Clinical Quality Control Reviewer

Job description

Responsibilities: • Data Quality Review / Quality Control (DQR/QC): - Independently performs DQR/QC on clinical components of assigned documents (eg, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses, etc.). • Formally documents findings of assigned documents. • Supports accuracy, internal consistency, uniformity and compliance with clinical and regulatory commitments and expectations. • Alerts supervisor and document authors immediately if significant problems are found during a review. • After completion or throughout the review, prepares written report of findings and record of the DQR/QC. • Participates in resolution of findings with the document authors, clinicians and other members of the medicine team if necessary. • Archives relevant documentation in the appropriate repository according to established departmental practices. • Manages the completion of complex tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analyses and corrective action planning with customers as necessary. Reporting Tasks: - • Provides ongoing analysis of data resulting from the quality review of regulatory submission documents. • Records assignments in relevant tasks logs. Experience: • Minimum 3 years of clinical and data management experience in the pharmaceutical/healthcare industry. • This should also include a minimum of 3 years medical writing and DQR/QC experience of clinical documents. • An understanding of scientific principles, knowledge of medical terminology and familiarity with the AMA Manual is required. • The ability to edit to clear writing is required, as are strong verbal, written, and interpersonal communication skills, and the ability to pay rigorous attention to detail while working rapidly and accurately. Preparation of clinical regulatory documents is strongly preferred. • This experience can be obtained in a clinical setting, at a pharmaceutical company or CRO. • No Travel/No Overtime Education: • At a minimum, a scientific or technical degree. • In general candidates would have a BS degree or equivalent. Kind Regards Sukhpreet Basra Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I Direct:732-429-1921 (Tel) 732-549-2030*241 | (F) 732-549-5549 Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row) A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.