Support PDF,DOC,DOCX,TXT,XLS,WPD,HTM,HTML fils up to 5MB
Organization TypePublic Interest
Years of Experience
Date Last Verified
ProfileLegal Counsel The candidate will be responsible for overseeing and addressing research related legal issues to ensure that the organization appropriately manages risk, including oversight and support for the company staff. Responsible for providing legal support to the Institutional Review Board and the firm, including addressing pharmaceutical, biotechnology, medical device or other life sciences issues, drafting and negotiating clinical trial agreements with industry sponsors, universities and other healthcare providers, informed consent and confidentiality forms, regulatory compliance and other related legal issues faced by those areas. Provides legal support for other legal transactions involving research and clinical trials. Collaborates with leadership to ensure there is an appropriate and thorough review of any identified issues followed by an appropriate resolution, and keeps abreast of all regulatory issues and proposals that impact firm for any of the foregoing subjects.
Qualification and Experience
Requirements : The candidate should have a Bachelor's Degree and Law Degree from an accredited law school. Must be licensed to practice law in Indiana. Must have a minimum of 3-5 years of experience practicing law, preferably health law experience in the areas identified above. Experience with research contracts, FDA and human subject research regulations, and Institutional Review boards beneficial. Must have excellent verbal and written communication skills. Requires broad knowledge of applicable federal and state privacy and information security laws. Requires knowledge of clinical trial and research regulations and issues. Must have ability to present complex information in a clear and understandable manner to small and large groups, including senior leadership, Boards and Board Committees.
Requisition Number: 129912