DESCRIPTION

The Office of Clinical Trials Administration (OCTA) has the delegated authority to negotiate and execute industry sponsored and funded clinical trial agreements at UCSD. The department provides comprehensive review and negotiation of human subjects research related agreements with industry to determine compliance with University policies and applicable regulatory requirements in support of clinical researchers and administrators. This position is located within the School of Medicine and is part of the UC San Diego Health Sciences organization which is a $1 billion dollar plus organization encompassing 16 departments (14 clinical, 2 basic sciences), 2 professional schools (School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences), 2 hospitals, and various other programs and units all dedicated towards fulfilling the Health Sciences missions of education, scientific research, clinical care, and community outreach. As a top-ranking, future oriented organization, we offer challenging career opportunities in a fast-paced and innovative environment. We are looking for top talent that possess the personal characteristics of integrity, strategic thinking, intellectual curiosity, collaboration, and teamwork.

Using intellectual property / technology licensing / transfer concepts, and other clinical research related concepts, applies organization policies and procedures and applicable regulations to resolve a variety of intellectual property / licensing / transfer / clinical research / clinical trial contracting issues. Works on problems and contracts of moderate scope where analysis of situations, contract language, or data requires a review of a variety of factors. Works under direction of higher-level officer where some interpretation of established work policies and procedures is required, and, at times deviation from standard work practices may be needed.

This position works closely with both UCSD researchers / administrators and external sponsors and their representatives. Provides excellent customer service and is proactive and resourceful in responding to inquires or resolving problems. The primary responsibility of this role is to negotiate clear, mutually agreeable, and compliant contract terms and conditions that accurately reflect the nature and scope of the proposed research activity. This must be done in a way that preserves the University’s relationship with the other party and is in alignment with the University’s principles and mission. This position will primarily negotiate confidentiality disclosure agreements and contract amendments, of varying complexity.

This position will also negotiate clinical trial agreements of low complexity, as needed (e.g. under a master, mirroring prior contract terms). The ideal candidate for this position will have some experience or exposure to redlining contracts using Microsoft Word Track Changes and Commenting functionality in a high volume, client/customer facing environment. In connection with redlining contracts, this position will monitor and document related contract issues, escalations, and required compliance reviews and approvals (e.g. Conflict of Interest, Institutional Review Board, Export Control). As a result, this person will have the ability to interpret and apply a variety of information and documents, including clinical protocols and clinical study budgets. Acts as a careful data / record steward and is mindful of data / record integrity and maintains an accurate and up-to-date electronic contract file.

This position may also assist with contract intake and award related duties, and other administrative tasks, as needed.

MINIMUM QUALIFICATIONS

• Six (6) years of related experience, education/training, OR a Bachelor’s degree in related area plus two (2) years of related experience/training.

• Working knowledge of and application of standard principles, theories and concepts such as laws, regulations, and practices pertaining to the protection and management of intellectual property, university technology transfer, and general scientific and / or technical skills in subject matter area. Working knowledge of or the ability to develop working knowledge of regulations related to clinical trials and human subjects research.

• Ability to market technology to industrial partners; knowledge of contracts and grants preferred. Working knowledge of or the ability to develop working knowledge of human subjects research policies, compliance requirements, and operations in a university, hospital, or similar setting preferred. Ability to (i) develop working knowledge in these areas and (ii) provide advice to UCSD faculty, staff, and research administrators on industry contracting standards and procedures.

• Demonstrated ability to interpret and apply laws, regulations, or written policies and procedures, and articulate or apply such effectively, in a written work product.

• Ability to read, understand, and interpret clinical protocols and other medical, technical, and financial information.

• Ability to read, understand, and interpret clinical trial budgets and related financial/payments language and administrative concepts. Ability to perform simple to moderately complex financial calculations, including the calculation of direct and indirect costs.

• Excellent attention to detail with strong writing, proofreading (editing, composition, spelling, grammar, punctuation), and organizational skills. Writing is clear, concise, logical, and grammatically correct. Strong skills in editing and formatting of documents.

• Expert computer skills (including a fast typing speed), with demonstrated experience using the Microsoft Suite of programs (Word, Excel, PowerPoint, Outlook), including experience with the track changes function in MS Word, familiarity with Adobe, and the ability to adeptly work in a paper free environment using electronic systems and databases.

• Demonstrated critical thinking and problem-solving skills. Ability to analyze situations, contract language, or data that requires the review of a variety of factors.

• Ability to communicate clearly and interact professionally with internal and external parties. Strong interpersonal skills.

PREFERRED QUALIFICATIONS

• Paralegal or some legal / contract / research education, training, or experience.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check.