Senior Feasibility Specialist

Join The CTI Team•Covington, KY

9h•Hybrid

About The Position

Independently sources and analyzes data to develop site, country and investigator strategy or recommendations for proposals and post-award feasibility offerings. Responsibilities include compiling feasibility reports, presentations, questionnaires and feasibility site assessment based on internal metrics and investigator feedback on study design and logistics, as well as enrollment projection potential, worldwide.

Requirements

Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience.
At least 5 years relevant pharmaceutical or CRO Clinical Research experience.
Global experience.
Equivalent combination of education, training and experience.

Responsibilities

Advise project teams on all Feasibility activities and/or strategy for clinical studies.
Research and apply critical thinking and analysis on the information available for therapeutic area(s), regarding incidence, prevalence, standard of care, factors determining and influencing indication frequency and distribution, treatment trends, competing trials, etc. and to be able to clearly justify CTI recommendations on site, country or investigator.
Carry out database(s) and literature search(s) whenever required, in the case where this search has been completed, apply detailed analysis skills to identify suitable sites for the project in question.
Perform searches on Investigators by country or by specialty.
Perform analysis on past recruitment rates by indication/ country etc.
Provide metrics for RFIs/ Proposals, as required.
Provide metrics on Investigator Performance.
Provide quality oversight of project feasibility trackers across the department to ensure projects are meeting timelines and objectives and the trackers are kept up to date and are accurate.
Take any necessary action with the assigned feasibility specialist to update incorrect or missing information in real time.
Create/coordinate the development of site surveys/questionnaires to obtain key information (e.g., investigator feedback on projected enrollment, feasibility of the study, and site capabilities).
Review the protocol, seeks expertise from applicable supporting functions (Clinical Monitoring, TSL, Medical, CPM, Contracts, RASSUS, etc.), and finalizes draft for sponsor review, as required.
Works with CPM to obtain client approval of the study specific feasibility questionnaire, as needed.
Create online survey (e.g., Survey Monkey) based on the approved questionnaire to facilitate the collection of data in the most efficient manner.
Track responses of the survey results to compile information for decision making.
Oversee the site information collection process and assess and analyze compiled information to identify trends and site capabilities, to interpret data, write reports, and make actionable recommendations.
Conduct timely site follow-up on all aspects of the feasibility process to ensure due diligence follow up is occurring and provide excellent communication back to sites regarding project status.
Entry of feasibility and maintenance of key data into CTI feasibility database to ensure that the database is always up to date and can support predictability, randomizations, forecasting, and other key performance measures within assigned therapeutic areas.
Ensure predictability of performance targets are met/exceeded within assigned therapeutic areas as applicable.
Collaborate with CPM, RASSU, Clinical Monitoring, other interdepartmental team members and Clients to enable in the Study Start-Up process.
Recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Prepare, as applicable, the feasibility call script for each client call to ensure that all relevant and critical information will be obtained.
Lead Feasibility calls in all feasibility stand-alone awarded projects and effectively and efficiently moderate calls when the CPM team is involved.
Ensure proficiency and knowledge of therapeutic area expectations.
Organize all aspects of the feasibility calls with the sites to ensure that these calls run effectively.
Liaise with team members to understand budgets for the studies they are working on and are accountable for maintaining project activities within documented scope and budget.
Identifies out of scope activities to Feasibility Management, Project Manager and assures that such activities do not begin until the appropriate authorization is provided.
Prepare presentations independently and/or written reports, as required, and delivers to internal/external stakeholders in the determined forum (e.g., client or team meeting).
QC and QA of various study related Feasibility documents and reports.
Participates in intra- and inter-departmental meetings.
Attend internal and external study meetings and feasibility status reports for each site and country during study meetings.
Provide support and information for input into proposals and business development to help build project assumptions, budget, and timelines.
Represent the Feasibility Department in capabilities and bid defense presentations.
Represent the Feasibility Department in Client / internal kick off meetings.
Leads in training and development of junior feasibility staff and other CTI functional staff regarding feasibility processes.
Mentors junior feasibility staff.
Responsible for the implementation of the lessons learned process within CTI, especially process improvements, within documented timelines, to implement and analyze surveys, where appropriate.
Responsible for administration of CTI’s investigator database and Feasibility Management System
Develop relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPs.
Performs other duties as required.