Specialist, Regulatory Operations

Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience Minimum of 2 years of experience in operational regulatory affairs within the research site, or CRO/pharmaceutical industry Understanding of U.S. regulations and ICH GCP guideline as they relate to site operations Good knowledge of site-level regulatory requirements for clinical trials in the U.S. Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance Good verbal and written communication skills Team Collaboration Skills Good computer skills with demonstrated abilities using clinical trials database, MS word and excel Experience in electronics Investigator Site Files systems like (Florence, CRIO) Curiosity and passion to learn, innovate Friendly, outgoing personality with the ability to maintain a positive attitude under pressure High level of self-motivation and energy Ability to work independently in a fast-paced environment with supervision Must have a client service mentality Demonstrated success in managing IRB submissions Detail-oriented with good problem-solving abilities and a proactive approach to regulatory challenges Ability to handle multiple tasks in a fast-paced and constantly changing environment

Act as main regulatory operations contact for assigned studies Support regulatory compliance activities for U.S. clinical research sites Coordinate and perform IRB site level submissions and maintenance of approvals Review, and submit high-quality and timely IRB submission materials Ensures that Investigator Site File (ISFs) are completed, up to date, accurate and in compliance with GCP Collaborate with cross-functional teams to ensure regulatory requirements are met Identify process gaps, and support the development and improvement of new departmental processes