Feasibility Site Specialist (FSS)

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office Location Type: [Information not provided] Salary: [Information not provided]

Position Overview

The Feasibility Site Specialist (FSS) serves as the primary representative of CRG within the global medical research community. This role is the main point of contact for potential investigative sites during the feasibility process. The FSS is responsible for developing collaborative relationships with investigators and site personnel to conduct feasibility assessments, adhering to established processes and timelines. This includes ensuring sites receive necessary support, proactively resolving issues, and utilizing local knowledge, CRG systems, and external sources (including sponsor input) to develop and review suitable site lists that align with strategic feasibility needs and support the site development strategy.

Responsibilities

• Initiates feasibility intelligence collection based on study needs.
• Assists in vetting local site lists, including research from internal and external sources, to ensure the site list reflects the defined site profile.
• Proactively identifies risks to quality and compliance and develops and implements mitigation plans.
• Ensures current investigator and site staff contact details are accurately maintained in CRG systems.
• Collects and documents in real-time all communication attempts and follow-ups associated with site contact and feasibility essential documents in applicable CRG systems.
• Responsible for managing primary investigator changes for sites in applicable CRG systems.
• Reviews DPA/ISD status of each site and collects and tracks necessary documents in applicable CRG systems.
• Supports the review of survey data to ensure responses are logical, complete, and relevant to the questions asked, clarifying responses with sites as needed.
• Updates applicable CRG systems with appropriate questionnaire status.
• Works to achieve targeted response goals for assigned projects.
• Communicates with the Strategic Feasibility team and appropriate local clinical teams regarding site issues and feasibility risks.
• Ensures an efficient and effective plan is in place for site contact and follow-up, ensuring compliance and escalating concerns to the Feasibility Manager.
• Reviews site status with the Feasibility Manager at least weekly.
• May act as the local expert regarding site capacity and expertise, working with key local personnel to gather knowledge and recommend additional sites.
• Where applicable, develops and maintains relationships with client local affiliates.
• Champions the inclusion of Strategic Collaboration sites into the feasibility process.
• May conduct phone interviews (scripted or non-scripted) with physicians and site personnel to discuss standard of care and obtain protocol-level input for trial optimization projects.
• Where applicable, conducts on-site visits.
• Contributes to the development and rollout of global strategic feasibility processes and best practices.
• Utilizes local knowledge to input into the identification and development of new sites within the local market.
• Expands therapeutic knowledge and expertise to assist in the review of local country site lists.
• Demonstrates knowledge of site intelligence at the local level to support site recommendations.
• Collects data from sites regarding their capabilities (e.g., electronic medical records, remote source document verification) and facilitates required technology checks with departments like CRG IT.
• Assists the Line Manager in developing agendas for team meetings.
• Assists the Line Manager in recording team meetings.

Requirements

• At a minimum, an Associate's degree or equivalent and relevant formal academic/vocational qualification.
• Previous [Information not provided]

Reporting Structure

• Reports to a People Manager.
• Expectation of close collaboration with the local clinical operations management head and Feasibility Manager (FM).

Company Information

• CRG