Regulatory Services Manager – National Center for Clinical Trials

Job not on LinkedIn

🔥 13 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $44 - $66 / hour

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Advocate Aurora Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

💰 $10.2M Grant on 2019-08

Healthcare • Healthcare Insurance

Advocate Aurora Health is a leading healthcare organization that operates across various regions including Central Chicagoland, Central Wisconsin, Greater Milwaukee, and more. With a diverse range of career areas such as advanced practice clinicians, behavioral health, nursing, and more, Advocate Aurora Health is committed to helping people live well. The organization offers numerous benefits and opportunities for career advancement, fostering an environment where individuals can thrive and innovate in the healthcare sector. Advocate Aurora Health prioritizes the safety of its candidates and maintains a robust recruitment process to protect sensitive information.

📋 Description

• Provides overall administrative direction and coordination of Regulatory Services for NCCT clinical research • Ensures compliance with institutional, IRB, federal and other applicable regulatory requirements across clinical trials • Supervises and guides staff regarding IRB submissions, HIPAA compliance and regulatory communications • Develops, implements and enforces policies, procedures and tools supporting compliant and efficient research operations • Leads hiring, training, performance management, coaching and professional development for regulatory staff • Oversees initial and continuing IRB reviews, amendments, reportable events and study closures • Monitors regulatory documentation and timely completion of submissions and approvals • Ensures compliance with GCP, ICH, FDA, OHRP, HIPAA, state and federal regulations, institutional policies and departmental SOPs • Prepares for, manages and responds to audits and inspections • Leads responses to audit findings and coordinates CAPA plans • Oversees regulatory projects and workflows, monitoring timelines, deliverables, risks and barriers • Allocates regulatory staff resources across study portfolios and departmental priorities • Communicates regulatory status, risks and compliance issues to investigators, study teams and leadership • Monitors regulatory changes and leads related process or policy changes • Supports protocol development, study start-up and close-out activities • Maintains relationships with stakeholders, sponsors, IRB and regulatory agencies • Coordinates regulatory metrics, reports and compliance analyses • Participates in research compliance and regulatory affairs meetings and committees • Assists leadership with regulatory policies and quality initiatives • Manages special regulatory projects and performs related duties

🎯 Requirements

• 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 • Excellent verbal and written communication skills • Knowledge of scientific and statistical principles • Ability to travel to affiliate sites, clinical sites and national meetings • Familiarity with institutional/governmental regulations and guidelines related to clinical research • Knowledge of the elements of Good Clinical Practices • Ability to work Monday through Friday, 8 AM - 4:30 PM

🏖️ Benefits

• Benefits Eligible • 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 • Competitive compensation • Programs that invest in career development • Opportunity for annual increases based on performance • Incentive pay for select positions • Premium pay such as shift, on call, and more based on a teammate's job