In this role, you have the opportunity to
Senior Clinical Research Associate (CRA) actively drives the execution of clinical trials in accordance with applicable regulatory standards and company requirements. Senior CRAs ensure adherence to the protocol, corporate objectives, regulatory compliance, and professional integrity for our internal and external stakeholders.
You are responsible for
Work closely with the Project Manager to execute the successful conduct of assigned studies consistent with the processes and procedures, clinical strategy, project plans, and protocol
Work with representatives from key functional groups including Field Monitoring, Quality Affairs, Product Development, Manufacturing, Sales, Marketing, Customer Service, Regulatory Affairs, R&D, and European Clinical Groups
Preparation of study related material and training materials
Perform site qualification and facilitate training of investigators, site staff, and study team
Work with Project Manager to develop study plans per our processes
Review and verify adequacy of center activation documentation
Work with study team to ensure sites comply with protocol and regulations, and the timely receipts of accurate data and required study documents
Review monitoring reports. Identify discrepancies in reports and study files, and ensure correction activities are completed.
Provide input to study budget and project plans
Oversee the organization of the of the Trial Master File and Site Files
Active oversight of corelab and vendors to ensure the scope of work is being performed accurately, within timeline and budget
May perform audits of monitoring, site files, CROs, etc
Collaborate with safety group and data management group with deliverables and timelines
Active in oversight of all phases of a clinical study, from development, study startup, follow up phase, final results and analysis, and study close out
Understand, interpret, and utilize metrics and leading indicators to identify risks and engage in mitigations. Collaborate with the Project Manager on mitigations, and corrective actions, as applicable
Provide updates regarding study status, progress, and compliance to project team or management
Assist Project Manager in writing sections of PMA Clinical Reports
May assist in preparation of materials for CEC and DSMB meetings
Provide input to study budgets and project plans
Assist in validation and verification activities as needed
Comply with applicable FDA and international regulatory laws/standards, company-wide and departmental Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs)
Support development of department SOPs and work instructions
To succeed in this role, you should have the following skills and experience
Bachelor’s degree (technical or non-technical). Six or more years of experience may substitute for Bachelor’s degree
Minimum 5 years experience directly supporting clinical research or similar experience in a medical/scientific area. Master’s degree may substitute for 1 year experience
Working knowledge of computer applications and office equipment
Clinical Site Trial experience preferred – training on GCP, investigator, protocol and CRF training
Ability to work independently and as part of a team
High attention to detail and accuracy
Advanced written and oral communication skills
Able to manage multiple tasks
High standard of integrity
Proficient knowledge of medical terminology
Expertise with GCP and regulatory compliance guidelines for clinical trials. Working knowledge of clinical research methods for medical devices and regulatory pathways
Experience in clinical research protocols, reporting, regulatory submissions, and development of clinical research plans
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.