Sr. Clinical Research Coordinator

Responsibilities

• Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAA
• Identify, schedule and/or conduct participant study visits, tests and/or interviews/telephone follow up calls
• Coordinate participant remuneration/compensation per protocol
• Maintain all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditors
• Identify issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance
• Document and collect data and/or samples for research related procedures performed during participant study visits
• Ensure clinicians and/or PI accurately document their study activities according to protocol
• Track and maintain study enrollment and completion of milestones
• Aid with financial / operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframe
• Track and maintain study related information in the data management system within the required timeframe
• Responsible for monitoring the inventory of research related supplies
• Participate in grant preparation, manuscript writing, data presentations and Institutional Review Board (IRB) processes
• Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs
• Present study status reports related to assigned research projects
• Participate in the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• Ensure strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines
• Comply with all safety and infection control standards appropriate to this position
• Adhere with established policies, health and safety regulations and requirements, procedures, and department objectives
• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices
• Practice discretion and adhere to school and hospital confidentiality at all times
• Perform other duties as required

Qualifications

• Required for Clinical Research Coord I: Bachelor’s degree in a scientific or health related field, or equivalent experience; 0-1 year of related experience
• Required for Clinical Research Coord II: Bachelor’s degree in a scientific or health related field, or equivalent experience; 1-3 years of related experience
• Required for Clinical Research Coord III: Bachelor’s degree in a scientific or health related field, or equivalent experience; 3-5 years of related experience
• Required for Sr Clinical Research Coord: Bachelor’s degree in a scientific or health related field, or equivalent experience; 5-7 years of related experience
• Demonstrated knowledge of quality management principles in a scientific or hospital setting