Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Clinical Protocol Coordinator to work at the National Institutes of Health in Bethesda, Maryland.
This is a long-term contract position which offers:
- Competitive salary with comprehensive benefit package
- Tremendous growth opportunity
- Opportunity to work at NIH, world's foremost medical research center
- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com
TASKS/SERVICES. The contractor shall:
Subject Matter Expertise on Regulatory and Protocol Issues:
- Complete required training courses and attend additional seminars to keep abreast of the latest development in human subject research policies and regulations, including:
- Research Coordinator Forum
- NIH Intramural Research program's Protocol navigation Training Program
- OHSRP Education Series
- Provide expert advice to Section staff on complex regulatory issues
- Provide regulatory guidance on the development of new protocols and protocol amendments.
- Contribute to weekly team meetings; provide current and upcoming information regarding regulatory issues.
- Maintain and update HCPS SOPs
- Maintain segment of weekly lab meeting regarding review and discussion of study events that occurred during the preceding week; take meeting minutes
- Work with investigators on the development of new studies; review proposals; draft MOPs; develop Case Report Forms in CTDB
- Serve as the primary point of contact with CTDB personnel; identify, follow up and resolve issues as they arise
- Review data organization with investigators at the end of the studies
Quality Control Activities:
- Perform routine quality control activities and internal audits, including downloading and reviewing all signed consent forms for all protocols, and reviewing all forms and notes in CTDB and CRIS for all subjects and all visits.
- Maintain “Data and Safety Monitoring Log” to track subjects' participation in research for all applicable protocols.
- Lead the preparation for audits; attend audits; respond to inquiries
- Provide orientation/training to investigators regarding NIH Policies, NINDS Policies, and HCPS SOPs.
- Facilitate the submission of training checklists and requests of privileges in CRIS and CTDB; provide training on how to use CTDB
- Oversee consent; document successful completion
- Remind investigators of required training; maintain a log of required training for all HCPS staff
REQUIREMENTS. The contractor must have:
- Master's degree in Life Sciences or other related discipline. Three (3) years of specialized experience plus a BA/BS degree is equivalent to a Master's degree.
- Three (3) years of experience in a related field.
- Expert knowledge of working in a research laboratory environment.
- Extensive knowledge and ability to analyze and evaluate research findings and learn new techniques.
- Strong communications skills, both oral and written.
- Excellent analytical, organizational and time management skills.
PLEASE APPLY ONLINE
Please visit www.kellycareernetwork.com to apply for this position. Due to the volume of inquiries, we regret that we cannot accept phone calls. Please also note that the phone number for our NIH branch is not listed.
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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