Research Regulatory Specialist

Department
85190 Greater Charlotte Research and Other Sponsored Programs - Academic Internal Medicine

Status
Full time

Benefits Eligible
Yes

Hours Per Week
40

Schedule Details/Additional Information
M-F, 8am-430pm

Pay Range
$ $45.25

This role is both grant and department funded.

Major Responsibilities

• Supports multiple complex clinical research studies, which may involve multi-centered, cooperative group studies, single site studies, intergroup studies, industry studies, and investigator-initiated 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 the Research Business Services Office 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.
• Participates in the development and implementation of quality improvement and quality assurance activities. Other duties as assigned.

Licensure, Registration, And/or Certification Required

• None Required.

Education Required

• Bachelor's Degree (or equivalent knowledge) in Business or related field.
• Bachelor's Degree (or equivalent knowledge) in Health Care Administration or related field.

Experience Required

• Typically requires 3 years of experience in research, clinical trials research and regulatory knowledge.
• Clinical Research Coordinator Experience a plus, ACRP (CCRC),SOCRA (CCRP), or Regulatory Affairs Certification (RAC) a plus. Workday, Concur, RedCap, Florence, and OnCore a plus.

Knowledge, Skills & Abilities Required

• 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
• Ability to travel between facilities as needed.

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 CommitmenttoYou
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, andShort- 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

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. This position will be M-F, 8am-430pm