Clinical Contract Specialist

6 months ago

Norfolk, United States Eastern Virginia Medical School Full time

Overview:

The position will assist in reviewing and negotiating a high volume of clinical study agreements and related agreements/documents on behalf of EVMS. This position involves working with global partners, faculty, staff and General Counsel during the contracting process. Must be detailed-oriented, effective organizational and administrative skills, including superior attention to detail, and able to handle multiple projects in a deadline driven environment.

The incumbent in this position may be eligible for up to three days of telework in accordance to EVMS policy

Responsibilities:
  • Maintain a clinical contracts excel spreadsheet of industry sponsored, federal, state, corporate and private foundations that includes independent review, negotiating significant and unique contract requirements, special provisions, terms and conditions to ensure compliance with appropriate laws, and regulations including meeting the needs of EVMS policies and business procedures;
  • Independently and assist with recommendations with alternative agreement language.
  • Complete amendments for contracts and/or budget documents, as necessary.
  • Provide administrative support, critical education, communications, and act as liaison between Grants Accounting and Sponsored Programs.
  • Establish and maintain effective working relationships with physicians, department administrators, senior leaders, clinical operations, and other internal and external staff involved in the contracting process and support the development and updates of policies and process/SOP documents.
  • Assist with contract issues as appropriate and liaise between Legal, Risk Management, clinical teams, and other internal stakeholders to resolve such issues.
  • Responsible for communicating the Institution policies and procedures to research support staff and Principal Investigators.
  • Manage and assist with creating, issuing, and routing subcontracts/subagreements, modifications, confidentiality/nondisclosure agreements, and assist with clinical trial agreements as necessary.
  • Serve as backup to all of Sponsored Programs staff.
  • Perform other duties as assigned.


Qualifications:

Bachelors degree. Two (2) years of experience. Experience in a sponsored research, or industry environment is preferred. Additional education may substitute for required experience and additional related experience may substitute for required education. Must have the ability to read and understand contract terms, redline agreements and make decisions with a practical, business-minded approach to contract negotiation. Previous experience as a project manager or coordinating large projects is an asset.

JOB COMPETENCIES:

  • Ability to review and understand technical, medical and legal documents related to Clinical Trial Agreements;
  • Develop and assist with negotiating, planning, strategizing, mentoring, monitoring, scheduling, diplomacy, critiquing, analysis, and problem-solving skills;
  • Excellent written and verbal communication skills, including negotiation skills and knowledge of Clinical Trial Agreements to clearly and concisely present information;
  • Ability to use sound judgement that protects EVMSs best interest and satisfies strategic contracting objectives and to ensure all contract work is in compliance with legal requirements, administration specifications, and government regulations;
  • Excellent computer and internet skills including knowledge of MS- Office products such as Excel, Word, and Outlook.


Location : Location:
US-VA-Norfolk

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