Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

The Feasibility Site Specialist represents CRG in the global medical research community and is the main point of contact for potential investigative sites. Develops collaborative relationships with investigators and site personnel to conduct feasibility assessments. Ensures sites receive support and engagement and issues are resolved. Uses local knowledge, company systems, external sources including sponsor input to review and recommend site lists that are suitable for the strategic needs of the feasibility and to support the site development strategy. 

Essential Functions :  

Reports to a People Manager with the expectation of having a close collaboration with the local clinical operations management head, startup manager and Feasibility Manager (FM). 
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 is reflective of the defined site profile.
Proactively identify risks to quality and compliance and develop and implement mitigation plans to address these risks.  
Ensures current account, investigator and site staff contact details are appropriately maintained in company systems. 
Collect and document in real time all communication attempts and follow up associated with site contact and feasibility essential documents in applicable systems.
Responsible for primary investigator changes for the site in the system.
Reviews DPA/ISD status of each site and collects and tracks documents. 

Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked. Communicates with the sites to clarify any responses, as needed.  Updates applicable CRG system with appropriate questionnaire status.
Ensures an efficient, effective plan is in place for site contact and follow-up. Ensures compliance with the plan and escalates concerns to Feasibility Manager. Reviews with FM status of sites, at least weekly. 
May act as the local expert regarding site capacity and expertise. Work with key internal/external local personnel to gather knowledge base and recommend additional sites. Where applicable, develops and maintains relationships with client local affiliates.
May conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects. Further protocol and standard of care training would be provided.
Where applicable, conducts on-site feasibility visits. 
Collect data from sites around their capabilities such as but not limited to electronic medical records, remote source document verification and facilitate the required checks from a technology level with the required departments such as CRG IT. 
Education and Experience

Bachelors degree or equivalent and relevant formal academic / vocational qualification. 
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years’).
Previous experience as CRA or site facing position is desirable but not required
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, with the ability to communicate effectively with medical personnel and internal teams
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 local language as well as a good command of the English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic organizational and planning skills
Ability to attain and maintain a working knowledge of GCP and applicable SOPs
Ability to develop good customer focus
Proven flexibility and adaptability
Ability to work in a matrix environment
Ability to manage risk and perform risk escalation appropriately

PPD 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%). 

The salary range estimated for this position is $xxx,xxx - $xxx,xxx. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer. 

Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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