Study Activation Coordinator

Job Description:
Responsibilities The mission of the UCLA Coordination Services & Education (CSE) Study Activation Team (SAT) is to provide an outsource solution to investigators and study teams that require assistance with clinical study administrative start-up and quality improvement measures to create uniform clinical research practices that can be initiated during startup and implemented through study conduct.
Our Study Activation Team would be able to assist, on a sales and service basis, with protocol development, study feasibility, budget development, budget negotiation, regulatory document collection, consent form development, IRB submissions/correspondences, contract/grant award documents, ancillary applications, operational workflows, investigator orientation to research resources, and several other study start-up activities required prior to enrollment of study participant across different clinical study phases and different department/ divisions.
For studies already open to enrollment, SAT can provide quality improvement services to ensure study setup was done appropriately.
Incumbent will report to the assigned CSE designee, CSE Assistant Director.
When assigned a study, the incumbent will work with the applicable Investigator(s), study team(s), federal and state regulatory agencies, industry partners, and other collaborating departments to initiate, coordinate, and manage investigator-initiated and sponsor-initiated clinical studies.
Incumbent will be expected to meet office goals and problem solve potential system barriers with determination and professionalism.
Qualifications Clinical research experience as a Study Coordinator in research involving human subjects, particularly the regulatory aspects of clinical research.
Working knowledge of FDA Good Clinical Practice and Good Laboratory Practice.
Ability to work efficiently and complete tasks with a high degree of accuracy.
Ability to effectively organize and manage multiple projects simultaneously.
Strong analytical skills sufficient to work and problem solve with minimal supervision.
Ability to handle confidential material with discretion in accordance with Federal, State, and local laws and regulations, and consistent with Institutional policies.
Working knowledge of Institutional Review Board & Contracts and Grants policies and procedures.
Demonstrated experience in writing research correspondence to IRB and study sponsors.
Skill in coordinating diverse, complex tasks and information transfer among administrators, staff, committee members, and investigators.
Ability to effectively respond and resolve sponsor queries, both written and verbal.
Working knowledge of informed consent forms to ensure compliance with applicable laws and Institutional policies.
Ability to track regulatory documents that include laboratory certification, CVs, IRB compliance and correspondence letters, medical licenses, FDA Form 1572, Delegation of Authority Forms, Serious Adverse Event submissions, MedWatch/IND submissions, etc.
Ability to travel, as required and assigned, to attend meetings and conferences.
Demonstrated ability to work effectively within a group as well as on independent projects.
ACRP, SOCRA, or similar research related certification.

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