Feasibility Site Specialist

6 months ago

Sydney, Australia Thermo Fisher Scientific Full time

Represents CRG in the global medical research community. Main point of contact for potential investigative sites through the feasibility process. Develops collaborative relationships with investigators and site personnel to conduct feasibility assessments in accordance with feasibility processes and within deliverable timelines. Ensures sites receive necessary support and engagement, issues are resolved. Utilizes local knowledge, CRG systems, external sources including sponsor input to develop and review site lists that are suitable for the strategic needs of the feasibility and to support the site development strategy.

Essential Functions and Other Job Information:

- Reports to a People Manager with the expectation of having a close collaboration with the local clinical operations management head 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 investigator and site staff contact details are appropriately maintained in CRG systems.
- Collect and document in real time all communication attempts and follow up associated with site contact and feasibility essential documents in applicable CRG systems.
- Responsible for primary investigator changes for the site in applicable CRG system.
- Reviews DPA/ISD status of each site and collects and tracks documents in applicable CRG system as needed.
- 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.
- Works to achieve targeted response goals for assigned projects. Communicates with the Strategic Feasibility team, appropriate local clinical team regarding site issues and feasibility risks.
- 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 local personnel to gather knowledge base 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 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.
- Contributes to the development and roll out of global strategic feasibility processes and best practices.
- Utilizes local knowledge to input into the identification and development of new sites within local market.
- Expands therapeutic knowledge and expertise to assist in review of local country site lists. Demonstrated knowledge of site intelligence at local level in support of site recommendation.
- 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.
- Assist Line Manager in developing agendas for team meetings.
- Assist Line Manager in recording team meetings.

Education and Experience:

- At a minimum, Associates 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’).

Knowledge, Skills and Abilities:

- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel and internal CRG 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
- Basic knowledge of local health systems
- 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 develop into a good relationship builder
- An independent thinker
- Ability to manage risk

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