- Has a working knowledge of FDA regulations, GCP/ICH guidelines, clinic SOPs and individual protocols.
- Perform Quality Control to maintain audit and inspection readiness of studies.
- Ensures all study related communication is documented and identify any areas that need further clarification or inconsistencies to the Site Director.
- Works with the Site Director to identify training needs and organize training interventions to meet quality standards.
- Coordinates 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.
- Issues queries as applicable for all reviewed documentation and trends queries for systemic issues. Reports feedback to Director, Quality Control
- Reviews 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 of appropriate corrective actions under the guidance of Quality Assurance.
- Perform QC functions as directed by the Director of Quality Control 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, & 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 by monitors or sponsor representatives.
- Performs other duties as assigned.
- Always represents research site in a professional manner when interacting with sponsors, volunteers, outside venders and fellow employees.
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QC Specialist - Deland, United States - Latitude, Inc.
Description
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 the Director of Quality Control. Additionally, assists in 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:
Skills and Qualifications:
· Education and experience
o Minimum of two years of experience conducting or managing clinical pharmaceutical/device research studies or experience in the clinical research industry.
· Requirements
o Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
o Must be able to identify and communicate about research problems and processes across various levels of the organization.
o Good organizational and interpersonal skills
o Attention to detail.
o Must be self-motivated and able to perform tasks independently.
o Knowledgeable in medical terminology, source documentation, informed consent, IRB submissions and reporting, and electronic data capture to communicate effectively with physicians and staff.
o 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.
o Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
o Excellent communication skills (interpersonal, written, verbal)
o Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
Job Type: Full-time
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