As a regulatory professional, confidence comes from having the answers you need. But what do you do when the answers just aren't there? 2014 RAPS will give you the know-how to tackle your toughest issues.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
CCRA (Certified Clinical Research Associate), CCRC (Certified Clinical Research Coordinator), CPI (Certified Principal Investigator), CCRP (Certified Clinical Research Professional), CIP (Certified IRB Professional)
Here, it’s different.
We're not just leading transformative research for the sake of innovation. We're using it to pioneer groundbreaking treatments with the hope of eradicating childhood disease and changing pediatric medicine-giving all kids a chance at a healthier future.
The Clinical Research Regulatory Specialist is responsible for the overall management of clinical research protocol documents and activity from initial submission through study closure. The primary focus is on the development, submission, maintenance, filing and reporting of regulatory documents while achieving and maintaining compliance with all internal, external and federal policies and regulations that apply to research involving human subjects. The Clinical Research Regulatory Specialist provides regulatory guidance and direction to all members of the research team at Children’s Hospital Colorado in order to ensure compliance with all applicable policies, procedures and regulations.
This position is part of the CCBD's Bone Marrow Transplant research program and reports to CCBD's Clinical Research Manager. The BMT program is growing rapidly and we are hiring for all research positions. Please refer to the career's site for additional openings.
Ability to work independently; organize, plan and adjust work assignments while meeting deadlines
Able to coordinate multiple projects of varying complexity simultaneously and work efficiently to meet department and Investigator timelines
Demonstrated ability to establish and maintain effective working relationships
Previous experience in a healthcare or clinical research related field and/or an understanding of medical terminology and IRB submissions
Thorough knowledge of word processing and database development required
It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information.
Children's Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years. Founded in 1908, Children's Colorado is a leading pediatric network entirely devoted to the health and well being of children. Continually recognized as one of the nation's outstanding hospitals by U.S. News & World Report, Children's Colorado is known both for its nationally and interna...tionally recognized medical, research and education programs as well as the full spectrum of everyday care for kids throughout Colorado and surrounding states. With more than 1,000 healthcare professionals representing the full spectrum of pediatric specialties, Children's Colorado Network of Care includes its main campus, 16 Children's Care Centers and more than 400 outreach clinics.
A career at Children's Colorado will challenge you, inspire you, and motivate you to make a difference in the life of a child.