Covance - Regulatory Specialist - Come be a part of our research team!

Honolulu Job posted on: 8/21/2008 With state-of-the-art Clinical Research Units, Covance has helped hundreds of drug development companies progress their compounds from preclinical to proof-of-concept studies. Each Clinical Research Unit has a dedicated team of professionals, including physicians, scientists, project managers, nurses and recruiters - whose mission it is to bring the miracles of medicine to market sooner.We are currently looking for a Regulatory Specialist for our Honolulu, HI clinical research facility to provide overall regulatory support and to maintain regulatory and IRB records associated with clinical studies.In this position some of your main responsibilities will be to:•Maintain accurate and complete regulatory documents for all clinical studies conducted in the division of clinical pharmacology.•Conduct regulatory affairs training for staff.•Prepare Volunteer Information and Consent Form(s) (consent form(s)) for upcoming studies that conform to current regulatory requirements and SOPs. Incorporate necessary medical information as provided by the Investigator’s Brochure/package insert, the Principal Investigator, and the Project Manager.•Submit all Informed Consent Revisions and protocol amendments for IRB approval.•Oversee tracking and reporting of all serious adverse events to IRB.•Consult with clients with regard to consent form language.•Ensure appropriate preparation for each IRB meeting, including agendas and study packets.•Facilitate FDA Inspections directed towards the IRB.Required Experience:•1-2 years related experience •Previous IRB or Study Coordination experience preferred•Additional experience may be substituted for education requirements  Required Education:•BS in medical or related field•Certified IRB Professional preferredCovance believes that their best-in-classemployees deserve first-class benefits. The Company offers anoutstanding benefits package including medical & dental insurance,tuition reimbursement, a 401(k) plan with a generous company match,short- and long-term disability, and life insurance, all of which areeffective on the first day of employment!Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. Save to job file |