Job Description

Job Description

Job Description

Salary: Based on Experience

Director of Clinical Research

The Director of Clinical Research is an experienced research professional that will oversee the Research department at Amarillo Center for Clinical Research. The Director works directly with the Principal Investigator (PI) and Sub-Investigators to aid in the recruitment and retention of research subjects. The Director supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of each study. The Director is responsible for overseeing all legal and regulatory issues, budgets, and contracts for clinical studies. By performing these duties, the Director works with the PI, sponsor, and institution to support and provide guidance on the administration of the compliance, and other aspects of the clinical study.

Essential Responsibilities:

• 
  Responsible for ensuring all FDA and GCP guidelines are strictly adhered to and follow all Standard Operating Procedures for ACCR
• 
  Act as an expert on each study, providing guidance to potential research subjects
• 
  Supports reporting and follow up of Quality Issues and CAPAs within the institution
• 
  Provide excellent leadership skills to ensure proper functioning of the research department
• 
  Oversee all legal and regulatory compliance, including budget and contract negotiations, and Confidentiality Agreements (CDA)
• 
  Recruit, instructs, and coordinates research subjects, as appropriate to specific study objectives and work scope. Must be able to screen patient charts, and have the critical thinking skills necessary to make independent decisions based on outlined screening qualifications each study presents. The expectation is minimum of one patient screened in clinic per study for average job performance.
• 
  Ensures the smooth and efficient day-to-day operation of research and data collection activities
• 
  Act as the main point of contact for all clinical research studies
• 
  Manage patient visit schedules
• 
  Responsible for hands on patient care, including rooming subjects, vital signs, EKG's, lab draws, processing specimens, and other clinical tests as needed
• 
  Enter data into Electronic Data Capture (EDC) and answer queries
• 
  Delegate study responsibilities to junior employees
• 
  Provides training on GCP and other compliance and quality related topics, as required, to improve quality and expertise of employees
• 
  Manage regulatory documents and maintain study files
• 
  Attend monthly calls with Clinical Research Organizations (CROs) and investigator meetings, as needed
• 
  Manage all submissions to Central Institutional Review Board (IRB)
• 
  Manage social media accounts
• 
  Review and sign off on employee hours and time sheets

Job Tags

Similar Jobs