Senior Clinical Trials Officer

* Works with the Director, Research Contracting to establish consistent and high level of service provided to faculty researchers and administrators by Clinical Trials Team.
* Advanced knowledge of contracting and related processes.
* Demonstrated understanding of university research environment and policies.
* Drafts, negotiates, and comments upon complex clinical trial agreements, confidentiality agreements, and other sponsor contracts that may support clinical trial activities.
* Consults with initiative team members, faculty/researchers, and outside partners as needed on explanation of, and compliance with, University policies and practices as they relate to contract terms and conditions.
* Acting as part of the Contracts Team, independently manages various agreement types from initiation to completion/execution in a timely, efficient, and thorough manner.
* Communicates clearly and consistently with stakeholders during the negotiation process.
* Works closely and collaboratively with University Leadership support of faculty and various University needs.
* Works with colleagues and Associate Vice President for Research Administration to develop approaches and solutions for novel or atypical terms requested by faculty or potential sponsor.
* Maintains knowledge of current trends and developments in the field by attending professional development training, workshops, seminars and conferences and by reading professional literature in the related technical field.
* Has delegated authorization to sign agreements on behalf of the University under delegations authorized by the Associate Vice President for Research Administration.
* Provides faculty and administrators with application preparation, analyzing possible solutions to problems that arise using standard procedures. Reviews, interprets, and negotiates contract and grant terms to determine compliance and/or conflict with federal regulations and procedures.
* With limited guidance, helps to obtain sponsor approvals for major changes to project work scope, etc. Transmits proposals and manages post award administration, gathers and submits closeout documentation, and maintains records. Ensures completeness and accuracy and coordinates any internal controls prior to the submission of documents to awarding agency.
* Performs other related work as needed.
* Paralegal or legal experience.
* At least five years experience working in a university contracts-management environment, law firm, or in-house legal department or at least seven years of relevant experience drafting complex research or commercial agreements.
* Demonstrated experience in the management and/or negotiation of complex contracts.
* Proven ability to grasp complex legal and business issues.
* Proven ability to work effectively in support of business development and/or research administration and health care professionals.
* Familiarity with intellectual property concepts and federal laws and regulations as well as NIH guidelines pertaining to Clinical Research.
* Knowledge of academic research principles and research integrity policy (Conflict of Interest, IRB, IACUC, etc.).
* Knowledge of intellectual property law (copyright, patent).
* Comfortable with scientific concepts and terminology; able to understand the significance of various agreement terms in view of the nature of the materials/confidential information to be transferred and proposed research.
* Independence:
Work independently with a high degree of initiative, curiosity and minimal supervision. Willingness to learn new skills, take on new challenges, and ability to effectively interact and collaborate with all levels of university administrators and faculty members. Make decisions independently that will have downstream impacts on the management of sponsored projects.
* Communication

Skills:

Excellent oral and written communication skills with the ability to interact effectively with a diverse range of stakeholders, with faculty and administrative staff at the University, and close collaboration with all staff within the office of University Research Administration.
* Service Orientation:
Positive, service-oriented attitude with a courteous demeanor, maintaining professionalism in all interactions. Ability to develop and manage interpersonal relationships.
* Discretion and Confidentiality:
Ability to handle sensitive and confidential situations with absolute discretion and maintain confidentiality.
* Attention to Detail and Accuracy:
Exceptional attention to detail and thoroughness in completing tasks accurately. Work on multiple projects simultaneously, set priorities, and meet deadlines.
* Organizational and Multitasking

Skills:

Strong organizational skills with the ability to multitask, meet deadlines, and navigate ambiguity in a fast-paced work environment. Interact by phone, email, online meetings or in person with faculty and administrative staff at the University and occasionally with staff of federal government, non-federal sponsors, and other…