Sr. Site Selection Specialist

Job Overview:

The Sr. Site Selection Specialist will collaborate closely with Global Feasibility Leads, project management, clinical management, start up and Site Selection Lead for the coordination of high-quality feasibility and site identification assessments in the post-award space. They lead and participate in planning and development of any informational or system-related capabilities for site identification /feasibility/site selection, in order to continuously improve processes and outputs. Plan and participate in process development and change initiatives within FSS. Conduct and participate in training on departmental requirements and any other subjects that impact on feasibility or site identification conduct.

Summary of Responsibilities:

• Full/Partial ownership of the Feasibility/Site identification tasks in designated lead studies inclusive of but not limited to maintaining the site ID tools, running inconsistency checks, archiving emails at regular intervals.
• Provide support to Site selection lead for an oversight study by maintaining the site ID tools, CDA review, running inconsistency checks if agreed, archiving emails at regular intervals and extract bulk PDF using company software as previously agreed.
• Provide support to Site selection lead in their assigned tasks of site list development by performing inspection checks, past experience checks, Canada Opt in/out, Citeline data extraction as requested and setting up of site ID tracker.
• Create electronic surveys using company software not limited to study specific surveys and ad hoc electronic survey request. (E.g., Clinical Quality Control (CQC) visits, feedback, quiz, database of sites, Pre-screening logs etc.)
• Build scoring tool inclusive of Pre-Selection Visit or Risk Based Monitoring tool as needed.
• Engage is share drive cleaning at regular intervals. Independently run the automated dashboard as per schedule.
• Perform review of various tasks and provide feedback to site selection specialist inclusive of but not limited to electronic surveys, site ID tool builds, Inspection check and Citeline data extraction and provide feedback.
• Maintain master site list for allocated client/indication.
• Run and calculate Site ID monthly metrics every month using the trackers saved by site selection specialist.
• Lead, participate and review preparation of site selection curve/graph when streamlined.
• Review random Quickbase check clean up done by Site Selection Specialist.
• Responsible for setup and conduct for feasibility/site identification studies according to timeline and quality standards and client expectations.
• Conduct process related trainings to new team members joined as site selection specialist.
• Take on the mentorship role for new team members and report to line manager of progress.
• Learn and utilize the data sources available for site performance data.
• Plan and participate in internal planning meetings.
• Ensure accuracy and quality of survey data.
• Work with team and other Senior staff to identify potential risks and out of scope activity.
• Ensure site identification team in each country is entering and updating internal tracking tools for the studies assigned.
• Liaise with the global, cross-functional teams, inclusive of legal, start-up, clinical, country teams, and project management when needed.
• Support Investigator Intelligence database development and maintenance.
• Develop and deliver training of feasibility and site identification requirements/processes.
• Plan, lead and participate in the development, implementation, and maintenance of systems.
• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• Qualified candidate has an Associate’s degree with equivalent work experience or equivalent years’ relevant work experience.
• Fluent in English, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirementsc.

Experience (Minimum Required):

• Minimum of 4-5 years of full-time working experience, with minimum 1 year in the drug development or healthcare industry, working in some capacity with data related to investigators and/or clinical research institutions.
• Other required work-related experiences: Knowledge of ICH/GCP guidelines.
• Experience in protocol or site feasibility related to clinical research, in platforms used for protocol feasibility, site identification/selection with web-based surveys and with master data management a plus.
• Position-specific Requirements:
• Strong understanding of the feasibility, site identification, and selection for clinical trials.
• Clinical, start up, project management, or regulatory experience helpful.
• Strong writing and presentation skills.
• Upholds the highest standard of personal professionalism and work integrity.
• Demonstrated ability to work independently.
• Strong attention to detail/quality control skills.
• Ability to establish and maintain effective working relationships with team members, management, operations staff, clients, and executive management.
• Demonstrated ability to handle multiple competing priorities effectively.
• Negotiation and relationship management skills.
• Experience in analyzing study and investigator performance metrics.
• Self-motivated, works effectively under pressure.
• Technical Requirements:
• Strong computer skills, including strong working knowledge of Microsoft Office, Excel and other data capture and compilation tools.
• Experience with data manipulation, analysis, reporting and maintenance.
• Experience with investigator performance databases and CTMS a plus.
• Proven written and verbal communication skills.

Physical Demands/Work Environment:

• General Office Environment.
• Travel Requirement: 5% (Global) / Travel will likely be minimal; however, from time to time there will be a need to attend:
• Conferences, client meetings, vendor meetings.
• International and Domestic travel maybe required, including air travel and overnight stays.
• Will need the ability and willingness to present at internal and external meetings.

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