Seeking a Study Director based in Lake Forest, CA. As a member of our team, you will direct clinical, non-clinical, and internal research projects, troubleshoot laboratory assays and develop new assays, and provide technical oversight for all aspects of the study, and provide scientific feedback to clients.
This is a full-time day shift position working Monday – Friday from 9:30AM-6:00PM.
Ideal candidates will be proficient in histology and immunohistochemistry (IHC), experience directing projects, and communicating with clients.
- Demonstrate an in-depth knowledge and expert understanding of the underlying technology.
- Provide scientific and technical oversight for all aspects of the study, including interpretation, analysis and documentation of results.
- Assure that all protocol amendments and deviations are documented and properly approved internally and by the sponsor.
- Participate in calls, videoconferences and meetings with sponsors, clinical trial site personnel, quality assurance auditors, and regulatory inspectors.
- Lead presentations for clients.
- Ensure that the study is properly conducted in compliance with the study protocol.
- Work with project management team to ensure projects are completed on time.
- Review study data to ensure that it is of high quality, identify any potential concerns, investigate and resolve.
- Prepare, review or contribute to study reports. Prepare, sign and approve the final study report to indicate acceptance for responsibility and validity of the data.
- Interact with clients to sell our services, design studies, and develop study protocols.
- Ensure response to QA department audits and that any findings are addressed properly.
- Follow procedures in accordance with relevant GLP, GCP, CLIA and state laws and guidelines.
- Maintain a work culture which is focused on customer service, the highest quality results and meeting deadlines.
- Take an active role in advancing the company's overall goals, objectives and growth.
- M.S. or Ph.D. degree in the sciences with the ability and experience to fulfill the job description
- Experience working in a GLP or CLIA laboratory.
- Proficiency in histology and immunohistochemistry. Must be able to direct projects using these technologies, communicate results to clients and troubleshoot.
- Knowledge of FISH, ISH, immunofluorescence and image analysis is preferred.
- Having the ability to identify cancer and normal cell types under a microscope.
- Knowledge of immune cell phenotype markers (e.g. CD3, CD20) is preferred.
- Having knowledge of methods of processing cancer tissue, cell culture related assays, and molecular assays.
- 2+ years of experience managing projects for pharmaceutical or biotech companies and meeting deadlines.
We are a leading provider of pre-clinical and clinical trial services to the pharmaceutical and biotechnology industry. Our laboratory service offerings include histology, immunohistochemistry, immunofluorescence, ISH, FISH, CTC isolation and characterization, chemosensitivity testing, tissue procurement, ELISA, mutation testing, cell expansion, and colony forming assays.
We are a CLIA licensed and CAP accredited laboratory, and we perform studies in compliance with the relevant portions of Good Laboratory and Good Clinical Practices.
We care about our team and offer a wide range of benefits including:
- Competitive wages
- Medical, dental, and vision benefits
- Life/AD&D benefits
- Additional voluntary benefits
- 401k retirement savings plan with a healthy match
- Vacation and sick time
- Career development opportunities
- Continuing education
- Free snacks
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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