Regulatory Specialist - Clinical Research

CenExel Clinical Research is seeking a Regulatory Specialist - Clinical Research to join their team. The successful candidate will be responsible for preparing, organizing, and implementing regulatory research documents in accordance with FDA guidelines, ICH GCP, and SOPs. They will also be responsible for maintaining regulatory documents, coordinating investigator and study staff training, and ensuring compliance with regulations and company guidelines.

Requirements

• 1+ years of regulatory experience in clinical research
• High school graduate or GED equivalency
• Demonstrated prioritization and organizational skills
• Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs
• Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others
• Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner
• Computer skills using PC platform computers with proficiency in Excel and Word
• Ability to learn and become proficient in eRegulatory systems, IRB portals, vendor portals, and sponsor portals
• Critical thinking skills with strong attention to detail and superb problem-solving abilities
• Ability to effectively communicate verbally and in writing

Benefits

• Health Insurance
• Dental
• Vision
• LTD
• STD
• Life Ins
• 401k