Largo, Maryland
Gainesville, Georgia
Nashville, Tennessee
Braselton, Georgia
Posted: 10-Jan-25
Location: Los Angeles, California
Categories:
Internal Number: 145653734
The Clinical Research Supervisor provides immediate supervision to routine research study coordination. You will supervise unit operations to ensure compliance with departmental and organizational policies, procedures, and defined internal controls. You will supervise operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. The Clinical Research Supervisor oversees 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). You will serve as a 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. The responsibilities outlined in the job description provide a general overview of duties and tasks performed the role. Performance of duties and tasks will vary based on the department operations, the type of study, and scope of service.
Salary Range: $83800 - $1794000/Annually
Required:
- Bachelor’s degree or equivalent experience.
- Minimum of 5+ years of experience in a clinical research setting.
- 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 effectively communicate to and interact with patients in a compassionate and kind manner.
- 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. Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines.
- 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.
- 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.
- Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to-understand manner.
- Ability to handle confidential information with judgement and discretion.
- Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc.
- 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.
- Demonstrated ability to interpret IRB, FDA, federal and UCLA requirements and utilize that information to guide investigators and other team members.
- Expert level working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
- Demonstrated experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets.
- Demonstrated experience with FDA processes and procedures.
- Ability to lead the development and implementation of quality improvement activities, SOPs, processes, etc.
- Team leadership experience (i.e. projects, committees, etc.).
- Ability to develop and give presentations to leadership, positively representing the department.
- Ability to predict potential problems and proactively implement solutions.
- Ability to clearly communicate complex departmental and institution-wide policies and ensure understanding.
- Ability to manage complex and sometimes conflicting departmental priorities and external timelines.
Preferred:
- Master's Degree.
- Clinical Research Certification (CCRP, ACRP, etc.).
