Clinical Research Supervisor 1 - Pediatrics

The Department of Pediatrics Clinical Research Excellence
at Work (CREW) Clinical Research Coordinator Supervisor is an experienced
professional responsible for overseeing, coordinating, and managing complex
investigational drug clinical trials, as well as supervising other clinical
research coordinators. This role involves close collaboration with principal
investigators, study sponsors, university administrators, and regulatory
agencies to ensure efficient study operations while upholding high standards
for data quality, participant safety, and overall experience. The CREW Clinical
Research Coordinator Supervisor plays a key role in addressing operational
challenges, supporting staff development, and contributing to process improvement
initiatives and corrective action plans. They help ensure the integrity of
clinical trials by participating in study implementation, participant
recruitment, data collection and monitoring, and maintaining compliance with
institutional policies, Good Clinical Practice (GCP), and applicable federal
regulations. In addition, the CREW Clinical Research Coordinator Supervisor
oversees the daily activities of clinical research coordinators to ensure
studies are conducted efficiently and in compliance with all requirements. Core
supervisory responsibilities include managing staff schedules, providing
training and mentorship while reinforcing adherence to institutional policies
and regulatory standards, GCP and FDA regulations.

Salary Range: $86,400.00 - 184,800.00 Annually

Required:

• Bachelor's degree and/or equivalent combination of
  education and experience.
• A minimum of 3 years prior experience in professional
  postgraduate clinical research coordination
• 
  Prior experience with a clinical research management system such as OnCore.
  Prior experience using an electronic health record such as Epic for clinical
  research purposes.
• Demonstrated knowledge of all components of the research
  process as it pertains to clinical trials and studies, i.e., IRB procedures and
  processes, participant recruitment and retention, data reporting, etc.
• Strong working knowledge of Good Clinical Practices (GCP),
  the International Council for Harmonization and US federal guidelines and
  regulations for clinical research.
• Prior experience with interventional investigational drug
  clinical trials.
• Strong communication skills and experience working with
  cross functional teams.
• Strong computer skills including use of Word, Excel,
  PowerPoint, Outlook, Adobe, e-mail and databases to create reports,
  correspondence and other documents as required.
• Capable of multi-tasking and managing deadlines, balancing
  assignments from multiple individuals.
• Demonstrated understanding of confidential information, how
  it is defined, and demonstrated skill in maintaining confidential status of
  such information.
• Willingness to maintain a positive, determined attitude in
  achieving difficult objectives in a dynamic, complex, ever-evolving work
  environment.
• Demonstrated interpersonal and communication skills to work
  with patients, their families/ guardians, physicians, administrators, work
  colleagues, representatives from sponsors and others to achieve maximum
  efficiency in reaching and maintaining workplace goals in a professional
  manner.
• Skill in preparation of accurate and timely reports and
  statistical information on all protocols as needed.

Preferred:

• Certificate in clinical research administration such as
  CCRP, ACRP, or equivalent.
• Prior supervisory or mentorship experience.
• Previous experience working with a range of clinical
  research specialty content areas and sponsors including NIH and industry
  sponsored trials. Experience conducting clinical research involving