Experience:
No experience
Employment Type:
Full time
Posted:
9/11/2017
Job Category:
Research
Industry:
Health Care & Medicine
Senior Study Activation Team Coordinator
(This job is no longer available)
UCLA Health | Los Angeles, CA
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Job Description

Job Duties
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.. SAT 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. Quality Improvement Responsibilities · Develop and implement quality improvement measures aimed at assisting investigators conduct clinical research that is compliant with applicable laws, institutional policies, study specific protocols, and regulations, including but not limited to: FDA CFRs, FDA Good Clinical Practice (GCP), FDA Good Laboratory Practice (GLP), other Federal Agencies' requirements (i.e., NIH guidelines), HIPAA regulations and applicable laws · Develop corrective and preventive action (CAPA) plans for audit findings, inspection reports or as requested by a reviewing committee · Assist investigators with implementing a defined corrective action plan, which can study management, data management or regulatory activities Regulatory · Coordinate and participate in pre-enrollment research activities for clinical studies conducted by department faculty · Assist in completion of study feasibility assessments with supervisor and study Investigator(s) for investigator initiated studies Study Activation · Coordinate and participate in pre-enrollment research activities for clinical studies conducted by department or division faculty. · Coordinate pre-enrollment monitoring visits, including Site Qualification Visits, Site Initiation Visits. · Assist in completion of study feasibility assessments with supervisor and study Investigator(s) · Assist in protocol development of investigator initiated studies, in collaboration with FDA Affairs team · Oversee and manage compliance with all Federal, State, and local laws and regulations, including but not limited to: FDA CFRs, FDA Good Clinical Practice (GCP), FDA Good Laboratory Practice (GLP), other Federal Agencies' requirements (i.e., NIH guidelines), HIPAA regulations and applicable laws and regulations governing clinical research endeavors. Training Assist in development and implementation of training materials related to quality improvement measures, FDA submission, corrective action plans, workflow analysis and ad hoc topics as assigned by supervisor

Job 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 multi-task and prioritize effectively Ability to work flexible hours to accommodate research deadlines Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines Ability to be flexible and prioritize constantly shifting workload . Strong interpersonal communication skills to effectively and diplomatically interact with others Strong written communication skills to compose correspondence Strong computer skills and experience working with Microsoft Office Applications, and able to perform the following tasks effectively: word processing, use and development of spreadsheets, e-mail and data entry (MAC, PC, MS WORD, MS EXCEL, MS OUTLOOK). Sufficient computer and computer networking knowledge sufficient to problem solve common hardware and software problems. 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, CV's, 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

About UCLA Health

For more than half a century, UCLA Health  has provided the best in healthcare and the latest in medical technology to thepeople of Los Angeles and throughout the world. Today we are one of the most comprehensive and advanced healthcare systems in existence. We are comprised of Ronald Reagan UCLA Medical Center, UCLA Medical Center, Santa Monica, Resnick Neuropsychiatric Hospital at UCLA, Mattel Children’s Hospital UCLA, and the UCLA Medical Group, with offices throughout the region.

Ronald Reagan UCLA Medical Center is consistently ranked by U.S.News & World Report as one of the top five hospitals in the nation and the best medical center in the western United States. The doctors, scientists and caregivers of UCLA are leaders in their fields. Every day, they perform pioneering work across an astounding range of disciplines, from organ transplantation and cardiac surgery to neurosurgery and cancer treatment. Year after year, our people have achieved medical breakthroughs and earned the highest industry honors. And we’re just getting started.

The dedicated professionals of UCLA Health are committed to healing humankind, one patient at a time, by improving health, alleviating suffering, and delivering acts of kindness on a daily basis.