Title: Quality Control Specialist

Location: LOH

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:

• Has a 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.
• Works with Site Leadership and the Quality Assurance department to identify training needs and organize training interventions to meet quality standards.
• Coordinates with site staff, vendors, and contract employees to obtain quality data.
• Reviews of 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.
• Issues queries as applicable for all reviewed documentation and trends queries for systemic issues. Reports feedback to Site Leadership and Quality Assurance department.
• Supports Site leadership by assisting or facilitating onsite sponsor visits and documenting any minutes or actions where applicable.
• Oversees that implementation of action items and effectiveness checks of those items are being completed and reporting delays 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.

Skills and Qualifications:

• Education and experience
  • Minimum of two years of experience conducting or managing clinical pharmaceutical/device research studies or experience in the clinical research industry.
• Requirements
  • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
  • Good organizational and interpersonal skills
  • Attention to detail.
  • Must be 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.
  • Understands 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)

About us:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 21 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.