Clinical Research Associate
: Job Details :

The Science Team at Russell Tobin & Associates supporting the Pharmaceutical Industry that has an opening for Clinical Research Associate in Seattle, WA (Need local candidate only)

Position Summary:

The incumbent is responsible for providing day-to-day support for clinical studies. This role supports the clinical operations project team to facilitate the planning, execution, and closeout of outsourced clinical trials. The incumbent will ensure trials are conducted in compliance with the protocol, ICH Good Clinical Practice (GCP), applicable regulatory requirements, and internal standard operating procedures (SOPs). This position may also manage specific study and operational tasks, including vendor management responsibilities.

Additional Details:

Contract Length: 6 months with the possibility of extension

Pay range: $33to $53/hour on W2 as per experience

Key Responsibilities

• Develop and distribute meeting agendas, minutes, and monthly status reports to document key project updates and communications to stakeholders. Support communication with CROs, vendors, and investigator sites.
• Assist with study start-up activities, including preparation and/or review of study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines, study logs and forms, site contracts and budgets, vendor contracts and budgets, etc.).
• Track subject recruitment at study sites, monitoring visits and approvals, as well as protocol deviations, infringements, and other compliance-related issues. Provide updates to CROs and sites on global study information.
• Assist with the collection, review, and filing of site essential documents and maintenance of the Trial Master File (TMF). Support tracking of clinical supplies at sites through IWRS, EDC, and CTMS systems.
• Follow international GCP guidelines, regulations, and SOPs to support study execution. Assist in risk assessment activities, review of corrective action plans, and planning of quality assurance activities, audits, and inspections. Coordinate communication of findings.
• Participate in team meetings, CRO/vendor/site teleconferences, and investigator meetings as needed.
• Escalate out-of-scope issues to the Clinical Trial Manager promptly.

Basic Qualifications:

• Bachelor's degree in biomedical sciences or a related scientific discipline.
• Minimum of 2 years of clinical research experience.
• Demonstrated experience working with clinical protocols and operating in a clinical environment.

Knowledge, Skills, and Abilities:

• Strong verbal and written communication skills.
• Excellent organizational, multitasking, and time management abilities.
• Working knowledge of ICH GCP guidelines.

Must be authorized to work in the United States.

Russell Tobin offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

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About Us

Russell Tobin is a leading minority-owned professional and technical recruitment and staffing advisory organization.

We are comprised of specialized practices focusing on a variety of skill sets and industries. Having a depth and breadth of industry expertise, our subject matter experts are able to provide tailored and swift sourcing solutions to fulfill client hiring needs. In other words, we connect top talent with companies.

We are the staffing arm of the Pride Global network, a minority-owned integrated human capital solutions firm, with additional offerings in vendor management, payroll programs, and business process optimization.

As a certified minority-owned business, Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.

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