Director of QA and Compliance

Come work with a growing, multi-site clinical research team!

East Coast Institute for Research (ECIR) is dedicated to developing ground-breaking new research to benefit our communities. Our research involves the latest medications and devices not yet available to the general public and is conducted at our state-of-the-art facilities in Northeast Florida and Georgia. With over 15 years of experience, ECIR maintains a positive reputation with our sponsors, our partnering clinics and our patients.

We currently have 10 research sites and continue to grow! We’re a small, family-oriented company that cares about our employees and provides an environment where learning and growth is available and encouraged. We have a clear growth plan for our clinical research staff and offer reimbursement for the credentialing process as well as other training to help our clinical staff feel prepared and successful.

We offer great health benefits that are available in less than 30 days including medical (with an HSA option with company match), dental, vision, life, and disability, so that you can make sure you and your family’s health are taken care of. We also provide ample paid time off, paid holidays, and flexible schedules. Our 401K option is available to employees after 3 months and has a company match.

Engaging with each other through continued training and fun group experiences is important to us. We try to get all 8 sites together quarterly to do team building, continued education, and just have some fun!

We’ve told you about us, now tell us about you! Apply today!

Director of QA and Compliance Job Description:

PURPOSE

East Coast Institute for Research is a rapidly growing clinical research site management organization that partners with pharmaceutical companies, CROs, and academic institutions to conduct high-quality clinical trials.

Under the direction of the Chief Growth Officer (CGO), this position will establish the overall quality program within the company. To ensure top quality throughout the ECIR Clinical Research network, this position will focus on evaluating, developing, and implementing a quality program across the Network. The quality program's effectiveness will be assessed periodically, resulting in continuous quality and process improvement.

The Director of Quality and Compliance will work closely with the COO, Site Directors, and clinical research staff to ensure quality is embedded throughout all processes and each site is “Inspection Ready at All Times”.

Responsibilities

• Evaluating, Establishing and/or Updating SOPs at all sites. Oversee the development and maintenance of quality management systems, including SOPs, training programs, and documentation processes
• Developing a standard ongoing evaluation process
• Develop and implement quality and compliance strategies to ensure that all clinical research activities meet regulatory requirements and industry standards
• Establishing, Measuring and Reporting on Quality Indicators
• Developing and Providing a Quality Training Program
• Initial & Ongoing Training; including but not limited to GCP/ICH incorporating the TransCelerate minimum criteria, HA, Impact of sponsor activities including - Risk Based Monitoring and Virtual Visits, Source Record Management
• Driving an “Inspection Ready at All Times” culture
• Leading and supporting site staff during Sponsor monitoring/Audit activities, IRB/EC Audit and Health Authority Inspections. including preparation, hosting, and resolution of any items.
• Serve as the primary point of contact for regulatory agencies and external auditors, and ensure timely and accurate responses to inquiries and findings

• Primary point of escalation for identified site quality issues and remediation of non-compliance
• Develop/implement/execute a routine quality oversight program
• Remote
• Onsite
• Supporting due diligence evaluations for new acquisitions
• Collaborating with vendor to review the evaluation and recommendation. Evaluations will focus on PI Oversight, adherence to GCP/ICH & HA regulations, appropriate written SOPs, as well as adherence to SOPs.
• Supporting & tracking site CAPAs to resolution
• Stay current on industry trends, regulatory changes, and best practices, and proactively identify opportunities for continuous improvement
• May perform other job-related duties as requested or required.
  
  

Required Knowledge, Skills And Abilities

• Sound knowledge of medical terminology.
• Well versed in the conduct of clinical trials.
• Subject matter expert of ICH/GCP, Regulatory requirements, FDA and HIPAA policies and practices.
• Experienced in FDA inspections and sponsor audits
• Excellent interpersonal skills to deal effectively with clinicians, clinical staff, regulators, monitors, and sponsors.
• Ability to balance quality with operational efficiency
• Ability to create and deliver training at all levels
• Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
• Meticulous attention to detail.
• Ability to maintain confidentiality.
• Strong verbal and written communication skills with positive interactions
• Strong organizational skills able to prioritize, delegate, direct, support, and evaluate others work and follow through on assignments.
• Proficient in the use of Microsoft Office, Microsoft Excel, and Adobe Acrobat.
• Ability to meet multiple and changing deadlines
• Demonstrate decision making skills. Curiosity and passion to learn, innovate able to communicate possible risks and get things done.
• Travel to sites required
  
  
  

Minimum Required Education, Experience And Certifications

• Bachelor's degree in a related field (Master's degree preferred)
• Minimum of 5 years of experience in quality and compliance roles in clinical research, preferrable at the site level
• In-depth knowledge of FDA regulations, ICH guidelines, and GCP standards
• Proven track record of developing and implementing quality management systems and leading successful inspections and audits
• Strong leadership and communication skills, with the ability to influence and collaborate with stakeholders at all levels
• Experience working in a fast-paced, entrepreneurial environment, and a passion for driving continuous improvement
• Supervisory experience a plus
• Travel Required