Regulatory Services Manager - NCCT (Remote)
Atrium Health Wake Forest Baptist
Milwaukee, WI
Others
Department
85296 Wake Forest University Health Sciences - Clinical Trial Methods Center of Excellence
Status
Full time
Benefits Eligible
Yes
Hours Per Week
40
Schedule Details/Additional Information
Pay Range
$44.15 - $66.25
EDUCATION/EXPERIENCE: Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or, an equivalent combination of education and experience. Experience in medical/research environment preferred. LICENSURE, CERTIFICATION, and/or REGISTRATION: N/A ESSENTIAL FUNCTIONS: 1. Provides administrative direction and coordination in the formulation, interpretation and administration of current and long range policies, procedures, and programs across all clinical sites. Provides guidance and advice in the completion of initial and annual IRB approvals. Monitors the completion and approval of all IRB requests. 2. Ensures that all aspects of all studies are conducted in accordance to the applicable protocol and contract. Ensures that all HIPAA regulations, compliance and regulatory requirements are met. Acquires timely information regarding HIPAA privacy and security guidelines. Analyzes and determines the effect on the clinic activities and implement changes to maintain compliance with HIPAA and all other regulations, such as FDA, HHS, NIH, and OSHA. Participate in audits of cooperative groups and affiliates. 3. Manages a large clinical research staff including hiring, performance evaluations, merit recommendations, promotions, transfers, and schedules. 4. Monitors clinical functions and participant flow management. Develops procedures to ensure participant satisfaction and to maintain consistency throughout all clinics. 5. Directs the development of computerized methods for monitoring and reporting on research activities as well as the analysis of data. Assists principal investigators and project managers in developing progress reports and quality control monitoring. 6. Assists in protocol development activities, study operations, and closing of studies. Provides guidance to principal investigators in transitioning staff as funding begins/ends. 7. Establishes working relations with other departments and organizations and assists in integration of studies when appropriate. Facilitates and develops relationships with NIH, FDA, etc. 8. Provides guidance and oversight in determining how personnel, space, and equipment may be utilized across studies to improve efficiency. Plans and coordinates construction, renovation and maintenance activities within or related to the clinic. 9. Ensures that all requirements of the Medical School and the University comply to the conduct of the clinical research. Ensures that all technical requirements of the funding agency are met, including auditing requirements. 10. Coordinates and prepares operational reports and analyses setting forth progress, adverse trends and appropriate recommendations. 11. Participates and supports internal and external meetings and committees. 12. Assists in implementing institutional and departmental policies. 13. Manages special projects and other initiatives as assigned. 14. Performs other related duties incidental to work described herein. SKILLS/QUALIFICATIONS: Excellent verbal and written communication skills Demonstrates knowledge of scientific and statistical principles Ability to travel to affiliate sites, clinical sites and national meetings Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices WORK ENVIRONMENT: Clean, well lit, office environment PHYSICAL REQUIREMENTS: Amount of time spent performing the following activities: 0% 35% 65% to to to 35% 65% 100% N/A Activity X Standing X Walking X Sitting X Bending X Reaching with arms X Finger and hand dexterity X Talking X Hearing X Seeing Lifting, carrying, pushing and or pulling: X 20 lbs. maximum X 50 lbs. maximum X 100 lbs. maximum
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
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.
Under administrative review, provides overall administrative direction and coordination for policies, procedures, and programs for a large number of research studies and/or clinical trials. Supervises and provides expertise and guidance to staff regarding IRB submissions, communication, and implementation of HIPAA regulations, compliance and other regulatory issues. Requires the use of judgment and discretion in performing the assigned duties and responsibilities.
85296 Wake Forest University Health Sciences - Clinical Trial Methods Center of Excellence
Status
Full time
Benefits Eligible
Yes
Hours Per Week
40
Schedule Details/Additional Information
Pay Range
$44.15 - $66.25
EDUCATION/EXPERIENCE: Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or, an equivalent combination of education and experience. Experience in medical/research environment preferred. LICENSURE, CERTIFICATION, and/or REGISTRATION: N/A ESSENTIAL FUNCTIONS: 1. Provides administrative direction and coordination in the formulation, interpretation and administration of current and long range policies, procedures, and programs across all clinical sites. Provides guidance and advice in the completion of initial and annual IRB approvals. Monitors the completion and approval of all IRB requests. 2. Ensures that all aspects of all studies are conducted in accordance to the applicable protocol and contract. Ensures that all HIPAA regulations, compliance and regulatory requirements are met. Acquires timely information regarding HIPAA privacy and security guidelines. Analyzes and determines the effect on the clinic activities and implement changes to maintain compliance with HIPAA and all other regulations, such as FDA, HHS, NIH, and OSHA. Participate in audits of cooperative groups and affiliates. 3. Manages a large clinical research staff including hiring, performance evaluations, merit recommendations, promotions, transfers, and schedules. 4. Monitors clinical functions and participant flow management. Develops procedures to ensure participant satisfaction and to maintain consistency throughout all clinics. 5. Directs the development of computerized methods for monitoring and reporting on research activities as well as the analysis of data. Assists principal investigators and project managers in developing progress reports and quality control monitoring. 6. Assists in protocol development activities, study operations, and closing of studies. Provides guidance to principal investigators in transitioning staff as funding begins/ends. 7. Establishes working relations with other departments and organizations and assists in integration of studies when appropriate. Facilitates and develops relationships with NIH, FDA, etc. 8. Provides guidance and oversight in determining how personnel, space, and equipment may be utilized across studies to improve efficiency. Plans and coordinates construction, renovation and maintenance activities within or related to the clinic. 9. Ensures that all requirements of the Medical School and the University comply to the conduct of the clinical research. Ensures that all technical requirements of the funding agency are met, including auditing requirements. 10. Coordinates and prepares operational reports and analyses setting forth progress, adverse trends and appropriate recommendations. 11. Participates and supports internal and external meetings and committees. 12. Assists in implementing institutional and departmental policies. 13. Manages special projects and other initiatives as assigned. 14. Performs other related duties incidental to work described herein. SKILLS/QUALIFICATIONS: Excellent verbal and written communication skills Demonstrates knowledge of scientific and statistical principles Ability to travel to affiliate sites, clinical sites and national meetings Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices WORK ENVIRONMENT: Clean, well lit, office environment PHYSICAL REQUIREMENTS: Amount of time spent performing the following activities: 0% 35% 65% to to to 35% 65% 100% N/A Activity X Standing X Walking X Sitting X Bending X Reaching with arms X Finger and hand dexterity X Talking X Hearing X Seeing Lifting, carrying, pushing and or pulling: X 20 lbs. maximum X 50 lbs. maximum X 100 lbs. maximum
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
- 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
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.
Under administrative review, provides overall administrative direction and coordination for policies, procedures, and programs for a large number of research studies and/or clinical trials. Supervises and provides expertise and guidance to staff regarding IRB submissions, communication, and implementation of HIPAA regulations, compliance and other regulatory issues. Requires the use of judgment and discretion in performing the assigned duties and responsibilities.
About the company
Company website•Hospitals and Health Care
Atrium Health Wake Forest Baptist is a nationally recognized academic medical center and health system based in Winston-Salem, NC, part of Advocate Health, the third-largest nonprofit health system in the United States.
Atrium Health Wake Forest Baptist’s two main components are an integrated clinical system – anchored by Atrium Health Wake Forest Baptist Medical Center, 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; and Wake Forest University School of Medicine, a recognized leader in experiential medical education and groundbreaking research. Atrium Health Wake Forest Baptist and Wake Forest University School of Medicine are the academic core of Advocate Health. Atrium Health Wake Forest Baptist employs more than 20,000 teammates, part of Advocate Health’s 150,000 teammates.
Atrium Health Wake Forest Baptist provided a record-setting $611.2 million in community benefits during the 2021 fiscal year, which includes unreimbursed care, charity care, education and research, and community health improvement.