QC Specialist (Must have Clinical Trial Experience)
Company: Latitude, Inc.
Posted on: May 24, 2023
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:
- 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,
- Reviews monitor follow-up letters and ensure outstanding issues
- Meet with sponsors, monitors, and auditors during their visits
and document close out minutes as applicable for the Quality
- 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
- Comply with the confidentiality of research data.
- Study, learn and comply with ERG site standard operating
procedures, and other policies, practices, and regulations where
- 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.Skills and Qualifications: - -Education and experienceo
Minimum of two years of experience conducting or managing clinical
pharmaceutical/device research studies or experience in the
clinical research industry. - -Requirementso 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 skillso
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-timePowered by
Keywords: Latitude, Inc., Deltona , QC Specialist (Must have Clinical Trial Experience), Healthcare , Deland, Florida
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