Quality Control Specialist

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Full Time CPMI-Clinical Pharmacology Miami, Miami, FL, US

3 days ago Requisition

Salary Range: $58,000.00 To $62,000.00 Annually

About Company:

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.

Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.

Job Description:

The Quality Control Specialist is responsible for oversight on clinical research operations by way of inspecting and evaluating processes, procedures, and adherence to applicable regulations and guidelines. The QC Specialist reviews data, identifies trends, and communicates all incidents as they relate to clinical research to Site Leadership and where necessary, the Quality Assurance department. Additionally, assists in education and training teams to reduce quality related problems and increase understanding of our culture of quality.

The QC Specialist is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies.

Responsibilities:

• Working knowledge of FDA regulations, GCP/ICH guidelines, clinic SOPs and individual protocols.
• Perform Quality Control sampling to maintain audit and inspection readiness of studies.
• Workwith Site Leadership and the Quality Assurance department to identify training needs and organize training interventions to meet quality standards.
• Coordinate with site staff, vendors, and contract employees to obtain quality data.
• Review things such as but not limited to:
  Source Documents, eCRF’s, Essential Documents, Logs, and procedure required documentation with coordinators and staff to ensure quality, completeness, and accuracy.
• Issuequeries as applicable for all reviewed documentation and trends queries for systemic issues. Reportfeedback to Site Leadership and Quality Assurance department.
• Review essential documents and other regulatory files to ensure any outstanding issues or commitments are being managed to completion.
• Support Site leadership by assisting or facilitating onsite sponsor visits and documenting any minutes or actions where applicable.
• Overseethat implementation of action items and effectiveness checks of those items are being completed and reportdelays or concerns to Site Leadership or QA department as applicable.
• Perform QC functions as directed by the Site Leadership in consult with the QA department and Director of Training and Development.
• May assist with developing or reviewing site processes such as Work Instructions.
• 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, & HIPAA
• Possess 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 as applicable to the role.
• Always representresearch site in a professional manner when interacting with sponsors, volunteers, outside venders and fellow employees.
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs…