As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Site Identification and Selection Associate, Remote - United States
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
The Site Identification & Selection Associate will oversee and ensure the successful delivery of global (end-to-end) site identification and selection (strategy, plans, activities, timelines, synthesis of site/investigator insights and presentation to study teams) at a program/study level in collaboration with the Feasibility Director/Lead. Enable study teams to conduct effective and ongoing delivery within timelines that contribute to operational planning / decisions resulting in predictable delivery for achieving R&D goals.
The Site Identification (ID) & Selection Associate, under the direction and guidance of the Feasibility Director/Lead, is responsible for site and investigator identification.
Assists in the evaluation of sites and investigators to make selection decisions based on a data-driven study strategy and details about the site and investigator.
Oversees the analysis of clinical trial intelligence data and its application to effectively identify sites in selected countries which complement study startup forecasts and study strategies.
Create and implement innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued site identification and selection processes.
Accountabilities
In coordination with the Feasibility Director/Lead, is accountable for defining, developing, and delivery of global site recommendations for each assigned study.
Ability to understand and translate protocol requirements to develop the ideal site profile, in collaboration with key cross-functional leads, especially the Feasibility Lead/Director. Mine relevant databases, available literature resources, etc. to identify the best suited sites for the study and proactively advocate for inclusion of strategic relationship sites with the project team, as appropriate.
Assist in the development of the Site Profile and Protocol Specific Site Requirements and Site Identification Questionnaire/ Feasibility Survey specific to each protocol.
Provides tracking and weekly reporting of site identification deliverables to the study team and CRO.
Attends project team meetings (OSR, SET, Feasibility, Regulatory, etc.) provides updates relevant to site ID and selection.
Collaborates with Feasibility Lead/Director and Study Start-up team members in relation to the site identification and selection strategy.
Drive delivery of selected sites to insure study milestones of First Site Active and First Subject In can be met.
Supports Feasibility Lead/Director in final selection of sites in collaboration with other Study Team members and CRO study representatives.
Ensure sites are notified of selection decision based on results of site level feasibility assessment.
May support the development and maintenance of the global investigator database and communication materials
Technical/Functional (Line) Expertise
Comprehensive understanding of the pharmaceutical industry and deep expertise in clinical drug development
Demonstrated experience in clinical operations and managing site identification and site feasibility processes
Demonstrated knowledge of government/international databases, open source databases or proprietary databases (e.g. PubMed/Medline, ClinicalTrials.gov, Citeline, DQS)
Demonstrated ability to form strong working relationships with other groups within the organization essential to high level performance in this position
Knowledge or FDA and ICH-GCP guidelines for conducting clinical research
Leadership
Demonstrated ability to work across functions, regions and cultures
Enterprise level leadership with the ability to inspire, motivate and drive results
Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
Proven skills as an effective team player who can engender credibility and confidence within and outside the company
Ability to distil complex issues and ideas down to simple comprehensible terms
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
Decision-making and Autonomy
Interaction
Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
Ability to effectively implement R&D’s partnership strategy
Ability to build strong partnerships and drive role clarity with other interfacing functions.
Innovation
Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
Comfortable challenging the status quo and bringing forward innovative solutions
Ability to take risks implementing innovative solutions, accelerating time to market
Complexity
Ability to work in a global ecosystem (internal and external) with a high degree of complexity
Breadth of knowledge required across therapeutic areas, indications, and/or modalities
Requirements:
BS degree or international equivalent required, in a life science preferred
At least 2 years of pharmaceutical industry (or similar) experience. Direct responsibility in site identification, feasibility, and/or managing the study start-up processes of clinical research studies at a sponsor or CRO is preferred.
Expertise with leading edge trial optimization vendors, tools, and methods.
Proficiency with software models, database structures, and Microsoft Office Suite applications.
Expertise in principles driving country/site identification desired.
Direct experience in the pharmaceutical industry or related field required.
Ability to strongly demonstrate, interpret, explain, represent, present and drive unbiased data insights into clinical trials operational planning.
Ability to work across several projects with specific and unique requirements, while providing attention to detail and high-quality work.
Ability to be flexible, adapt to change, work independently, as well as work as part of a team in a matrix environment.
US Pay Range: $75-95,000 USD
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.
#LI - Remote
Applications will be ongoing, there is no deadline.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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