Sr Feasibility Site Spec

Thermo Fisher Scientific

1d•Onsite

About The Position

The Senior Feasibility SL Specialist represents Thermo Fisher Scientific in the global medical research community. The role develops collaborative relationships with investigators and site personnel to conduct feasibility assessments in accordance with feasibility processes and deliverable timelines. The specialist builds local knowledge of research sites through collaboration with local Thermo Fisher personnel and uses that knowledge, company systems, external site lists, and sponsor directives to develop and review site lists that support feasibility strategy and local site tiering. The role also coordinates site contact and follow-up activities, reviews survey data, documents communications, and collaborates with Strategic Feasibility and clinical teams to achieve response goals and address site issues and risks. The specialist may lead assigned feasibility resources, serve as a local expert on site capacity and expertise, conduct physician and site personnel interviews, and, where applicable, conduct on-site feasibility visits in Asia Pacific. Additional work includes supporting global process development, training and mentoring teammates, strengthening Strategic Collaboration site networks, and contributing expertise on feasibility survey tools and systems.

Requirements

Bachelor’s degree in life sciences or a related field, or certification in a related allied health profession from an appropriately accredited institution (such as RN, MT, PA, RPh, or RT), or equivalent and relevant formal academic or vocational qualification.
Experience as a clinical research monitor, site study coordinator, research nurse, or feasibility specialist; alternatively, extensive experience as a research or project assistant providing the knowledge, skills, and abilities to perform the job. Typically, 2 or more years of experience are required.
Effective oral and written communication skills, including the ability to communicate effectively with medical personnel.
Excellent interpersonal skills.
Strong attention to detail and quality of documentation.
Good negotiation skills.
Good computer skills and the ability to learn appropriate software.
Fluency in the local language and a good command of English and grammar.
Good judgment and decision-making skills.
Basic medical, therapeutic-area, and medical terminology knowledge.
Ability to work in a team or independently with minimal supervision, as required.
Ability to mentor fellow SIA team members positively and effectively.
Strong teamwork and team-building skills.
Basic organizational and planning skills.
Excellent knowledge of local health systems.
Ability to attain and maintain working knowledge of GCP and applicable SOPs.
Excellent customer focus.
Flexibility and adaptability.
Ability to work in a matrix environment.
Relationship-building ability.
Independent thinking.
Ability to manage risk and escalate risks appropriately.

Responsibilities

Implement feasibility assessments.
Develop site lists using internal and external research to ensure they reflect the defined site profile.
Maintain current investigator and site staff contact details in company systems.
Complete the Site Interest Plan in CTMS and collect and deliver associated documents from investigators and site personnel.
Document all site-contact communications, attempts, follow-ups, and survey responses in real time.
Review survey data to ensure responses are logical, complete, and responsive to the questions asked.
Collaborate with the SF Specialist to achieve targeted response goals for assigned projects.
Communicate site issues and feasibility risks to the Strategic Feasibility team and appropriate SI&A and clinical personnel.
Serve as Lead FSLA when multiple resources are assigned to a project.
Coordinate site contact and follow-up plans, oversee assigned resources for compliance, and escalate performance concerns or non-compliance to the SF Specialist and SF Manager.
Serve as the local expert on site capacity and expertise, gather local knowledge, and recommend additional sites.
Use local knowledge when performing local site tiering.
Develop and maintain relationships with client local affiliates where applicable.
Promote the inclusion of Strategic Collaboration sites in the feasibility process.
Conduct scripted or non-scripted phone interviews with physicians and other site personnel to discuss standard of care and obtain protocol-level input for trial optimization projects.
Conduct on-site feasibility visits where applicable in Asia Pacific.
Liaise with Global Investigator Services to resolve investigator queries in real time and maintain account and contact information.
Contribute to the development and rollout of global strategic feasibility processes and best practices.
Train new FSLA team members on strategic feasibility processes and systems.
Mentor new teammates.
Use local knowledge to help identify and develop new Strategic Collaboration sites in the local market.
Collaborate with FSLAs in other regions to support consistent processes and sharing of best practices.
Serve as a subject matter expert on feasibility survey tools and provide input on future system and release development.
Expand therapeutic knowledge and expertise where the country structure permits therapeutic-area alignment.