The Senior Clinical Research Coordinator (CRC) oversees and administers clinical research studies and associated activities. This position will assist with the management of study budgets, to include the review of monthly budget reports as well as budget forecasts to ensure that studies remain financially healthy. The Senior CRC assists in project planning, and ensures that pre- established work scope, study protocol and regulatory requirements are followed. This position may recruit and coordinate research subjects, as appropriate, and serves as principle administration liaison for the project. This position oversees and coordinates the provision of administrative and staff services to investigators; develops and maintains record keeping systems and procedures. The Senior CRC may also assist with the preparation of presentations for required review and approval processes, to include public affairs office review at USU.

Principle duties and responsibilities include, but are not limited to, the following:

Qualifications

• Bachelors degree or equivalent work experience required; masters degree preferred
• 8 years’ experience in clinical research preferred
• 5+ years non-profit, research, or healthcare experience desired
• Certified Clinical Research Coordinator (CCRC) certification preferred
• Demonstrated competence in oral and written communication
• Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor
• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
• Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software
• Knowledge of CFR, GCP and ICH guidelines

Management Responsibilities

• May manage CRCs in entry-level to mid-level roles, research assistants, and other entry level to mid-level members of the conduct team, as assigned
• The following management responsibilities are applicable to the Senior CRC in a supervisory role:
  • Assist with staffing, hiring, salary negotiations and performance review process for conduct staff
  • Conduct counseling, corrective action, up to and including termination, with Human Resources and Director
  • Oversee programmatic/study related conduct ensuring staff perform tasks within scope of project
  • Manage conduct staff to ensure optimal performance on each study
  • Ensure staff demonstrate basic understanding of their job description
  • Plan and facilitate individual and team meetings
  • Assure all staff comply with Foundation and site policies, procedures and SOPs
  • Proactively prepare and conduct site evaluation and study initiation visits
  • Ensure sponsor and Geneva enrollment/milestones, study execution, and monitoring expectations are met on 100% of all studies
  • Cognizant of and promotes networking opportunities with sponsors, subjects, and researchers

Responsibilities

• Promote safety and confidentiality of research participants at all times
• Adhere to Occupational Safety and Health Administration (OSHA), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and infection control procedures
• Plan and coordinate the initiation of research study protocol, and the implementation of operating policies and procedures
• Plan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data
• Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scope
• Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives
• Organize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectives
• Document all correspondence and communication pertinent to the research
• Interact and communicate effectively with Principal Investigator, other site personnel, research parti