Kelly Science & Clinical®is working with a local Seattle based Pharmaceutical company with an immediate need for an Oncology Hybrid In-House / Travel CRA with at least 5 years of experience. This Pharmaceutical company has a flagship product for Prostate Cancer and is seeking an individual to join their team and their battle against cancer, taking it to greater heights!
Title: In-House / Travel CRA: Hybrid
:
Ensure the timely, high-quality conduct of clinical trials according to protocols, applicable guidelines and regulations.
Roles / Responsibilities:
Clinical Trial Knowledge and Expertise
Trial Management
Serve as a Liaison with Internal and External partners to ensure effective collaboration
Oversee planning of meetings, site visits, and drafting study related documents
Compliance and Regulations:
Experience and Knowledge of Regulatory requirements
Trial Monitoring experience: Compliance and Patient Safety
In-Person Site Assessment, Initiation, Routine and Close-Out visits
Completes accurate monitoring visit reports
Provides site guidance on any protocol related issues
Coordinates necessary activities required to set-up, monitor and close-out clinical trial sites.
Assists in the preparation of routing protocols, informed Consents, SOPs, and other appropriate documentation.
Develops training materials and conducts training for study implementation based on company policies and SOPs
Develops, reviews, and maintains key study documents to ensure adequate resource and reference documentation.
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits
Liaise with vendors
Contribute to study development and start-up process including reviewing protocols, design and review CRFs, prepare ICFs, develop study documents, organizing investigator meetings and working with management on monitoring strategy.
Develop clinical training program and maintain awareness of developments in the field of clinical research as needed
Other duties
Monitor clinical trial activities to assure adherence to GCPs, SOPs, and study protocols
Reviews regulatory documents as required and prepares site visit reports
Effective Communication and Stakeholder Management
Serve as Central Point of Contact for Investigators, Study Coordinators and other Stakeholders involved in clinical trials.
Work independently and also in a Team
Seeking experienced CRAs with at least 3-5 years of monitoring experience.
APPLY TODAY!
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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