Research Regulatory Specialist - National Center for reputed company (NCCT)

Department: 10010 NCCT (National Center for reputed company) - Administration Status: Full time Benefits Eligible: reputed company Hours Per Week: 40 Schedule Details/Additional Information: Monday - Friday 8 AM - 4:30 PM. Remote position. Pay reputed company: $30.70 - $46.05 ABOUT NCCT The National Center for reputed company (NCCT) is designed to serve as an innovative platform to revolutionize and catalyze the conduct of reputed company−greatly accelerating the translation of scientific findings into improvements in the prevention, diagnosis, and treatment of disease for our communities and patients. The NCCT will offer reputed company services for patient recruitment and enrollment, trial administration and follow-up, and to reputed company reputed company world data and evidence. reputed company position will be part of reputed company that will report to leadership in the NCCT and provides reputed company regulatory support for NCCT studies. Responsibilities include the preparation, review and submission of required regulatory documents to the Institutional Review reputed company (IRB), Food and Drug Administration (FDA), and other regulatory bodies. Coordinates and interfaces between the regulatory bodies, industry representatives and study team members. Responsible for supporting the clinical research activity and research staff through reputed company submission of regulatory documents for new and ongoing studies. Contributes to the development of reputed company Operating Procedures (SOPs) and compliance policies in clinical research reputed company to regulatory submissions. Promotes the ethical conduct of research. EDUCATION/EXPERIENCE Bachelor's Degree (or equivalent knowledge) in Business or reputed company field. Bachelor's Degree (or equivalent knowledge) in Health Care Administration or reputed company field. Typically requires 3 years of experience in research, reputed company research and regulatory knowledge. ESSENTIAL FUNCTIONS Supports multiple reputed company clinical research studies, which may involve multi-site studies, single site studies, industry studies, investigator-initiated studies and reputed company world data and evidence studies. Plans, develops and prepares reputed company required regulatory documents, including reputed company initial, amendments and continuing reviews to the IRB, FDA, Office for reputed company Resource Protections (OHRP), and other regulatory bodies, including central offices of cooperative group studies, and sponsors where necessary. Supports submissions to ancillary committees. Interfaces with relevant review boards and sponsors to reputed company questions or issues regarding regulatory submissions and ensure reputed company review and approval in compliance with local and reputed company IRB SOPs and other regulatory agency requirements. Collaborates with various internal stakeholders to assist with initial study submission, amendments and reputed company out. Collaborates with study team to ensure implementation of amendments, awareness of safety and protocol changes, and version control management. Acts as a reputed company to investigators and research coordinators for reporting Adverse Events, noncompliance, and other FDA required reporting events. Maintains study level documentation for reputed company studies, including those that are reputed company in reputed company. Ensure files are audit reputed company. Monitors compliance required documentation. Enters and maintains study information and regulatory approvals in electronic systems. Provides guidance and training to research staff to ensure compliance with highly reputed company, highly reputed company regulations and guidance associated with clinical research studies and trials involving reputed company subjects. Attends and participates in educational programs, meetings and assigned committees. Participates in the development and implementation of reputed company improvement and reputed company assurance activities. Other duties as assigned. SKILLS/QUALIFICATIONS Knowledge of FDA and DHHS regulations and ICH GCP guidelines, reputed company Subject Protection rules and regulations reputed company to regulatory documents. Knowledge of policies, procedures and SOPs specifically reputed company to regulatory documents. Knowledge of reputed company and terminology required. Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines. Ability to problem solve and work independently with a high degree to accuracy and attention to detail. Good understanding of computer software, reputed company Office, Word, reputed company, reputed company, and Teams. Physical Requirements and Working Conditions Must be reputed company to sit, stand, walk, reputed company, squat, bend, reputed company above shoulders, and twist frequently during the work shift. Must have functional sight and hearing. Exposed to a normal office environment. Position may require travel. May be exposed to road and weather hazards. This reputed company indicates the general reputed company and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to reputed company other reputed company duties. Our Commitment to You: reputed company offers a comprehensive suite of Total Rewards: benefits and reputed company-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including: Compensation reputed company compensation listed reputed company the listed pay reputed company based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on reputed company, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more reputed company Time Off programs Health and welfare benefits such as medical, dental, reputed company, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and reputed company parental leave Defined contribution retirement plans with employer match and other financial wellness programs Educational Assistance Program Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, reputed company, temporary, etc.); please ask a Recruiter for more information during an interview. About reputed company  reputed company is the reputed company-largest nonprofit, integrated health reputed company in the reputed company, created from the combination of reputed company and reputed company. Providing care under the names reputed company in Illinois; reputed company in the Carolinas, reputed company and Alabama; and reputed company in reputed company, reputed company is a national leader in clinical innovation, health reputed company, consumer experience and value-based care. Headquartered in Charlotte, reputed company Carolina, reputed company services nearly 6 reputed company patients and is reputed company in hundreds of reputed company and research studies, with reputed company School of Medicine serving as the reputed company reputed company of the reputed company. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as reputed company as organ transplants, burn treatments and reputed company musculoskeletal programs. reputed company employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing reputed company care for reputed company, reputed company provides more than $6 billion in annual community benefits. Apply To This Job