Title: Quality Control Specialist

Location: Endeavor Clinical Trials

Job Description:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late stage neuroscience drug development. With 21 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

Responsible for a variety of clinical research operations duties of a routine and technical nature in support of clinical trials. Including but not limited to the development, implementation and monitoring of quality assurance and quality control activities. Responsible for assisting the clinical team to produce the highest quality clinical research data possible. In executing these position responsibilities, the Quality Assurance/Compliance Coordinator 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 GCP/ICH guidelines, clinic SOPs and individual protocols
• Perform Quality Assurance and Control to maintain audit 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
• Reviews 100% of the consent documents on assigned trials. QC’s 100% of source documents on study when possible
• Compiles review sheets for each CRF reviewed, which includes the error, a description of the correction (if necessary), and the name of the coordinator who is to make the correction
• Works closely with monitors to facilitate timely turnaround of study queries and data entry
• Reviews monitor follow-up letters and ensure outstanding issues are resolved
• Assists and coordinates monitor corrections
• Meet with sponsors, monitors, and auditors during their visits
• Prepare for audits and inspections as needed
• Evaluate audit findings and implement appropriate corrective actions
• Assist with data entry including sponsor eCRF and clinical trial management systems (ie: Study Manager/RealTime) as directed by the Site Director
• Perform QC/QA function as directed by the Site Director and under the guidance of the Vice President of Quality Assurance
• 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

Skills and Qualifications:

• Education and experience
  • Minimum of three years of experience conducting or managing clinical pharmaceutical/device research studies or experience in the clinical research industry
  • Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines
  • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner
  • Knowledgeable in medical terminology, source documentation, informed consent, IRB submissions and reporting, and electronic data capture so as 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
• Requirements
  • Excellent communication skills (interpersonal, written, verbal)
  • 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
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)