The Global Agreements Specialist is responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions.
Responsibilities include (but are not limited to) :
Responsible for drafting, negotiating, and finalizing Clinical Trial Agreements (CTAs) with sites as they relate to various clinical projects
Draft investigator grants according to sponsor's grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Utilize grant development databases (e.g., PICUS) as required.
Establish Master Service Agreements and standardized budget templates with frequently used sites.
Determine potential needs for contract amendments and manage amendment execution
Analyze clinical trial agreements and identify areas of concern and/or contention prior to obtaining formal legal counsel advice
Assure that contractual terms and provisions are in compliance with sponsor's process, systems, and strategies.
Escalate any site specific issues that do not comply with established guidelines for reviewing and approving both contractual language and investigational budgets
Act as liaison to legal counsel to resolve contractual/legal issues with sites
Assume responsibility for all aspects of document and metric tracking
Adhere to SOPs, ethics and departmental compliance as determined by sponsor management as well as corporate, HCC and QA guidelines
Contribute to improving processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites
Collaborate with other members of the Contracts and Grants team and contract consultants to ensure proper dissemination and management of knowledge and to meet team goals and objectives
Attend project team meetings on an as needed basis
Perform other duties as required
4 year degree
4 years experience handling site agreements
Excellent oral and written communication skills