Job Title: Feasibility Site Specialist
Job Location: Remote, India
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Country Approval Associate - Make an Impact at the Forefront of Innovation
When you join the team at Thermo Fisher Scientific, you will do meaningful work that makes a positive impact on a global scale. Join 130,000 colleagues who bring our mission to life every single day, to enable our customers to make the world healthier, cleaner, and safer.
The PPD™ clinical research business of Thermo Fisher Scientific is a leading provider of global Clinical Research solutions. We provide clinical drug development, laboratory services and lifecycle services to pharmaceutical, biotechnology, medical device, academic and government customers. By harnessing innovative technology and expertise, we work to empower our customers to bring therapies to market faster.
The Feasibility Site Specialist (FSS) represents Thermo Fisher Scientific in the global medical research community and is the main point of contact for potential investigative sites. This role develops relationships with investigators and site personnel to conduct feasibility assessments and ensures sites receive support and issue resolution, through the feasibility process. Using local knowledge, company systems, external sources and sponsor input, the FSS will review and recommend site lists and conduct pre-award outreaches, that are suitable for the needs of the study. Reports into the Feasibility People Manager.
Essential Functions:
Gathers feasibility data and contributes to local site list vetting, Pre-award site outreaches, using approved internal tools and external sources to ensure the site list is specific to assigned study indication)
Reviews Confidential Disclosure Agreements (CDAs) and site survey data to ensure accuracy, completeness, and consistency, and follows up with investigative sites to resolve discrepancies or missing information
Coordinates and manages feasibility site document collection and tracking to support study milestones and deliverables, ensuring timely completion, data accuracy, and adherence to quality and compliance requirements
Ensures site and database contact information is current and accurately documents all communication attempts with sites.
May conduct phone interviews with physicians and other site personnel to discuss standard of care and obtain protocol-level input.
Where applicable, conduct onsite feasibility visits.
May support or participate in client calls and address specific client requirements related to site feasibility communications, as required for the study and at the direction of functional leadership or the People Manager (PeM)
Participates in Regional/country team meeting and proactively contributes on best practices and lessons learnt
Support and onboards new employees
May contribute to development and testing of electronic survey/feasibility tools
Supports adoption and implementation of new processes in department
Identifies and proactively escalates risks related to systems/feasibility processes and supports any mitigation planning
Maintains required knowledge of and ongoing compliance with all applicable systems, tools and procedures
Establishes and maintains collaborative relationships with investigative sites and site networks to facilitate study start-up, site engagement, and ongoing site support
Develops local intelligence and may act as a local expert regarding site capacity and expertise. Works with key personnel to gather knowledge and recommend additional sites.
Collaborates with study and country team stakeholders' example, Country Head, startup manager and Feasibility Manager (FM) on assigned studies.
Adheres to assigned goals and performance objectives and completes all required training and compliance activities within established timelines
Education and Experience:
Bachelor’s degree or equivalent and relevant formal academic / vocational qualification.
Previous feasibility and clinical research experience which provides the knowledge, skills, and abilities to perform the job (0-2 years)
Previous experience as CRA or site facing position is preferred
In some cases, an equivalency, consisting of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:
Effective oral and written communication skills, including medical terminology
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills (Microsoft Office) and the ability to learn appropriate software
Fluency in local language as well as a good command of the English language and grammar skills
Ability to work in a team or matrix environment or independently, under direction
Basic organizational and planning skills
Ability to attain and maintain a working knowledge of GCP and applicable SOPs
Proven flexibility and adaptability
Ability to manage risk and perform risk escalation appropriately
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require as-needed travel (0-20%).
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