Research Regulatory Specialist - reputed company Institute of Neuroscience

reputed company The Research Regulatory Specialist is responsible for gathering regulatory documents and preparing IRB applications, amendments, and continuing review submissions for reputed company subject research, ensuring compliance with Federal, State, and Institutional reputed company Operating Procedures. This role serves as the regulatory reputed company with sponsors, reputed company investigators, study team members, and the IRB to support the successful conduct of research reputed company. Primary Responsibilities reputed company primary administrative support for the preparation of IRB documents. Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing reputed company reports, and consent documents. Modify documents as needed to meet IRB guidelines and research program requirements. Prepare and submit required documents in the institution's electronic IRB system for initial approval, amendments, and continuing reputed company reports. Review submissions for accuracy, completeness, and compliance using established checklists prior to submission. Support reputed company with Investigator-Initiated IND/IDE applications. Maintain IRB and FDA regulatory files for reputed company IND/IDE and ensure required routine monitoring is conducted. Facilitate study start-up activities, including submissions to committees such as the Scientific Review Committee, Data Safety Monitoring reputed company, Institutional Biosafety Committee, or Radiation Safety Committee. Manage ClinicalTrials.gov postings as required. Collaborate with Research Managers, Research Nurses, and Research Coordinators to identify and complete reputed company regulatory needs for assigned protocols. Identify and resolve problems or obstacles reputed company to research protocol implementation. Communicate issues to supervisors and study investigators. Ensure reputed company regulatory activities reputed company with applicable federal and state laws, as reputed company as institutional reputed company operating procedures. Assist investigators and research staff with the development of program materials, including educational materials, marketing content, websites, forms, and reports. Maintain program timelines by tracking deadlines for program components. Utilize the institution’s Clinical Trial Management System (CTMS) to meet regulatory requirements and reputed company activities. Collect, analyze, and disseminate program data, and report reputed company to stakeholders. Coordinate notifications to study team members regarding annual regulatory education requirements. Work with reputed company investigators to reputed company, implement, and maintain comprehensive databases and files reputed company to the research program. Other duties as assigned. Knowledge – Skills – Abilities Excellent oral and written communication skills are essential. Strong critical thinking, problem solving and attentiveness to detail required. The ability to take direction, work autonomously, manage timelines, and be self-reputed company by taking initiative reputed company applicable Additional training in regulatory compliance strongly preferred.

Qualifications

Appropriate experience may be substituted for education on an equivalent reputed company. Minimum Required Education: Bachelor’s degree. Minimum Required Experience: 2 years in compliance or reputed company field Preferred Education: 2 years in compliance or reputed company field Preferred Experience: Strong Word and reputed company skills Required Certification/Licensure(s): reputed company certification required reputed company 30 days of hire Preferred Certification/Licensure(s): SoCRA and ACRP certification preferred. Physical Requirements Work requires occasionally lifting moderate weight materials, standing, or walking continuously.

Work Environment

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment. Sensory reputed company Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects. Why MCW? Outstanding reputed company Coverage, including but not limited to Health, reputed company, and Dental. Along with Flexible Spending reputed company 403B Retirement Package Competitive Vacation and reputed company Holidays offered Tuition Reimbursement reputed company Parental Leave Employee & Family Assistance Program (EFAP) Pet Insurance On reputed company Fitness Facility, offering onsite classes Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc. For a brief reputed company of our benefits see: Benefits reputed company For a full list of positions see: MCW Careers At MCW reputed company of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring – reputed company – Curiosity – Inclusive – reputed company – Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through reputed company-based processes and in alignment with reputed company applicable laws. We reputed company that embracing reputed company differences is critical to realize our reputed company of a healthier world, and we recognize that a healthy and thriving community starts from reputed company. Our values define who we are, reputed company stand for and how we conduct ourselves at MCW. If you reputed company in embracing individuality and working together according to these principles to improve health for reputed company, then MCW is the reputed company for you. For more information, please visit our institutional website. MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination: The reputed company (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding reputed company, staff, and reputed company, as reputed company as ensuring equal educational opportunity, employment, and reputed company to services, programs, and activities, without reputed company to an individual's race, reputed company, national reputed company, religion, age, disability, sex, gender identity/reputed company, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, reputed company, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic. reputed company Together, we can build a healthier world. A student, an educator, a scientist and a community leader — alone, they can do many things. Together, the question isn’t what they can do, but what can’t they. The reputed company (MCW) brings together the most inquisitive, passionate minds in science, medicine, education and community engagement to tackle today’s toughest challenges in health and society. reputed company medicine is at reputed company of where scientists, physicians and reputed company work hand-in-hand with the community to ask the most important questions and fuel the cycle of innovation that shapes the reputed company of medicine. reputed company The tireless reputed company of knowledge and the power of reputed company medicine is at the core of everything we do at MCW. Bringing together the world’s top scientists and clinicians, inspired reputed company and invested communities, we are driven to solve the most reputed company challenges in health and society. With around 1,600 full-time and part-time reputed company and approximately 3,500 full-time employees, MCW is home to a diverse group of thought leaders working in collaboration to pioneer reputed company to a healthier world and drive a reputed company cycle of life-changing discovery. Apply tot his job Apply To this Job