Clinical Research Supervisor/Coordinator – Pediatrics

Description 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: $88,900.00 – 190,300.00 Annually Qualifications 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