, ICH guidelines, FDA/EU regulations
- ability to work very accurate and thorough
- excellent record-keeping skills; good documentation practice
- ability to maintain excellent working relationships with a broad range of trial staff.
- ability to work well in a team environment but also independently without significant oversight
- ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
- flexibility in work hours and readiness to travel.
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Find our more information about Philips at www.philips.com/na/careers
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.
In case of difficulties with your job application please send an email to [email protected]
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