Linthicum Heights, Maryland
Linthicum Heights, Maryland
Indianapolis, Indiana
Posted: 20-Sep-24
Location: Los Angeles, California
Salary: Open
Categories:
Internal Number: 142635341
The Clinical Research Supervisor oversees moderate/complex research study coordination. In this role you will manage unit operations to ensure compliance with departmental and organizational policies, procedures, and defined internal controls. Supervise operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. Oversee planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). Serve as liaison with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support.
Salary offers are determined based on various factors including, but not limited to, qualifications, experience, and equity. The full annual salary range for this position is $92,600.00 - $202,200.00. Please note that the department's target annual pay range is $92,600.00 - $147,400.00.
Required:
- Bachelor’s degree required, Master’s degree preferred or equivalent experience / training.
- Minimum of 5+ years of experience in clinical research coordination
- Minimum 2+ years of direct clinical research supervision
- Expert level experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets.
- Expert level experience with FDA processes and procedures.
- Demonstrated ability to serve as a subject matter expert, providing guidance and advice to lower-level clinical research coordinators.
- Expert level working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
- Demonstrated ability to interpret IRB, FDA, federal and UCLA requirements and utilize that information to guide investigators and other team members.
- Advanced 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.
- Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
