Job Description

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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