Clinical Research Unit Supervisor

Job Description

We are seeking a Clinical Research Unit Supervisor to lead and oversee the coordination of HIV and other infectious disease clinical trials. In this role, you will provide direct supervision to research staff and ensure the smooth operation of study activities from design and setup through conduct and closeout. You will manage unit operations to guarantee compliance with departmental policies, organizational standards, and regulatory requirements, including FDA Code of Federal Regulations (CFR), ICH Good Clinical Practice (GCP), and institutional procedures.

As a key liaison, you will collaborate with Principal Investigators, sponsors, central research infrastructure teams, ancillary departments, and other stakeholders to support all aspects of study administration - including compliant study conduct, financial oversight, and personnel management. Your leadership will ensure studies are executed efficiently, ethically, and in full alignment with protocol and regulatory guidelines. This role offers the opportunity to make a meaningful impact on research operations while mentoring a team and supporting high-quality clinical research a leading academic research institution.

Salary: 85-175k

Skills and Requirements

• Bachelor’s Degree in related area and or equivalent experience.
• Minimum of 5+ years of experience in a clinical research setting
• 2 years of leadership experience managing people and operational workflows within Clinical Research
• Strong knowledge and experience with various types of trials, including the below: ○ Industry AND PI initiated trials ○ Local AND external IRBs ○ Interventional drug trials
• Knowledge of clinical trials budgeting processes, ability to work alongside budgeting team effectively
• Ability to lead the development and implementation of quality improvement activities, SOPs, processes, etc.
• Demonstrated ability to prepare for, facilitate, and respond to site monitoring visits and audits in compliance with FDA, GCP, ICH guidelines, and sponsor requirements.
• Ability to interpret IRB, FDA, and federal requirements and utilize that information to guide investigators and other team members.
• Strong experience with Microsoft and Adobe Suite
• Preferred trial experience with ○ NIH funded trials ○ HIV and/or other infectious disease clinical trials
• Academic or large hospital background
• Working knowledge and understanding of NIH Division of AIDS (DAIDS) policies, procedures, and operations
• Familiarity with systems including Epic EMR and Oncore
• Clinical Research Certification (CCRP, ACRP, etc.)
• Experience with laboratory standards and functions including Good Clinical Laboratory Practice (GCLP) Demonstrated experience with FDA processes and procedures - past experience with an FDA audit

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.