Senior Clinical Trials Specialist-Neurology

• Regulatory affairs management of clinical research activities.
• Establishes working relationships with investigators and research staff to facilitate communication and participation in research start-up procedures.
• Works as a part of a project team in the development and design of applications for support of clinical trials.
• Supplies regulatory assistance for the successful conduct of biologic, drug, and device clinical trials using human subjects.
• Interfaces with federal agencies and industry sponsors in the approval of Phase I, II, III, IV clinical research studies.
• Participates and provides input in interdepartmental, industry, and international project teams as the regulatory representative interpreting and applying regulations, guidelines, research/information available, and policies to enable the team to select the most effective start up.
• Research Development
• Submits Informed Consent, Human Subjects' Research Applications, DSMB, HIPAA compliance, Radiation and Biosafety, and other pertinent regulatory forms to the IRB for institution approval of clinical trials.
• Manages complex multiple project regulatory obligations and timeline restrictions.
• Completes and coordinates regulatory documentation for Investigational New Drug and Biologic License Applications.
• Communicates directly with FDA to provide input into new and/or ongoing clinical research programs.
• Establishes and maintains regulatory information and database systems both electronically and hardcopy.
• Assists with protocol development of investigator-initiated research.
• Training and Staff Development
• Communicates appropriate institutional and regulatory guidelines to faculty and staff.
• Creates SOPs for division consistency and provides regulatory consulting expertise to study team members.
• Identifies deficiencies and discrepancies in regulatory processes and provides staff training as needed.
• Performs random, for-cause, and regulatory committee-requested audits of research studies as appropriate to ensure compliance with applicable regulations and guidelines.
• Quality Control Improvement and Continuing Education
• Identifies potential for functional improvements in clinical research to meet changing regulatory and business environments.
• Maintains current working knowledge of federal, state, local, and institutional regulatory guidelines.
• Pursues professional development opportunities, including external and internal training.
• Attends regional or national industry/professional meetings, conferences, and workshops.

Minimum Qualifications:

Bachelor's Degree (or equivalent experience) and 5 years experience

*CA