Senior Clinical Research AssociateKelly Services, Inc. - Redwood City, CA
Senior Clinical Research Associate
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 San Francisco area as a Senior Clinical Research Associate with oncology experience.
This position serves as a key role in the day to day management of a clinical trial. This individual will manage the study management team, vendors, clinical monitors, and clinical trials sites.
Designs and develops clinical studies and respective documents for company products
Assists in the selection of investigational sites, negotiates grant contracts with each, and conducts site training for the study
Assists in the setting and updating study timelines.
Assists in CRO or vendor selection.
May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports.
Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
Interfaces with individuals in other functional areas to address routine study issues.
May be asked to assist in the training of Clinical Trial Assistants.
May conduct site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
Assures site compliance with the routine protocol and regulatory requirements and quality of data.
May resolve routine monitoring issues.
Performs all site monitoring to assure protocol and regulatory compliance, and the timely submission of complete and accurate study data forms
Assures the creation of complete and accurate databases for clinical studies
Conducts analyses of study data and write clinical summaries as needed to support claims of safety and efficacy.
Monitors case report forms, identifying and resolving discrepancies
Tracks clinical trial documentation and retrieve, process and tabulate clinical or study compliance data to ensure smooth initiation, operation and timely completion of the clinical trial
A minimum 4 years direct CRA experience in the pharmaceutical industry or equivalent in clinical study management
Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
Excellent organizational skills
Very good communication skills to interact with key contributors including but not limited to physicians and clinical staff to communicate technical information both verbally and in writing
Ability to use a variety of software programs (MS Office)
Ability to manage multiple tasks simultaneously
Experience in multiple phases (e.g., I, II, III) and multiple stages (e.g., startup, maintenance, close out) of clinical operations desirable
Monitoring and/or site/ study management experience
Experience in a regulatory environment desirable.
Demonstrated competence in standard business procedures (SOPs, Global Regulations)
Bachelor’s degree or equivalent is required, typically in nursing or scientific field, advanced degree is desirable
6 month contract
**If you meet the minimum required skillsets…
Please apply now for immediate consideration!
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.
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
Kelly Services Jobs
11 days 10 hours ago
applySenior Clinical Research Associate Kelly Services, Inc. - Redwood City, CA, United States
William Russell Kelly founded the company in Detroit on October 7, 1946, operating as the Russell Kelly Office Service. He is widely credited with pioneering the modern temporary help industry. The company was renamed Kelly Girl Service in 1957, and it became Kelly Services® in 1966 to reflect the growing services of the company. Established in the International Marketplace In 1968, Kelly Services opened its first international office in Toronto, Ontario, Canada. The company’s first European office opened in 1972 in Paris, France. Today, we offer a full suite of outsourcing, consulting, and staffing solutions—delivered globally from over a 70-year heritage of dynamic talent innovations. Total Sales Revenue in 2016 was $5.3 billion. Fortune U.S. Rank Kelly Services is currently ranked 490 in the Fortune 500 list of America’s largest companies.
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