Job Details

Senior Contract Officer

Company name

UCLA Health System

Organization Type

In-House

Job Type

Legal Staff

Date Last Verified

Feb 11,2019

Valid Through

May 27,2019

Posted on

Feb 10,2019

Min Salary/Max Salary

USD 6667 to 13167 Annually

Location

Westwood, CA, United States

Employment Type

Full-time

Industry

Legal
Practice Area
Health Care >> Health Care
Litigation >> Litigation - Health Care
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Administrator/Coordinator/Officer
Candidate will work closely with the Chief Medical Officer for Clinical Research (CMO-CR) as well as the Director and Assistant Director of the CTC &SR to independently manage a contract portfolio with minimal supervision, and mentor junior CTC & SR team members. Industry clinical trial contract team are to identify upcoming studies as early on as possible and facilitate the processing of necessary regulatory submissions (including IRB and Financial Disclosures), budgets, and contract agreements, etc. in a proactive manner. Serving as a resource for investigators in communicating and trouble-shooting issues with the Office for the Protection of Research Subjects, Office of Research Policy and Compliance (oversees Conflict of Interest Review Committee [CIRC]), and other offices and departments involved in the clinical research pre-study process. Will establish a customer service relationship with faculty and staff involved in the conduct of clinical trials as well as pharmaceutical, biomedical and medical device companies. Requires expertise in industry clinical trial agreement drafting, negotiation and management, experience navigating policies and procedures, as well as a thorough understanding of all aspects of the required pre-award process steps for clinical trials research. Will be supervised by the Director of the CTC & SR, however is expected to work extremely independently often directly and in close collaboration with other Directors/Assistants Directors within OCR and the CMO-CR.

Qualification and Experience

Qualifications: Bachelor's Degree, required. Graduate degree, Juris Doctorate, Paralegal Degree with focus in contract management, or Master in Public Health or Master of Business Administration, preferred. Demonstrated expertise in negotiating industry supported clinical trials. Demonstrated expertise in industry clinical trial agreement drafting and negotiation. Strong working knowledge of the full range of pre-award activities related to clinical trials research (e.g., IRB, CIRC, Coverage Analysis, other regulatory approvals, etc.) Knowledge of pharmaceutical, biomedical, and/or medical device company research and development trends. Demonstrated mature clinical and independent administrative judgment and decision-making skills. 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. Demonstrated knowledge of industry contracting and subcontracting practices, including demonstrated experience in drafting contracts and subcontracts. Demonstrated excellence in negotiating skills, including the ability to resolve conflict among various groups and individuals with diverse backgrounds and goals concerning sensitive and important issues. Proven ability to participate effectively in the planning and development of multidisciplinary, cross-departmental research programs and committees. Ability to communicate effectively 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. Ability to be flexible and adapt within an ever-changing, dynamic, service-oriented environment. Ability to operate effectively in a team environment. Ability to set priorities of assignments to complete work in a timely manner when there are changes in workload, pressures of deadlines, competing requirements and changes in assignments. Skill in analyzing information, problems, situations, policies or procedures to define the problem, need or objective, identify relevant issues or concerns, formulate alternatives for resolution or new program development, and recommend alternative choices and implications for implementation.

Additional info

Job No.: H100113

Company info

Hiring coordinator
UCLA Health System
10920 Wilshire Blvd.
Suite 400
Los Angeles, CA 90095

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