Regulatory Services Manager NCCT (Remote)

Pay Range

Education Experience and Certifications

Masters 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

JOB SUMMARY
The Advocate Health National Center for Clinical Trials (NCCT) serves as an innovative platform to accelerate the conduct of clinical trials and the translation of scientific discoveries into meaningful improvements in patient care. NCCT provides centralized services for patient recruitment and enrollment trial administration and follow-up and the generation of real-world data and evidence.

Under administrative review provides overall administrative direction and coordination of Regulatory Services for NCCT clinical research ensuring compliance with institutional IRB federal and other applicable regulatory requirements across a large number of clinical trials. Supervises and provides expertise and guidance to staff regarding IRB submissions HIPAA compliance and regulatory communications. Develops implements and enforces policies procedures and tools to support compliant and efficient research operations. Requires the use of judgment and discretion in performing the assigned duties and responsibilities.

FUNCTIONS

• Provides administrative oversight and direct leadership to regulatory staff including hiring training performance management coaching and professional development; supports remote training and ongoing regulatory education.
• Oversees regulatory submissions and approvals including initial and continuing IRB reviews amendments reportable events and study closures; monitors timely completion and maintenance of regulatory documentation.
• Ensures all regulatory activities are conducted in compliance with applicable regulations and standards including GCP ICH FDA OHRP HIPAA state and federal regulations institutional policies and departmental SOPs.
• Prepares for manages and responds to internal and external audits and inspections; leads responses to audit findings and coordinates development implementation and tracking of corrective and preventive action (CAPA) plans.
• Provides oversight of multiple regulatory projects and workflows monitoring progress against timelines and deliverables and addressing risks or barriers.
• Allocates regulatory staff resources appropriately to support study portfolios and departmental priorities.
• Communicates regulatory status risks and potential compliance issues to investigators study teams and leadership; escalates concerns as appropriate.
• Monitors regulatory changes and guidance (e.g. FDA NIH HHS HIPAA) and evaluates impact on clinical research operations; leads implementation of process or policy changes to maintain compliance.
• Supports protocol development and study startup and closeout activities by advising on regulatory feasibility documentation requirements and transitions as funding or study status changes.
• Establishes and maintains effective working relationships with institutional stakeholders sponsors IRB and regulatory agencies to support compliant research conduct.
• Coordinates preparation of regulatory metrics reports and compliance analyses identifying trends risks and opportunities for process improvement.
• Participates in departmental institutional and external meetings or committees related to research compliance and regulatory affairs.
• Assists leadership in implementing institutional and departmental regulatory policies and quality initiatives.
• Manages special regulatory projects and performs other related duties as assigned.

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 teammates 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

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.