Director, Clinical Research

University of Miami

Quick summary

Work type
On-site
Location
Miami, FL
Posted
3 days ago
Nearby
99+ roles within 25 mi

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Salary context

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Similar $231k
$158k most similar roles pay here $294k

This listing doesn't post a salary. Most similar roles pay $196,249–$264,850.

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About University of Miami

The University of Miami is a private research university in Coral Gables, Florida, known for programs in business, law, medicine, marine science, and the arts. Industry: Higher Education & Research

University of Miami currently has 31 open roles on FindRole.

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At a glance

TL;DR · Director, Clinical Research

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The University of Miami/UHealth Department of SCCC is seeking a Full-Time Director, Clinical Research to lead and oversee clinical trials and research studies at their Miami campus. This senior-level role involves developing and implementing strategic plans, ensuring regulatory compliance, training staff, collaborating with cross-functional teams, and interfacing with domestic and foreign regulatory agencies. The director will manage IND/IDE submissions, review protocols for feasibility, analyze data throughout the study lifecycle, and modify SOPs to maintain compliance. Essential skills include a Master’s degree in a relevant field, at least seven years of experience, knowledge of business and management principles, and the ability to establish department goals that align with strategic objectives. This position plays a crucial role in advancing medical research through rigorous adherence to regulatory standards and effective collaboration across various departments.

Skills

Python SQL Excel R SAS SPSS Regulatory Affairs Clinical Trials FDA Regulations IND IDE Quality Assurance Project Management CRO Consultants Research Methodologies Data Analysis Protocol Development GCP ICH Guidelines

What you'll do

  • Develops and implements strategies for clinical trial oversight and study implementation.
  • Ensures compliance with regulatory standards throughout all phases of clinical trials.
  • Designs training programs to enhance understanding and future compliance among teams.
  • Oversees the preparation and submission of IND/IDE applications to FDA.
  • Analyzes data and determines corrective actions in case of major deviations from protocols.
  • Coordinates cross-functional teams for pre-clinical, clinical, and CMC activities.
  • Serves as primary point of contact with FDA for all University-held INDs and IDEs.

What we're looking for

  • Minimum 7 years of clinical research or related experience
  • Master’s degree in a relevant field
  • Expertise in regulatory compliance for clinical trials
  • Ability to develop and implement strategic goals and objectives
  • Experience collaborating with cross-functional teams and external vendors
  • Proficiency in reviewing and modifying SOPs, processes, and policies
  • Strong communication skills for interactions with FDA and key stakeholders

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