Quality Control Specialist

Evolution Research Group•Miami, FL

23d•$58,000 - $62,000

About The Position

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.

Requirements

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.
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.
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)

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.
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 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.
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 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 represent research 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 of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.