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