Shire Jobs

Description

Clinical Research Supervisor provides immediate supervision to routine

research study coordination. Individual supervises unit operations to ensure

compliance with departmental and organizational policies, procedures, and

defined internal controls. Supervises 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). Serves 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. 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: $78800.00 - $175000.00 Annually

Qualifications

Required:

• Bachelor's degree required, Master's degree preferred.

• 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.

• 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.

• 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.)

Preferred:

• Clinical Research Certification (CCRP, ACRP, etc.)

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