Job Overview: NovelMed, a pioneering biotech company in Cleveland, Ohio, is seeking a talented Clinical Research / Regulatory Affairs Associate to join our dynamic team. This role is pivotal in advancing innovative therapies through meticulous clinical research coordination and stringent regulatory compliance, contributing to the development of groundbreaking treatments in the pharmaceutical sector. Key Responsibilities: You will assist in preparing and submitting regulatory documents, including IND applications, amendments, and annual reports to the FDA and other agencies. Collaborate with cross-functional teams to design and execute clinical trials, ensuring adherence to GCP, ICH guidelines, and protocol requirements. Monitor study progress, manage adverse event reporting, and maintain comprehensive records for audits. Support investigator site interactions, contract negotiations, and IRB submissions while staying abreast of evolving regulations to mitigate compliance risks. Required Qualifications: A Bachelor's degree in Life Sciences, Biology, Chemistry, or a related field is required; advanced degrees or certifications like RAC are highly preferred. Minimum of 2-3 years of experience in clinical research or regulatory affairs within biotech or pharmaceuticals. Familiarity with FDA regulations, 21 CFR Part 11, and electronic data capture systems is essential. Skills: Proficiency in Microsoft Office Suite, regulatory software such as Veeva or MasterControl, and data analysis tools. Exceptional attention to detail, strong organizational skills, and the ability to manage multiple priorities in a fast-paced environment. Excellent written and verbal communication skills for interacting with internal teams, external vendors, and regulatory authorities. Knowledge of clinical trial methodologies, biostatistics basics, and risk management strategies. Company Info: NovelMed is at the forefront of biotech innovation, specializing in novel therapeutics for rare diseases and unmet medical needs. Based in Cleveland, OH, we foster a collaborative culture driven by scientific excellence and patient-focused outcomes, with state-of-the-art facilities supporting end-to-end drug development. Benefits: We offer competitive compensation, comprehensive health, dental, and vision insurance, 401(k) matching, generous PTO, and professional development stipends. Enjoy wellness programs, flexible work options, and team-building events in a supportive environment. Growth Opportunities: Advance your career through mentorship programs, leadership training, and opportunities to lead projects in clinical operations or regulatory strategy. Join us to grow with a company poised for expansion and impactful contributions to global health.