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Research manager Jobs in Winston-Salem, NC

Last updated: 13 hours ago
  • Promoted
Manager, Research Regulatory Programs, Gerontology

Manager, Research Regulatory Programs, Gerontology

Wake Forest University School of MedicineWinston-Salem, NC, United States
Full-time
Manager, Research Regulatory Programs.This role ensures adherence to Institutional Review Board (IRB) requirements, FDA regulations, and HIPAA compliance while offering expert guidance to principal...Show moreLast updated: 2 days ago
  • Promoted
Research Consultant-Research Team-Medical & Scientific Solutions

Research Consultant-Research Team-Medical & Scientific Solutions

Womble Bond Dickinson (US) LLPWinston-Salem, NC, United States
Full-time
Womble Bond Dickinson (US) LLC is currently seeking a Research Consultant for the Medical & Scientific Solutions Team which will be responsible for conducting high level research on medical and sci...Show moreLast updated: 30+ days ago
  • Promoted
Research Associate, Physics

Research Associate, Physics

InsideHigherEdWinston Salem, North Carolina
Part-time
Your application will automatically populate your resume details, and you may verify and update data on the.Resume / CV document upload section at the bottom of the. You will not be able to modify you...Show moreLast updated: 4 days ago
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CLINICAL RESEARCH NURSE COORDINATOR

CLINICAL RESEARCH NURSE COORDINATOR

Duke UniversityNC, United States
Full-time
Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools.Ranked sixth among medical schools in the nation, the School takes pride in being an incl...Show moreLast updated: 2 days ago
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Academic / Faculty / Research Physician - Competitive Salary

Academic / Faculty / Research Physician - Competitive Salary

DocCafeNC, United States
Full-time
DocCafe has an immediate opening for the following position : Physician - Academic / Faculty / Research in North Carolina. DocCafe is the premier physician and advanced practice job board to help you adv...Show moreLast updated: 3 days ago
Senior Research Scientist- remote

Senior Research Scientist- remote

Thermo Fisher ScientificNorth Carolina, United States of America
Remote
Full-time
The SRS bears responsibility for scientific strategy for RWE, medical affairs, and certain clinical studies, including the leading of the overall research strategy development for proposals, the de...Show moreLast updated: 30+ days ago
  • Promoted
Earn Rewards for Your Opinions – Consumer Product Surveys! - Work from Home Flexibility (Hiring Immediately)

Earn Rewards for Your Opinions – Consumer Product Surveys! - Work from Home Flexibility (Hiring Immediately)

Maxion ResearchWinston-Salem, North Carolina, US
Remote
Part-time
Join Our Part-Time Research Studies Today!.Are you eager to earn extra income from the comfort of your home? We are looking for motivated individuals to participate in paid research studies includi...Show moreLast updated: 1 day ago
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Research Associate, Physics

Research Associate, Physics

Wake Forest UniversityWinston Salem, NC, United States
Your application will automatically populate your resume details, and you may verify and update data on the.Resume / CV document upload section at the bottom of the. You will not be able to modify you...Show moreLast updated: 30+ days ago
  • Promoted
Research Scholar, Cardiology-Adult

Research Scholar, Cardiology-Adult

Atrium HealthWinston-Salem, NC, United States
Full-time
The ideal candidate will have a B.PhD in statistics, computer science, or applied mathematics with excellent computational skills in Python. Previous experience with both machine and deep learning i...Show moreLast updated: 30+ days ago
Senior Field Sales Manager - Research & Learning - SaaS •Remote •

Senior Field Sales Manager - Research & Learning - SaaS •Remote •

CCH IncorporatedRemote, NC, USA
Remote
Full-time
Wolters Kluwer Tax & Accounting North America.Research and Learning, US (CCHGroup.Wolters Kluwer Tax & Accounting, one of the world's leading providers of tax, accounting and audit information, sol...Show moreLast updated: 30+ days ago
VP, Research & Development

VP, Research & Development

Caretracker, Inc.North Carolina, United States
Remote
Full-time
We are looking for a high-performing Vice President of Research & Development to join us at the Harris Ambulatory Care Enterprise, a division of Harris Computer. This person will head R&D for the Am...Show moreLast updated: 30+ days ago
Healthcare Research Systems Programmer / Analyst

Healthcare Research Systems Programmer / Analyst

RTI InternationalAny RTI Office, North Carolina, United States
$126,000.00–$156,000.00 yearly
Full-time
RTI International (RTI) is both a global research institute and a leading international development organization based out of North Carolina. At RTI, you will find work you believe in, tackling some...Show moreLast updated: 30+ days ago
Senior UX Research Operations Manager

Senior UX Research Operations Manager

ALTERYXNorth Carolina, USA, Remote
$112,000.00–$143,000.00 yearly
Remote
Full-time
We’re looking for problem solvers, innovators, and dreamers who are searching for anything but business as usual.Like us, you’re a high performer who’s an expert at your craft, constantly challengi...Show moreLast updated: 30+ days ago
  • Promoted
NURSING (RN) SUPERVISOR - HEMATOLOGY / ONCOLOGY RESEARCH

NURSING (RN) SUPERVISOR - HEMATOLOGY / ONCOLOGY RESEARCH

ECU Health IntegrationNC, United States
Full-time
If the following job requirements and experience match your skills, please ensure you apply promptly.ECU Health is a mission-driven, 1,708-bed academic health care system serving more than 1.The no...Show moreLast updated: 2 days ago
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  • New!
Research Physicist

Research Physicist

OutlierWinston-Salem, NC
$30.00–$50.00 hourly
Full-time
Outlier helps the world’s most innovative companies improve their AI models by providing human feedback.Are you an experienced physics who would like to lend your expertise to train AI models?.Outl...Show moreLast updated: 13 hours ago
  • Promoted
Paid Research Participant- No Experience Needed

Paid Research Participant- No Experience Needed

IncomeFindrWINSTON SALEM, NC, United States
Full-time
Position Overview : This role offers a flexible work-from-home arrangement, enabling you to engage in various activities such as online surveys, focus groups, clinical trials, product tests, and opti...Show moreLast updated: 22 days ago
Senior Vice President, Research & Development

Senior Vice President, Research & Development

Fairway Consulting GroupNorth Carolina
Our client is a biotechnology company.They have asked us to assist them in a search for a.Senior Vice President, Research & Development. Major tasks and responsibilities include : .Oversees the Techno...Show moreLast updated: 30+ days ago
Research and Development Engineer 1

Research and Development Engineer 1

Cook MedicalSalem NC United States, Winston
Full-time
The primary purpose of the Research and Development Engineer at Cook Winston-Salem is to design, test and technically document the feasibility, construction and production process of new and / or cha...Show moreLast updated: 30+ days ago
Manager, Research Regulatory Programs, Gerontology

Manager, Research Regulatory Programs, Gerontology

Wake Forest University School of MedicineWinston-Salem, NC, United States
2 days ago
Job type
  • Full-time
Job description

Job Description

JOB SUMMARY

The Manager, Research Regulatory Programs provides strategic oversight and coordination of regulatory compliance, policies, and programs across multiple research studies and clinical trials. This role ensures adherence to Institutional Review Board (IRB) requirements, FDA regulations, and HIPAA compliance while offering expert guidance to principal investigators (PIs) and research staff. As a supervisor, the Senior Regulatory Specialist leads regulatory efforts, mentors junior staff, and plays a critical role in regulatory submissions and FDA-related activities, including investigational new drug (IND) and investigational device exemption (IDE) applications. The position requires sound judgment and discretion, functioning with minimal supervision to support research objectives.

EDUCATION / EXPERIENCE

Required :

  • Bachelor's degree in a relevant field (e.g., Health Administration, Nursing, Psychology, Biological Sciences, or a related discipline).
  • Minimum of five (5) years of experience in regulatory affairs within clinical research, with a focus on FDA-regulated studies.

Preferred :

  • Master's degree in a related discipline.
  • Experience in an academic medical research environment , preferably within hospital or medical school settings.

    • LICENSURE / CERTIFICATION

  • Certification from the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP) is preferred.

    • ESSENTIAL FUNCTIONS

    1. Regulatory Oversight & Compliance :

  • Serve as the departmental subject matter expert (SME) , providing advanced regulatory guidance to ensure compliance with IRB standard operating procedures (SOPs), HIPAA regulations, and federal regulatory requirements (e.g., FDA, NIH, HHS, OSHA ).
  • Oversee the preparation, submission, and maintenance of regulatory documents, including IRB applications, FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications , amendments, and continuing reviews.
  • Ensure adherence to Good Clinical Practices (GCP), International Council for Harmonisation (ICH) guidelines, and FDA submission standards , maintaining an audit-ready state for all studies.
  • Advise investigators and study teams on regulatory pathways, assisting with pre-IND and pre-IDE meetings and correspondence with regulatory agencies.

    • 2. Supervisory & Leadership Responsibilities :

  • Provide direct supervision and mentorship to regulatory team members, ensuring adherence to policies and procedures while fostering professional growth.
  • Manage team performance, including conducting evaluations, providing feedback, and developing staff training plans to improve regulatory competency.
  • Oversee recruitment, onboarding, and performance management of regulatory personnel to ensure optimal department functioning.
  • Assign tasks and allocate resources efficiently to meet departmental goals and study deadlines.

    • 3. Audit Readiness & Quality Assurance :

  • Lead the preparation and coordination of FDA audits, sponsor inspections, and internal / external regulatory audits , ensuring adherence to compliance standards.
  • Develop and implement risk assessment strategies and quality assurance initiatives to proactively address potential compliance gaps.
  • Maintain complete and accurate regulatory documentation, including SOPs, informed consent forms, and study logs to meet FDA and institutional requirements.

    • 4. Clinical Operations & Study Management :

  • Collaborate with PIs, project managers, and clinical teams to ensure trials comply with protocol specifications and regulatory commitments.
  • Establish workflows for data collection, reporting, and regulatory submissions to align with sponsor expectations and FDA requirements.
  • Provide operational oversight for study initiation, conduct, and close-out, ensuring proper documentation and regulatory compliance.

    • 5. FDA Submission & Reporting :

  • Oversee the preparation and submission of FDA-related documents, including :

    • IND / IDE applications

  • Annual progress reports
  • Safety reports and adverse event submissions (SAEs, SUSARs)
  • Clinical trial registration and results reporting to ClinicalTrials.gov
  • Collaborate with biostatistics and clinical teams to ensure compliance with FDA data requirements and submission timelines.

    • 6. Training & Staff Development :

  • Develop and conduct comprehensive training programs for research staff on FDA regulations, IRB requirements, and best practices in regulatory compliance.
  • Provide ongoing education on regulatory changes, ensuring the department remains up to date with evolving FDA guidelines and industry standards.
  • Mentor junior regulatory staff, providing guidance on complex submissions and regulatory pathways.

    • 7. Stakeholder & Sponsor Relations :

  • Establish and maintain strong working relationships with sponsors, regulatory agencies, and affiliate organizations to facilitate study operations and compliance.
  • Represent the department at sponsor meetings, national conferences, and regulatory working groups to advocate for best practices and regulatory excellence.

    • 8. Operational Leadership & Special Projects :

  • Contribute to the development and execution of long-term strategic initiatives to enhance regulatory efficiency and compliance.
  • Prepare operational reports and analyses, identifying trends, challenges, and solutions for regulatory process improvements.
  • Participate in internal and external committees to support institutional objectives and regulatory innovation.

    • SKILLS / QUALIFICATIONS

  • Extensive knowledge of clinical research methodologies, FDA regulations, and human subject protection standards.
  • Strong leadership and team management abilities, with a demonstrated ability to supervise and mentor staff effectively.
  • Excellent verbal and written communication skills, with the ability to convey complex regulatory concepts to diverse audiences.
  • Ability to independently interpret and summarize complex regulatory requirements succinctly.
  • Proficiency in software platforms is preferred

    • ERP (Oracle, Workday, NetSuite)

  • Microsoft Office Suite (Word, Excel, Outlook, Teams, SharePoint)
  • Electronic Health Record System
  • Clinical Trial Management System
  • Strong organizational, problem-solving, and decision-making skills with exceptional attention to detail.
  • Familiarity with institutional and federal regulatory frameworks, including GCP and ICH guidelines.
  • Ability to manage multiple priorities and meet strict deadlines in a fast-paced research environment.

    • WORK ENVIRONMENT

  • Office-based environment with regular interaction with investigators, research staff, and sponsors.
  • Occasional travel required for site visits, sponsor meetings, and regulatory conferences.

    • 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 Wake Forest Baptist 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.

    About the Team

    Mission, Vision and Culture Commitments

    Mission

    To improve health, elevate hope and advance healing - for all.

    Vision

    To be the first and best choice for care.

    Culture Commitments

    We create a space where all Belong

    We Work as One to make great things happen

    We earn Trust in all we do

    We Innovate to better the now and create the future

    We drive for Excellence - always