Clinical Site Manager

4 weeks ago


Rochester, New York, United States Rochester Clinical Research Full time

****Relocation Assistance Available****

Job Summary

The Clinical Site Manager is responsible for the overall management of the life of a clinical trial, overseeing the work of Study Coordinators and Clinical Research Nurses to ensure efficiency and success of the applicable trial.

Key Responsibilities

Team Leadership and Coordination

  • Supervise and mentor Study Coordinators and Clinical Research Nurses
  • Provide training and ensure all staff is familiar with the study protocol, ethical guidelines, and safety requirements
  • Foster effective communication among all stakeholders

Clinical Responsibilities

  • Be the expert on assigned trials; understanding and implementing the protocol.
  • Create study timelines and execution planning (IP delivery, lab kits, etc)
  • Involved in all study planning - monitor communications, attending IM + SIV, approving source creation (paper and electronic)
  • Be able to act as the backup to the coordinators
  • Serve as primary escalation and contact for resolution of issues that arise throughout trial for both internal and external teams

Regulatory Responsibilities

  • Managing internal greenlight process - ensuring all training and delegations are appropriately signed and completed, collaborating with regulatory
  • Maintain all appropriate documentation throughout the trial
  • Ensure all invoiceables are captured correctly for studies
  • Work with QA to evaluate root-cause analysis of CAPA's

Educational Responsibilities

  • Collaborate with new clinical staff to ensure adequate development of CRN's/SC's
  • Be a resource and educator for all coordinators

Qualifications

  • Strong team leadership and management skills
  • Strong verbal and written communication skills
  • Strong interpersonal and customer service skills
  • Strong organizational skills and attention to detail
  • Strong time management skills with a proven ability to meet deadlines
  • Strong analytical and problem-solving skills
  • Ability to prioritize tasks and to delegate them when appropriate
  • Ability to function well in a high-paced environment

Education and Experience

  • Bachelor's or Associates degree in health or science related field required
  • 3-5 years of experience in clinical research, with at least 2 years in a managerial role overseeing clinical studies or trials


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