Site Contracts Specialist (Remote, United States)
Location: Morrisville, North Carolina, United States
Requisition Number: 997
Position Title: Specialist, Site Contracts
Site Activation is a fast growing, dynamic department! We are the launch pad for new projects. We help determine strategies for the optimal mix of countries, target sites and other factors to expedite regulatory and recruitment objectives, and then execute that strategy by initializing regulatory filings and locating, qualifying and activating clinical research sites.
The Site Activation group is the perfect place to launch or further your career. We emphasize development of project management and strategic planning skills that will advance you though the opportunities within Site Activation or serve as an excellent pathway to advancement in Project Management or other Clinical Operations groups.
The Site Contracts Specialist is responsible for the development, dissemination, negotiation and finalization of clinical study and investigator agreements and related documents between sponsors and clinical research sites.
- Drafting, reviewing and analyzing site, investigator and other project-related contracts
- Negotiation and finalization or assistance in negotiation and finalization of clinical trial contracts and services contracts with WCT Legal Department, study team, Sponsors, investigators and/or clinical sites, amending and terminating such contracts
- Development and negotiation or assistance in development and negotiation of new investigators/site contracts and/or country contract templates as well as addenda to them
- Manage execution (including signature process) of contracts with sites, investigators and other project-related contracts as applicable
- Reviewing study budgets and costs pertaining to contract negotiation
- Liaising with WCT Legal Department, study teams, sponsor, sites and investigators
- Representation of the Company in relations with clinical sites, investigators, other parties and project-related vendors, as applicable
- Performing legal translation and/or proofreading of contracts with clinical sites/investigators
- Develop, monitor, track and process new and amended investigator/site contracts and other project-related contracts.
- Review contracts and other documents for completeness and accuracy.
- Maintain and update hard-copy and electronic contract files.
- CTMS entry, maintenance and regular update as assigned
OTHER SKILLS AND ABILITIES:
- Excellent negotiation skills and knowledge of clinical trial agreements.
- Computer literacy and confidence in working with legislation databases, document, spreadsheet and other office software
- Bachelor's Degree or equivalent in business administration, finance, science or related field.
- At least 1 year of experience working with investigator/site contracts.
- Experience in Clinical Research Pharmaceutical or CRO industry.
- Knowledge of ICH CGP and local country legislation in the sphere of clinical trials
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Site Contracts Specialist (Remote, United States)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.