Compliance Director - Charter Research

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 or The Villages.

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