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POST DATE 8/12/2016
END DATE 10/13/2016
University of California - Los Angeles Medical Centers
Los Angeles, CA
JOB DESCRIPTIONAPPLY Job Title:
Analyst, Administrative, Sr
Weyburn 3rd Floor-Westwood, CA.
$25.53 / $4442
$50.37 / $8765
Layoff Referral Deadline:
The mission of the Coverage Analysis team within DGSOM's Clinical Trials Administration Office (CTAO) is to assist faculty and staff in navigating the pre-award process for clinical trials in a streamlined and expedited fashion and provide project continuity during the pre-study approval process. The goal of the Coverage Coordinator is to coordinate receipt of required study documents necessary to perform Coverage Analysis review. The Coverage Coordinator will perform preliminary review of study documents to confirm the accuracy and integrity of submissions. The incumbent will perform basic and intermediate Coverage Analysis reviews. In addition, the Coverage Coordinator will assist the Coverage Analysis team in performance of their underlying mission to the Health System, including but not limited to: study startup facilitation, budget development, and liaison with other administrative research offices to streamline and triage study startup processes. The incumbent will foster effective and cooperative relationships with contracting, IRB, OCGA, CIRC, EFM, OIPA, and other administrative units. The position requires strong skills in time management, multi-tasking, organization, and customer service. The incumbent should have experience in the clinical research environment, particularly familiar with basic protocol design, applicable laws and guidelines, and an understanding of pre-award processes as related to clinical research.
A. Coordinate Coverage Analysis document receipt and review.
A.1. Correspond with Investigators and Study Teams to coordinate receipt of required study documents necessary to perform Coverage Analysis review and maintain Coverage Analysis intake and tracking information promptly.
A.2. Perform preliminary review of study documents submitted for Coverage Analysis review to confirm accuracy and integrity of submissions.
B. Continuous process improvement and updating of policies, procedures, and website.
B.1. Continuously identify process improvement needs and contribute to the development and implementation of improvements. May participate on various working groups to address broader research process related projects.
B.2. Ensure DGSOM CTAO databases and website information regarding pre-award processes and other educational information are up-to-date. Assume responsibility for specific content areas in the website.
C. Develop and conduct training needs assessment and training programs.
C.2. Contributes to development and implementation of training materials and workshops under the leadership of the DGSOM CTAO Director and Assistant Director.
C3. Assist Coverage Analysis Team in the planning and execution of DGSOM CTAO educational activities such as the \\"Coordinator Forum\\" and budgeting workshops.
Education: Bachelors Degree, preferably in biological sciences or equivalent experience or at least 2 years in the clinical research environment.
Education: Bachelors degree in biological sciences preferred.
CCRP, ACRP or similar research related certification preferred.
Min. Years of Experience: At least 2 years recent experience as a clinical research professional involving hands-on IRB submissions and/or study budgeting duties.
Demonstrates expertise in protocol assessment, IRB submission, and clinical trials budgeting/negotiation.
Strong working knowledge of the full range of pre-award activities related to clinical trials research (e.g., IRB, ISPRC, CIRC/ISRC, GCRC, other regulatory approvals, etc.)
Knowledge of medical terminology.
Experience working with faculty, administrators, and staff in an academic medical center, health care or university environment
Knowledge of research regulatory requirements (including FDA and other federal and state regulations), GCP/ICH guidelines, and special requirements for drug and medical device trials, as well as ICD and CPT coding and clinical research billing modifiers.
Familiarity with industry contracting or the ability to learn and grasp basic clinical trials contracting concepts.
Proven ability to communicate effectively and participate multidisciplinary discussions regarding the health sciences campus research process and related details to a wide audience (scientists, physicians, nurses, staff, sponsors, and the general public.)
Ability to design and manage efficient work processes, set and meet expected turnaround time goals on an ongoing basis and monitor, analyze, and improve processes on an ongoing basis, and work in a time-sensitive environment.
Ability to be flexible and adapt within an ever-changing, dynamic, service-oriented environment and operate effectively within a team.