Kelly Services Senior Clinical Research Associate in Seattle, Washington
Kelly Scientific Resources is the world's most recognized brand in Scientific Staffing with more than 100 locations in the North America, Europe and the Pacific Rim. Our scientists contribute to the research and development of products that are used daily in the home, such as medical devices or pharmaceutical products. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. We currently have an exciting opportunity in the Seattle/San Francisco area as a Senior CRA.
The Senior Clinical Research Associate role will support clinical trial management, site management, and data review and cleaning. Responsibilities include implementing trial set-up, execution, oversight and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.
The key deliverable for this role is to ensure timely, quality conduct of clinical studies according to protocols, Good Clinical Practice, Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.
The Senior CRA, reporting to the Associate Director, Clinical Operations and under the direction of the Clinical Study Manger, works closely with his/her cross functional team, to achieve study objectives and corporate goals. Primary responsibilities may include:
Manage defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
Develop strong working relationships and maintain effective communication within the Clinical Operations Group, as well as other functional departments within the company.
Act as a clinical trial lead to solicit contract research organization (CRO) RFPs, assist in identification of optimal CROs, and manage CROs or other study vendors.
Work closely with study site staff and field-based site CRAs.
Provide or assist with training for internal and field-based external CRAs, CRO team members, and investigative site staff.
Provide timely, quality study metrics to study teams using a variety of tracking tools (tables, databases, spreadsheets and files).
Conduct pre-study, study initiation, interim monitoring, and close out visits and complete associated monitoring visit reports as specified in department SOPs and study specific monitoring plans.
Review monitoring reports and monitoring visit letters from other CRAs.
Assist clinical study sites with study startup activities, including IRB and IBC submissions and ensure collection and review of required essential study documents and reports.
Develop or assist in preparation of supportive study supplies and documents (e.g., lab kits, lab manuals, imaging manuals, site study tools and worksheets, product administration guide, non-clinical supply materials, IXRS, etc.).
Work proactively with the data management team to design and develop paper or eCRFs and assist with writing CRF completion and monitoring guidelines.
Review completed eCRFs or data listings for accuracy, oversee data discrepancy management, and perform associated training/retraining as needed.
Monitor supply of investigational and comparator drug supply throughout the trial.
Assist with product accountability at site and take appropriate action to resolve discrepancies.
Maintain high level of familiarity with clinical literature in area of study.
Perform on-going review of the TMF to ensure files are properly maintained and archived.
Attend meetings, take and distribute meeting minutes.
4+ years pharma/biopharma industry experience in complicated oncology drug development, hematology oncology or gene therapy trials.
2+ years on-site monitoring experience, preferably at large cancer treatment centers.
Global trial and CRO management experience is preferred.
Previous experience with electronic data capture systems preferred.
Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures.
Demonstrated ability in positive relationship building, with strong verbal and written skills.
Strong interpersonal skills, ability to work within a team, and attention to detail.
Good analytical and assessment skills, judgement, and problem solving skills.
Ability to travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 30%).
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems.
BS/BA in Life Science or related discipline, nursing background desirable.
Minimum 5 years experience
12 month contract
Please apply now for immediate consideration!
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm