Research Regulatory Specialist

• National Center for Clinical Trials (NCCT) Atrium Health
• 3.7 Winston-Salem, NC Job Details Full-time $30.70
• $46.

05 an hour 9 hours ago Benefits Paid parental leave Disability insurance Health insurance Dental insurance Flexible spending account Tuition reimbursement Paid time off Adoption assistance Parental leave Vision insurance Retirement plan Qualifications FDA submissions Version control Incident reporting compliance Microsoft Excel Adverse event reporting Clinical incident reports Healthcare Administration Bachelor's degree in business Filing Mid-level 3 years ICH guidelines Bachelor's degree Clinical data entry Team training Quality improvement Microsoft Teams Clinical trial standard operating procedures Research administration Clinical trial patient safety management Bachelor's degree in healthcare administration Regulatory submission editing and review Communication with regulatory authorities for clinical trials Clinical research inspection readiness Business Administration Productivity software Clinical quality assurance standards Business Ethical review application preparation Standard operating procedures (SOPs)

Full Job Description Department:

10010 NCCT (National Center for Clinical Trials)•

Administration Status:

Full time

Benefits Eligible:

Yes Hou rs

Per Week:

40

Schedule Details/Additional Information:

Monday

• Friday 8 AM
• 4:30 PM.

Remote position.

Pay Range:

$30.70

• $46.

05 ABOUT NCCT The National Center for Clinical Trials (NCCT) is designed to serve as an innovative platform to revolutionize and catalyze the conduct of clinical trials 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 core services for patient recruitment and enrollment, trial administration and follow-up, and to gather real world data and evidence.

JOB SUMMARY

This position will be part of a team that will report to leadership in the NCCT and provides direct regulatory support for NCCT studies. Responsibilities include the preparation, review and submission of required regulatory documents to the Institutional Review Board (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 timely submission of regulatory documents for new and ongoing studies. Contributes to the development of Standard Operating Procedures (SOPs) and compliance policies in clinical research related to regulatory submissions. Promotes the ethical conduct of research.

EDUCATION/EXPERIENCE

Bachelor's Degree (or equivalent knowledge) in Business or related field. Bachelor's Degree (or equivalent knowledge) in Health Care Administration or related field. Typically requires 3 years of experience in research, clinical trials research and regulatory knowledge.

ESSENTIAL FUNCTIONS

Supports multiple complex clinical research studies, which may involve multi-site studies, single site studies, industry studies, investigator-initiated studies and real world data and evidence studies. Plans, develops and prepares all required regulatory documents, including all initial, amendments and continuing reviews to the IRB, FDA, Office for Human 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 resolve questions or issues regarding regulatory submissions and ensure timely review and approval in compliance with local and external IRB SOPs and other regulatory agency requirements. Collaborates with various internal stakeholders to assist with initial study submission, amendments and close out. Collaborates with study team to ensure implementation of amendments, awareness of safety and protocol changes, and version control management. Acts as a liaison to investigators and research coordinators for reporting Adverse Events, noncompliance, and other FDA required reporting events. Maintains study level documentation for all studies, including those that are complex in nature. Ensure files are audit ready. 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 complex, highly specialized regulations and guidance associated with clinical research studies and trials involving human subjects. Attends and participates in educational programs, meetings and assigned committees. Participates in the development and implementation of quality improvement and quality assurance activities. Other duties as assigned.

SKILLS/QUALIFICATIONS

Knowledge of FDA and DHHS regulations and ICH GCP guidelines, Human Subject Protection rules and regulations related to regulatory documents. Knowledge of policies, procedures and SOPs specifically related to regulatory documents. Knowledge of clinical trials 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, Microsoft Office, Word, Excel, Adobe, and Teams. Physical Requirements and Working Conditions Must be able to sit, stand, walk, lift, squat, bend, reach 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 job description indicates the general nature 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 perform other related duties. Our Commitment to

You:

Advocate Health offers a comprehensive suite of

Total Rewards:

benefits and well-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 Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, vision, 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 paid 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, per diem, temporary, etc.); please ask a Recruiter for more information during an interview. About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health 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 equitable care for all, Advocate Health provides more than $6 billion in annual community benefits. Responsible for the preparation, review and submission of required regulatory documents to the Institutional Review Board (IRB), Food and Drug Administration (FDA), and other regulatory bodies, including central offices of cooperative group studies. Coordinates and interfaces between the regulatory bodies, industry representatives and the AARI team members. Responsible for supporting the clinical research activity and research staff through timely submission of regulatory documents for new and ongoing studies. Contributes to the development of Standard Operating Procedures (SOPs) and compliance policies in clinical research related to regulatory submissions. Promotes the ethical conduct of research.