Manager, Regulatory

As a Manager at Velocity Clinical Research, you will play a crucial role in study start-up activities, focusing on regulatory compliance, source document delivery, and ensuring timely submission of key documents to facilitate study initiation. Your responsibilities will include managing a team of regulatory specialists, proactively addressing regulatory challenges, driving efficiency, and ensuring that regulatory submissions are completed promptly to avoid delays in study start-up. You will be involved in preparing study-specific protocol documents, informed consent forms, HIPAA authorizations, and other necessary materials for review by the Institutional Review Board (IRB). Additionally, you may be responsible for submitting protocol amendments, annual requests for continuing protocol approval, adverse event reports, and other IRB-required documentation. Your role will also involve guiding staff members on completing conflict of interest paperwork and maintaining the study binder with all IRB-related documents. As a proactive and innovative leader, you will work towards breaking down barriers, meeting corporate objectives, and identifying potential gaps in study start-up processes to ensure smooth operations. Your ability to think out of the box, provide mentorship, and develop regular progress reports for executive management will be crucial in achieving study start-up milestones. You will collaborate with auditors, maintain electronic regulatory files, coordinate meetings, ensure compliance with regulatory trends, and uphold safety and compliance regulations. Moreover, your attention to detail, problem-solving skills, and adherence to regulatory requirements such as ICH, GCP, and FDA guidelines will be essential in maintaining binder accuracy, completeness, and inspection readiness. In addition to technical proficiency in using computers, Microsoft Office software, and other relevant technologies, you are expected to possess advanced verbal and written communication skills, organizational abilities, and a strong aptitude for working in a fast-paced environment. Your capacity to mentor, train, and lead a team, along with a minimum of four to six years of clinical research regulatory experience and previous supervisory experience, will be advantageous in excelling in this role. Please note that this job description serves to outline the general functions of the position and may not encompass all specific tasks and duties required. Tasks and responsibilities are subject to change based on company needs and circumstances. All employees are expected to perform their duties to the best of their abilities as required by the job and management's requests.,