Job Details

COMPANY DESCRIPTION

Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages andOrlando, 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 The Villages.

POSITION OVERVIEW

The Compliance Coordinator is responsible for ensuring the integrity of clinical trial data, including both subject-specific and study-level data. The Compliance Coordinator provides support to the clinical team in performing all clinical trial activities and documentation in compliance with Food and Drug Administration (FDA) regulations and guidance documents, International Council on Harmonization – Good Clinical Practices (ICH-GCP), Charter Research SOPs, and relevant local and federal laws.

RESPONSIBILITIES

1. Provide support to clinical trial teams to ensure compliance with FDA regulations and guidance documents, ICH-GCP, SOPs, and relevant federal and local laws.
2. Maintain systems and procedures for ensuring clinical trial data integrity and quality.
3. Perform compliance reviews on subject-specific and overall study documentation to ensure the proper performance of all clinical trial activities according to protocol, FDA regulations and guidance, ICH-GCP, SOPs, and other relevant local and federal laws.
4. Perform and track compliance reviews of subject visits and study documentation to ensure proper quality control oversight of clinical trial data in accordance with relevant SOPs.
5. Communicate compliance issues to all relevant parties in a timely manner, including the Principal Investigator (PI), other relevant trial team members, and site and company leadership.
6. Assist with tracking the proper and timely reporting of compliance issues to the Institutional Review Boards (IRBs), Contract Research Organizations (CROs), and Sponsors, when required.
7. Track and coordinate follow-up on compliance issues identified through internal or external quality reviews, monitoring visits, audits, inspection, or other oversight processes.
8. Support the management of Corrective and Preventative Action Plans (CAPAs), including the implementation of all training and follow-up required, for significant compliance issues identified through internal or external quality reviews, monitoring visits, audits, inspections, or other oversight processes.
9. Support and guide site teams in the identification of root causes, development and implementation of new processes, and the completion of required training related to compliance issues identified.
10. Support the review all of protocol deviations and exceptions, ensuring documentation meets ALCOA-C standards.
11. Track all protocol deviations and exceptions, including monitoring compliance with deviation reporting guidelines set forth by the CRO, sponsor, IRB, and other oversight agencies.
12. Assist with ensuring the completion of all follow-up steps required by individual deviations.
13. Assist analysis of deviation trends and guides the development, planning, and implementation of related trainings, systems, and SOPs to successfully reduce and eliminate errors in the performance of clinical trials.
14. Understand thoroughly all assigned studies through reading protocols, attending start-up meetings, and related training, and coordinating with Principal Investigator.
15. Complete and maintain all training mandated by sponsors, Contract Research Organizations (CROs), study vendors, and Charter Research.
16. Adhere strictly to the study protocols and their associated data entry standards, utilizing the Electronic Case Report Form (eCRF) guidelines and data capture snapshots provided by the sponsor, CRO, and EDC vendor.
17. Work closely with each assigned study's Clinical Research Associate (CRA) to facilitate the sponsor and CRO data monitoring and maintenance processes.
18. Investigate and respond to all data queries in a timely manner in collaboration with members of the clinical research team.
19. Perform other duties as assigned or required

KNOWLEDGE, SKILLS, AND ABILITIES

1. Ability to handle multiple tasks/projects simultaneously.
2. Motivation to act as a champion for data integrity, quality, and regulatory excellence.
3. Exceptional communication skills, allowing the individual in this role to identify compliance issues, communicate them to individuals or groups of individuals, and effectively address them in a positive and forward-thinking manner.
4. Ability to collaborate with other team members to achieve results.
5. Excellent organizational skills.
6. Strong drive and personal initiative.

QUALIFICATIONS

Education

1. Bachelor's degree preferred.

Experience

1. Typically, at least 2 years of clinical research experience required.

PHYSICAL REQUIREMENTS

1. Prolonged periods of sitting at a desk and working on a computer.
2. Prolonged periods of standing, bending, and reaching.

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.