Responsibilities
Under the direct supervision of the Director of Clinical Research and general supervision of the Vice Chair for Research within the Radiology Office of Research Affairs (ORA), the incumbent will supervise departmental clinical research coordinators in various aspects of study start-up and execution of clinical research, including feasibility assessment, regulatory functions, patient study visit management, data entry and quality assurance, and oversight of sponsor and federal monitoring visits/audits.
You will also assist with the conduct of individual clinical trials with PI oversight, functioning as study coordinator for all assigned studies from initiation to closure.
The incumbent will coordinate, manage and conduct clinical research studies in close collaboration with different Departmental entities (Modality directors/managers), OCGA, Office of Research Compliance, IRB, and the CTSI Clinical Trials Administration to ensure compliance, safety and ethical conduct of clinical research trials.
You will also oversee special projects as assigned by the Director of Clinical Research, including the Departmental Manual of Standard Operating Procedures.
Qualifications
College degree or clinical research experience or analytical experience; or an equivalent combination of education and experience.
Experience in staff supervision of at least 1 year or equivalent
Skill in analyzing information, problems, situations and procedures to define objectives, identify patterns and formulate conclusions.
Skill in setting priorities, which accurately reflect the relative importance of job responsibilities.
Demonstrated ability to organize, initiate and work independently to address responsibilities; must have strong time management skills.
Skills in facilitating meetings with faculty, administrative-level professionals, research staff, etc.
from diverse backgrounds and different service sectors.
Effective interpersonal, oral, and written communication skills; knowledge of medical terminology; ability to effectively and clearly communicate research goals to faculty investigators, research team, support staff, etc.
Demonstrated ability to interact diplomatically and sympathetically with a patient population in varying degrees of health.
Demonstrated strong work ethic and dedication.
Ability to work a flexible schedule in order to meet changing priorities.
Previous experience in university-wide, state, and federal regulatory management in clinical trials.
Knowledge of the preparation of research regulatory documents, informed consents, and IRB submissions.
Ability to work closely and effectively with a variety of project personnel under a high level of stress.
Skill in using computers; working knowledge of word processing, spreadsheet, database and presentation programs.
Skill in organizing and maintaining accurate, up-to-date files and records for audits and other follow-up activities.
Experience in data management of clinical research protocols, including the completion of case report forms and other study documents.
Knowledge in FDA regulations (IND, IDE), ICH guidelines and Good Clinical Practice.
ACRP or SoCRA (or equivalent) certification.
Ability to assist in the preparation of research presentations and manuscripts of publishable quality.
UCLA is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.