Philips Clinical Research Associate in Murrysville, Pennsylvania
The 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 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.
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 report
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
Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Headquartered in the Netherlands, Philips' health technology portfolio generated 2015 sales of EUR 16.8 billion and employs approximately 69,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
We are looking for
2 years’ experience as a clinical research associate monitoring clinical trials in healthcare setting, CRO, medical device and/or pharmaceutical company and/or industry
Bachelor’s degree, in biological sciences or healthcare preferred
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 accurately and thoroughly
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.
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.