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Regulatory Coordinator

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POST DATE 8/12/2016
END DATE 10/18/2016

University of California - Los Angeles Medical Centers Los Angeles, CA

Company
University of California - Los Angeles Medical Centers
Job Classification
Full Time
Company Ref #
H82537
AJE Ref #
575862580
Location
Los Angeles, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
Job Title:
Regulatory Coordinator

UCLA Title:
Analyst, Public Administration

Job No.:
H82537

Work Hours:
8am - 5pm

Work Location:
Westwood, CA

Job Type:
Career

Duration:
Indefinite

Minimum Salary:
$21.75 / $3784

Maximum Salary:
$42.88 / $7462

Layoff Referral Deadline:


Bargaining Unit:
99



JOB DUTIES:

The Regulatory Coordinator will work with the Network Clinical Research Team and UCLA study teams that support the JCCC Clinical Research Unit, the UCLA/Translational Research in Oncology-US, Inc. (TRIO-US), and the Community Oncology Research Networks, in the set-up and conduct of network clinical trials. Assist with the coordination of study regulatory set-up for all Network clinical trials. Work with the UCLA Study Teams and Pharmaceutical sponsors and CROs in preparing, compiling and shipping required regulatory documents. Respond to and resolve sponsor queries-written and verbal, and assist with the review and preparation of Network site study consent forms. Prepare and submit Network site study-specific regulatory documents to central IRB for review. Track approvals and follow-up with continuing review reports and amendment submissions as needed. Assist with tracking, maintaining and keeping required regulatory documents current. Conduct annual regulatory reviews and updates. Maintain Network database and prepare and maintain Network Study Regulatory Binders. Prepare for and assist with Sponsor and internal monitoring visits and reviews for Network Regulatory documents. Assist in preparing for internal and external audits. Maintain site lists, phone lists, required regulatory documents. Prepare and assist with Network mailings. Disseminate necessary study information to Network sites. Work with the Network Regulatory Affairs Team which supports the UCLA/Community Oncology Research and Translational Research In Oncology-US, Inc. Network sites. Collaborate with Network Staff and the Clinical Research Unit in the conduct of clinical trials Network practices are located throughout United States and may also assist with International sites as required.



JOB QUALIFICATIONS:

Clinical research experience in an administrative position in the subspecialty of Hematology-Oncology. One year experience with regulatory document submission to central IRB for review, followed by document tracking and follow-up, with continuing review report and amendment submissions as needed. One year experience in clinical research in the subspecialty of Hematology-Oncology preferred; Knowledge and experience in a Network research setting. Research certification preferred. Demonstrated experience with multi-study and multi-site clinical research activities. Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines. Demonstrated knowledge of FDA and Sponsor regulatory requirements. Knowledgeable of FDA and QA audit processes. Demonstrated familiarity with the requirements for network and Sponsor study and regulatory documentation. Required knowledge of Microsoft Word, Excel, PowerPoint, Outlook, Internet Explorer, and FileMaker Pro. Working knowledge of good clinical practices for clinical research Hematology-Oncology. Ability to work efficiently and complete tasks with a high degree of accuracy. Ability to organize multiple projects for efficiency and cost-effectiveness. Analytical skills sufficient to work and solve problems 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 in handling work delegated by more than one individual. Strong interpersonal communication skills to effectively and diplomatically interact with others. Strong written communication skills, ability to compose correspondence and maintain large file system. Typing and computer skill/ability including word-processing, use of spreadsheets, e-mail and data entry into clinical trails and Network database (MAC, PC, WORD, WORD PERFECT, EXCEL, MIRCOSOFT). Sufficient computer and computer networking knowledge to problem solve common hardware and software problems for novice users via the telephone. Ability to handle confidential material with judgement and discretion. Working knowledge of Institutional Review Board, Internal Scientific Peer Review Committee, Contracts and Grants and CRU policies and procedures. Sufficient math ability and knowledge of clinical trails budgeting process to assist with the preparation of clinical trial budgets. Skill in coordinating diverse, complex tasks and information transfer among administrators, staff, and Network physicians and on site investigators.



Complete Application