Clinical Research Coordinator Jobs

About The Position

Requirements

• Bachelor's degree in Biological Science, hard sciences, Psychology, or Sociology; equivalent experience is accepted in lieu of a degree.
• Basic Life Support (BLS) for Healthcare Providers.

Responsibilities

• Develop processes to implement research protocols safely and effectively; identify potential or actual implementation issues and initiate interventions to prevent protocol violations or unsafe practices.
• Coordinate necessary activities between Study Coordinators and the Principal Investigator.
• Perform initial and ongoing research-subject evaluations and implement, document, and evaluate care plans based on clinical consultation, standards of care, optimal outcomes, and protocol requirements.
• Perform technical skills according to policy, procedure, and TriHealth standards, and document appropriately in medical records.
• Complete study submissions and maintain compliance with IRB and FDA requirements, standards, and deadlines, including subject randomization and enrollment notifications, progress reports, reporting deaths and adverse events, and sponsor communications with the designated TriHealth IRB.
• Assess potential subjects against inclusion and exclusion criteria and maintain complete, thorough Case Report Forms according to IRB and FDA standards.
• Support hospital staff in following research protocols while minimizing workload impact; keep controllable queries and protocol violations to a minimum and respond to queries accurately and promptly.
• Maintain detailed follow-up schedules to meet regulatory time points.
• Maintain knowledge of available studies, screen potential patients for eligibility, and guide physicians and staff on timelines for capturing protocol data.
• Attend sponsor-required protocol training and meetings related to trial initiation or ongoing progress.
• Serve as the point person for audit staff conducting institutional reviews and prepare written responses and action plans for major or minor deficiencies.
• Market and network with sponsors, assess protocol feasibility, and address some budgetary issues.
• Follow the standard operating procedures of the TriHealth Hatton Research Institute.

Benefits

• Competitive shift differentials.
• Opportunities for professional growth.
• Comprehensive benefits package that may include medical, dental, vision, paid time off, retirement savings plans, and tuition reimbursement.