Last Updated: November 16, 2017
The Site Contract Administrator is responsible and accountable for creating project-specific CDA, site budget and contract templates and develop Sponsor-specific contract negotiation guidelines and budget parameters, negotiate and track status of site budgets and contracts on behalf of Baim Institute and Sponsors, in accordance to Baim Institute’s Standard Operating Procedures (SOPs) and Work Instructions, Regional Regulatory Authority Guidelines and ICH/GCPs. Mentor staff and provide contract and budget negotiation guidance to teams. Provide site payment estimates for inclusion in new business proposals, in accordance with specified timelines. Work closely with SM Lead, or designated lead, Site Management team members, Site Management Management, Business Development, and Project Management.
Primary Duties and Responsibilities:
- Lead, coordinate and/or perform site level budget and contract negotiations:
- Liaise with Baim Institute Counsel and Sponsor to develop project-specific CDA, Site contract template and negotiation parameters.
- Negotiate site CDA, budgets and contracts in accordance to project parameters and local requirements.
- Work with SM Lead and Site Management team to negotiate and finalize budgets and contracts within agreed study start up timelines.
- Ability to prioritize review of CDAs, Contracts, and budgets in coordination with Site Management
- Ensure accuracy and consistency with all budgets and ensure appropriate formatting and figures.
- Coordinate and finalize site budget and/or contract amendments in a timely manner.
- Serve as the main point of contact for budget and contract negotiations with Sites.
- Provide project teams and Sponsor with budget and contract status updates, including process, timelines, metrics, and issues, as required.
- Update, maintain, and report from the Clinical Trial Management System (CTMS) during SSU or amendment phase to ensure current and accurate, in accordance to role expectations:
- Contract and Budget Status
- Site Contact Information
- Phone Contacts
- Identify contract/budget trends and bottlenecks. Present and implement solutions.
- Assist and coach Site Management staffing personnel on contract and budget negotiation process, tracking, and site budgeting questions, matters and issues.
- Provide site payment estimates for inclusion in new business proposals, in accordance with specified timelines.
- May be called upon to join departmental and/or company committees, such as SOPs development or review and update current SOPs or training materials.
- Demonstrate high knowledge of Clinical Research, Clinical Research Contractual Terminology, internal SOP’s, FDA/ICH guidelines to GCP’s and regulatory compliance.
- Effectively demonstrate the ability to negotiate contracts and budgets, prioritize, multi-task, complete tasks
- Demonstrate leadership skills, ability to lead and guide team members.
- Effectively work independently at a high level and in a team environment.
- High level of attention to detail and work in an organized manner.
- Ability to work in a fast pace environment.
- Proactively identify trends, present and effectively implement recommendations to SM and PM.
- Seek supervisory/other assistance when appropriate.
- Demonstrate the ability to complete tasks in an accurate and timely manner.
- Proficient with common software packages (Word, Excel, PowerPoint, Outlook) and Internet use.
- Knowledgeable with a CTMS.
- Ability to quickly learn new software packages.
Yrs. of related experience:
Required: 3-4 years of clinical contracting experience with pharmaceutical, biotech, or medical device companies