Kelly Services is URGENTLY seeking a Sr. Clinical Trial Specialist for a one year assignment that can be based in Raynham MA, Warsaw IN, or Cincinnati OH. Candidates should have sponsor Clinical Trial Lead experience, someone who can drive the execution of the US region in a global study. This includes reviewing monitoring reports and overseeing CRAs who are monitoring the sites.
Major Duties & Responsibilities:
- Monitors clinical studies for adherence to protocol, ICH/GCP, SOP's and follows Clinical Monitoring Plan i.e. on site quality visits, review & approve trip reports, monitor metrics of vendor/site performance.
- Ensures quality of data generated from clinical sites and assist in resolving subject eligibility/protocol deviations issues and confirms accuracy of clinical data. Works closely with CTM and Data Management lead to develop data quality plans and processes.
- Ensures safety issues are reported and follow up issues are closed within expected timeframe. Develops and maintains guidance and process instruction documents, maintain study documents (consent templates, site procedural instructions etc.).
- Responsibility to ensure site enrollment metrics are closely tracked to identify risk and elevate as appropriate to support enrollment goals. The tracking of essential documents are received /approved & filed for the duration of the study. Reviews/approves site ICF's for continuity and follow up with functional leads as appropriate.
Computer skills (Microsoft office; Word, Excel, PowerPoint
At least 4 years clinical research experience
Good organizational skills, good knowledge of concepts of clinical research and drug development
General therapeutic area education and training i.e. nursing, medical, strong problem solving skills and a good understanding of issue escalation, good communication skills, ability to functional well in team environment.
CRA field monitoring.
Preferred industry experience in Medical Device, Pharmaceutical, Biotech, CRO.
If you meet the qualifications above and are interested in pursuing this opportunity, please Apply Now!
Perks of being a Kelly employee:
- Weekly electronic pay
- Access to more than 3,000 online training courses though Kelly Learning center
- Group rate insurance options available immediate upon hire*
- Service bonus plan and holiday pay*
- Online application system
- Never an applicant fee
*perks to be received upon meeting eligibility requirements
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 90 of the Fortune 100 companies and found opportunities for more than 10,000 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.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. 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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