Current jobs related to Compliance Director - Orlando FL United States - Charter Research

  • Compliance Director

    2 days ago

    Orlando, United States Charter Research Full time

    Compliance DirectorOrlando COMPANY DESCRIPTIONCharter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and prides itself on providing exceptional patient...

  • Compliance Director

    3 days ago

    Orlando, United States Charter Research Full time

    Compliance DirectorOrlando COMPANY DESCRIPTIONCharter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and prides itself on providing exceptional patient...

  • Director, IT Architecture and Compliance

    4 weeks ago

    , FL, United States SherlockTalent Full time

    Job ID: 7210 Role: Director, IT Architecture and Compliance Location: REMOTE Compensation: DOE Job Type: Full Time/Perm OVERVIEW: The Director of IT Architecture and Compliance is in charge of assisting the business in choosing investments that strike a balance between short-term operational demands, disruptions, and opportunities, and the organization's...

  • GCP Compliance Director

    4 weeks ago

    Orlando, United States RoKo Staffing Consulting, LLC Full time

    GCP Compliance Director: Permanent JobLocation: Orlando, FL The GCP Compliance Director leads the company's Compliance Team, ensuring adherence to regulatory standards, data integrity, and clinical research compliance. Key responsibilities include managing quality assurance, regulatory affairs, and risk analyses, overseeing audits and inspections, ensuring...

  • Director - Compliance Services

    3 weeks ago

    , ME, United States Witt O'Brien's Full time

    Director - Compliance Services Are you looking for an opportunity to join a team that makes a real difference? Do you want to be part of a collaborative team that protects and strengthens communities and businesses? If you are looking for all these opportunities and more, then Witt O’Brien’s is the right fit for you. Position Summary Witt...

  • Charter Research | Compliance Director

    4 days ago

    orlando, United States Charter Research Full time

    Compliance DirectorOrlando COMPANY DESCRIPTIONCharter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and prides itself on providing exceptional patient...

  • Training Director for Quality and Compliance

    1 week ago

    Orlando, Florida, United States Hilton Grand Vacations Full time

    Job Overview:We are seeking a highly experienced Training Director for Quality and Compliance to lead our training and quality assurance efforts. As a key member of our leadership team, you will be responsible for developing and implementing comprehensive training programs that meet national standards and improve the skills and knowledge of our Quality...

  • Associate Director, Compliance

    3 weeks ago

    Parsippany, NJ, United States Pacira BioSciences, Inc. Full time

    About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions...

  • Compliance Director

    4 weeks ago

    Dallas, TX, United States Westlake Services, LLC Full time

    Covered Care | Corporate Office Dallas, TX, USA Operational: Develops, initiates, maintains, and revises policies and procedures for the general operation of the organization’s compliance program and its related activities to prevent illegal, unethical, or improper conduct. Manages day-to-day operation of the Program. Investigates and resolves compliance...

  • Group Director, Environmental Compliance

    2 days ago

    Stoneham, MA, United States Mabbett & Associates, Inc. Full time

    Description Mabbett & Associates, Inc. (Mabbett®) is an award-winning and industry leading environmental, health and safety (EH&S) consulting and engineering firm. Mabbett provides consulting services to a wide variety of clients, including those in the healthcare, biotechnology, research and development industries, as well as federal agencies and academia....

  • Director of Equity Compliance Education

    4 weeks ago

    Providence, RI, United States Brown University Full time

    Brown University Director of Equity Compliance Education Providence , Rhode Island Apply Now The Director of Equity Compliance Education will bring both a deep understanding of Title VI, Title VII, Title IX and ADA/504 compliance legal requirements and practice especially in a Higher Education context. This position will lead and ensure required...

  • Director, Credit

    3 weeks ago

    Detroit, MI, United States Enterprise Community Partners Full time

    Job Description Summary Enterprise co-founded Power Forward Communities (PFC), a landmark coalition with some of the country's most trusted community development, climate, and housing organizations. It is purpose-built to decarbonize America's homes and drive a market transformation that cuts costs, benefits renters and homeowners, and focuses on low-income...

  • Director of Operations

    4 weeks ago

    Lincolnshire, IL, United States Director of Operations Full time

    Our client is looking for a Director of Operations based in Lincolnshire, Illinois. Position Summary The position is accountable for leading the Operations teams of the company, to include customer service, warehouse operations, cleanroom packaging team, purchasing and IT /facility infrastructure.This position is responsible for ensuring compliance to the...

  • Vice President, Chief Compliance Officer

    3 weeks ago

    Orlando, FL, United States Hilton Grand Vacations Full time

    We are a global team of memory makers, collaborators, industry leaders, innovators and so much more. We believe amazing vacations and experiences start with teams as diverse as the customers and communities we serve. At Hilton Grand Vacations, your future is bright! The Chief Compliance Officer plays a critical role in ensuring that an organization adheres...

  • Director, Research Compliance

    3 weeks ago

    Houston, TX, United States University of Houston System Full time

    Department: Research & Sponsored Programs Salary: Commensurate with education and experience. Description: The Director, Research Compliance is responsible for ensuring both ethical and legal requirements are known and observed in the conduct of all research and sponsored program activity. In addition, this position serves as the liaison between the...

  • Associate Director

    4 weeks ago

    , CO, United States JTC Group Full time

    Role Overview To ensure that the JTC Guernsey's Licensees and Clients Licensees (collectively, the ‘Licensees’) businesses have robust arrangements to assist in the identification, assessment, monitoring and management of risks. To enhance the risk management infrastructure in which to advise and support the Licensees with customised, proportionate...

  • Associate Athletic Director for Compliance

    4 weeks ago

    Fort Collins, CO, United States NCAA (National Collegiate Athletic Association) Full time

    The Associate Athletic Director for Compliance reports to the University President with an indirect reporting line to the University Chief of Staff and the Director of Athletics (or designee). This position will lead the departmental athletics compliance program by creating, maintaining, and monitoring a compliant environment that results in clear...

  • Director Of Nursing

    3 weeks ago

    Orlando, FL, United States Empire Care Centers Full time

    The Meadows Center for Nursing and Healing is Hiring a Director of Nursing (DON)! Excellent Pay, Great Work Environment and Culture!! Director of Nursing (DON) Overview: The Meadows Center for Nursing and Healing is a SNF seeking a Director of Nursing for a great opportunity in Sarasota, FL. We pride ourselves on our exceptional employee culture and the...

  • Trade Compliance Director

    4 weeks ago

    Louisville, KY, United States Resideo Full time

    Utilize your International Trade Compliance expertise in a manufacturing and distribution environment to lead a global Trade Compliance team. You will leverage your technical experience and knowledge to achieve Trade Compliance across ADI Global Distribution. You are expected to collaborate with internal and external stakeholders to support sales,...

  • Medical Director FL

    4 weeks ago

    Orlando, FL, United States Pailin Group Psc Full time

    The Medical Director is responsible for projecting and integrating the Mission and Core Values of the organization as well as Management’s Philosophy in the leadership of the Healthcare Center. Includes the following. Other duties may be assigned Responsible for chart review and peer review following the guidelines established by the Policies and...

Compliance Director

2 months ago

Orlando FL United States Charter Research Full time

Compliance Director

Orlando

COMPANY DESCRIPTION

Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsors. Above all, we are a team, and we are seeking the right team member to add to our foundation in Orlando.

POSITION OVERVIEW

The Compliance Director is responsible for leading the company’s Compliance Team, including oversight of regulatory affairs, source development, data management, quality assurance, and compliance. The Compliance Director is responsible for ensuring that the company’s data collection meets ALCOA-C standards and that all clinical research activities are conducted in accordance with ICH GCP guidelines, FDA regulations and guidance documents, Charter Research SOPs and work instructions, and applicable federal and state regulations and guidelines.

RESPONSIBILITIES

  1. Develop, implement, and maintain quality assurance standards and practices, ensuring adherence to protocols, data integrity, and patient safety in all clinical research activities.
  2. Design and implement compliance plans, risk analyses, and key compliance initiatives.
  3. Work closely with compliance and clinic teams to ensure “inspection readiness” across all sites at all times.
  4. Oversee internal audits, sponsor audits, and FDA inspections of selected research studies and/or clinical processes.
  5. Plan and lead the execution of day-to-day activities for quality control checks, data collection, regulatory requirements, deviation and SAE tracking, and CAPA tracking and follow-up.
  6. Oversee the management of all version-controlled documents, including SOPs, Work Instructions, and Forms, ensuring they are kept up to date and reflect the operations of the company.
  7. Provide compliance and regulatory guidance and direction to senior site leadership and staff.
  8. Prepare presentations, reports, policies, and Corrective and Preventative Action (CAPA) plans to address gaps and findings to ensure compliance and regulatory standards are continuously met.
  9. Ensure the timely reporting of compliance issues to Institutional Review Boards (IRBs), sponsors, and/or Contract Research Organizations (CROs), if required.
  10. Analyze deviation trends and guide the development, planning, and implementation of related trainings, systems, and SOPs to reduce or eliminate errors in the performance of clinical trials.
  11. Utilize quality performance metrics to identify areas of low performance and implement process improvements.
  12. Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES

Carry out supervisory responsibilities in accordance with the company’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; coaching and mentoring employees; and addressing complaints and resolving problems. Responsible for the overall direction, coordination, and evaluation of the assigned departments.

KNOWLEDGE, SKILLS, AND ABILITIES

  1. Knowledge and experience in audits conducted by industry sponsors and inspections conducted by the Food and Drug Administration (FDA).
  2. Ability to lead, speak, and be a champion for data integrity, quality, and regulatory excellence.
  3. Strong analytical, critical thinking, and writing skills, with proven ability to identify and implement process improvements in clinical research operations.
  4. Expert communication and presentation skills, with experience, poise, and confidence to represent the company professionally in front of sponsors, CROs, and FDA inspectors.
  5. Demonstrated ability to manage teams professionally, leading them to successful program administration.
  6. Proven ability to create a comprehensive company-wide compliance plan and successfully direct the implementation of all aspects of the plan.
  7. Excellent planning and organizational skills.
  8. Strong drive and personal initiative, with a desire for action and results.
  9. Detail oriented and able to handle multiple projects and tasks simultaneously.
  10. High level of personal integrity.

QUALIFICATIONS

Education

  1. Bachelor’s degree required – preferably in research administration, healthcare administration, business administration, legal or regulatory studies, biomedical, science, or another research-related field.
  2. Master’s degree preferred – preferably in research administration, healthcare administration, business administration, legal or regulatory studies, biomedical, science, or another research-related field.
  3. CCRC, ACRP-CP, CCRP, CHRC, or another professional research certification strongly preferred. Certificate must be issued by the Association of Clinical Research Professionals (ACRP), the Society of Clinical Research Associates (SOCRA), or another similar certification association held in high esteem by the clinical research industry.

Experience

  1. Extensive clinical trials experience, including:
  2. At least three (3) years of clinical research compliance-related responsibilities, focused in regulatory, compliance, and/or quality assurance; and
  3. At least two (2) years of experience conducting or overseeing internal audits or inspections of research studies or processes.
  4. Proven record of accomplishments in a clinical trials operations or compliance management role.
  5. At least three (3) years of experience managing a team.

PHYSICAL REQUIREMENTS

  1. Prolonged periods of sitting at a desk and working on a computer.??????

Charter Research provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, genetic information, marital status, ancestry, protected veteran status, or any other characteristic protected by applicable federal, state, and local laws.