Quality Control Specialist

Job Description

The Quality Control Specialist is responsible for overseeing clinical research operations by inspecting and evaluating processes, procedures, and adherence to applicable regulations and guidelines. The QC Specialist reviews data, identifies trends, and communicates incidents related to clinical research to Site Leadership and the Quality Assurance department. Additionally, the QC Specialist assists in educating and training teams to reduce quality-related problems and enhance understanding of the 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

• Work with 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 source documents, eCRFs, essential documents, logs, and procedure-required documentation 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 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.
• Oversee that implementation of action items and effectiveness checks of those items are being completed and report delays or concerns to Site Leadership or QA department as applicable.
• Perform QC functions as directed by the Site Leadership in consultation 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.

Skills and Qualifications

• Minimum of two years of experience conducting or managing clinical pharmaceutical/device research studies or experience in the clinical research industry.
• Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
• Must be able to identify and communicate about research problems and processes across various levels of the organization.
• Good organizational and interpersonal skills.
• Attention to detail.
• Self-motivated and able to perform tasks independently.
• Knowledgeable in medical terminology, source documentation, informed consent, IRB submissions and reporting, and electronic data capture to communicate effectively with physicians and staff.
• Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
• Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
• 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 RealTime CTMS).