Quality Assurance Supervisor

Evolution Research Group•Miami, FL

3d•Onsite

About The Position

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. The Quality Assurance Supervisor is responsible for oversight on clinical research operations by way of inspecting and evaluating processes, procedures, and adherence to applicable regulations and guidelines. In addition to supporting Quality Control efforts with data reviews, trend identification and risk management, the QA Supervisor is also responsible for supporting QA related tasks for the site, under the supervision of the Director Quality Assurance and Compliance. This may include but is not limited to: External/Internal Audits, CAPA, eQMS maintenance, tracking trends and deliverables to completion, and assisting in education and training efforts to reduce quality related problems and increase understanding of our culture of quality. The QA Supervisor is guided by FDA regulations, ICH GCP Guidelines, and company Standard Operating Procedures and policies.

Requirements

2-year degree in a related field and a minimum of 5 years of experience conducting or managing clinical pharmaceutical/ device research studies or experience in the clinical research industry required
Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods
Understands and can train staff on regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines
Knowledgeable in medical terminology
Excellent communication skills (interpersonal, written, verbal)
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
Ability to be a leader and strong team building support initiative

Responsibilities

Working knowledge of FDA regulations, GCP/ICH guidelines, clinic SOP’s and individual protocols
Perform Quality Control to maintain audit and inspection readiness of studies
Ensure all study related communication is documented and identify any areas that need further clarification or inconsistencies to the Site Director
Work with site staff, vendors, and contract employees to obtain quality data
Review Source Documents, CRF’s, Study Documents, Logs, and Master Files with coordinators and staff to ensure quality, completeness, and accuracy
Issue queries as applicable for all reviewed documentation and trends queries for systemic issues
Report feedback to Director, Quality Assurance and Compliance
When directed, review monitor follow-up letters and ensure outstanding issues are resolved
Meet with sponsors, monitors, and auditors during their visits and document close out minutes as applicable for the Quality Team
Evaluate audit findings and oversee implementation and effectiveness or appropriate corrective actions under the guidance of Quality Assurance
Perform QC functions as directed by the Director Quality and Compliance in collaboration with Site Director input
May assist with developing new Work Practices as they relate to Quality
Comply with the confidentiality of research data
Study, learn, and comply with ERG site standard operating procedures and other policies practices and regulations where applicable
Maintain current training with SOP, WPs, CITI, GCP, and HIPAA
Process a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility and a general understanding of all active study protocols
Attend meetings, study initiation visits, and all other study-related visits by monitors or sponsor representatives as applicable
Always represent research site in a professional manner when interacting with sponsors, volunteers, outside vendors, and fellow employees
Assist with maintaining trackers and/or metrics for all aspects of the Quality Management System components
Support necessary needs for audit preparation, facilitation, or closure, inclusive of overseeing Sponsor audit report completion activities
Support the facilitation and liaising between head of QA and site staff with respect to CAPAs or other risk mitigation efforts
Subject Matter Expert (SME) for eQMS system when assigned
Provide back-end support for FDA Inspections
Site liaison for Quality Assurance/Control and responsible for bringing matters to the attention of the Director QA and/or VP Quality Assurance when appropriate
Communicate in a professional and succinct manner both internally as well as with clients when necessary
Complete tasks within the projects timelines by prioritizing multiple tasks
Demonstrate customer-oriented communication skills responding to Sponsor, management, and research team correspondence promptly
May serve as liaison between site and Sponsor Monitors/QA Auditors
Train and provide mentorship and support to operational team members as applicable as it relates to Quality Assurance/Quality Control
Keep apprised of all new FDA and GCP/ICH regulations and guidelines