Regulatory Coordinator - Surgery

Description

We are seeking a motivated and qualified Regulatory Coordinator to join our team. The successful candidate will support regulatory and compliance activities across a robust portfolio of investigational drug and device studies. This role requires strong communication, organizational, problem-solving, and collaborative skills, along with the ability to manage multiple priorities effectively.

The ideal candidate will demonstrate professionalism, sound judgment, attention to detail, and a strong commitment to quality and regulatory compliance. This position provides an opportunity to make a meaningful contribution to the success of clinical research programs while working collaboratively with colleagues, investigators, study teams, and other key stakeholders.

Hourly Salary Range $33.09 - $65.77. Please note, the department's target hourly salary range is*:* $35.00 - $40.00

Pay range: $33.09 - $65.77 an hour

Qualifications

Required:

• Bachelor's Degree and/or equivalent combination of education and experience.
• Minimum of 1+ years of experience as a clinical researcher.
• Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.
• Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.
• Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
• Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.
• Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met
• Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.
• A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.
• Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
• Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.