NCCT Research Regulatory Specialist, Sr. - Remote

NCCT Research Regulatory Specialist, Sr. - Remote

JOB DESCRIPTION

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 for new and ongoing studies. 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 5 years of experience in research, clinical trials research and regulatory knowledge. Previous experience interacting with the FDA and other regulatory bodies.

LICENSURE, REGISTRATION AND/OR CERTIFICATION REQUIRED

• Clinical Research Coordinator (CCRC) certification issued by the Association of Clinical Research Professionals (ACRP) when eligible needs to be obtained within 1 year, or
• IRB Professional (CIP) certification issued by the Council for Certification of IRB Professionals (CCIP) when eligible needs to be obtained within 1 year, or
• Regulatory Affairs (RAC) certification issued by the Regulatory Affairs Professionals Society (RAPS) needs to be obtained within 1 year, or
• Clinical Research Professional (CCRP) certification issued by the Society of Clinical Research Associates (SOCRA) needs to be obtained within 1 year, or
• ACRP Certified Professional (ACRP-CP) certification issued by the Associate of Clinical Research Professionals (ACRP).

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 closeout.
• 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.
• Provides recommendations to proactively address complex regulatory issues, process improvements, and or/variances with study protocols.
• Trains and mentors Regulatory Specialists. Leads and provides guidance in the development and implementation of quality improvement and quality assurance activities.
• Maintains current knowledge of industry trends. Manages special projects. Other duties as assigned.

SKILLS/QUALIFICATIONS

• Extensive knowledge of FDA and DHHS regulations and ICH GCP guidelines, Human Subject Protection rules and regulations related to regulatory documents. Familiarity with relevant ISO guidelines.
• Knowledge of policies, procedures and SOPs specifically related to regulatory processes and documentation.
• 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.

About Us

Wake Forest University School of Medicine (WFUSM) is a U.S. News and World Report top 50 ranked medical school, integrated with a world-class health system,Atrium Health. WFUSM, the academic core of Atrium Health Enterprise, is a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery. WFUSM, has over $300M in annual, extramural funding that drives a cutting-edge Academic Learning Health System by integrating innovative research with excellent patient care across our enterprise.

Atrium Health is based in Winston-Salem, North Carolina and is part of Advocate Health, which is headquartered in Charlotte, North Carolina, and is the fifth-largest nonprofit health system in the United States, created from the combination of Atrium Health and Advocate Aurora Health. AHWFB is an 885-bed tertiary-care hospital in Winston-Salem – that includes Brenner Children's Hospital, five community hospitals, more than 300 primary and specialty care locations and more than 2,700 physicians.

Our highly integrated academic and clinical environment is deeply committed to improving health, elevating hope, and advancing healing – for all.

It should be noted that while you are applying on the Wake Forest University School of Medicine Career Site, you will receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process. Thanks in advance for your flexibility.

Pay Range

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