Clinical Research Site Manager

1 week ago

Portsmouth, United States Medix™ Full time

Requirements:

  • Must have 3-5 years of current experience with clinical research site management at the site level, not at the CRO/Pharma level.
  • Must locally reside in Portsmouth, NH or be open to relocation. Relocation assistance is available if needed.
  • This role is ONSITE, no hybrid or remote options.


Position Responsibilities:

  • Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance;
  • Collaborating with leadership to support delivery expectations, meet expected study milestones, meet budgets, and delivery quality data
  • Overseeing study team members' output and performance
  • Reviewing the performance dashboards and other clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and to ensure the data has been updated to reflect timely execution of all operational aspects
  • Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures;
  • May develop and support execution of corrective action plans at site and study level
  • Overseeing people management activities including time cards, absence tracking/approvals, new hire training, interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching and termination meetings.
  • Managing assigned site staff, proactively identifying and resolving issues, and work to ensure successful site operations;
  • Assisting with initial and ongoing trainings regarding protocol specification, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study;
  • Collaborating with investigators to ensure patient safety and meeting client goals and timelines
  • Employing problem-solving skills to propose and implement risk mitigations
  • Participating and presenting in management or site meetings
  • Perform all other duties as required or assigned.

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