Company: Catalyst Clinical Research Llc
Posted on: January 16, 2022
Catalyst Clinical Research is a niche provider of clinical
research services through two established solutions- Catalyst Flex
and Catalyst Oncology. Here at Catalyst Clinical Research we
provide support and services exclusively to biotech companies
because we know and understand the biotech environment. Our 15+
years of experience allow us to quickly grasp the evolving needs of
our clients so we can deliver the solutions essential to meet the
evolving needs and unexpected changes inherent in oncology
development. When protocols amend or emerging data suggest a
breakthrough straight from Phase I to registration, we are
Position Summary: The Feasibility Analyst is a key member of the
Clinical Development Operations, Central Site Services Team. This
individual is responsible for setting priorities for workload and
deliverables, ensuring collection of input from and coordination of
activities with all stakeholders in the feasibility process and
collating information with Catalysts experience to produce
recommendations for country and site selection strategies. This
role assures data source integrity, proper interpretation and
resulting strategy provided in feasibility proposals and reports.
This individual participates in internal meetings and may represent
Catalyst at bid defense opportunities.
- Collect and analyze metric-based global intelligence for
pre-award strategic clinical trial development.
- Research, compile and analyze therapeutic area(s) information
contained in the clinical protocol. This may include assessment of
any or all the following: global and regional incidence and
prevalence, standards of care, factors determining and influencing
indication frequency and distribution, study phase and design
considerations, treatment trends, competing trials, etc., and use
this information to provide an overall assessment of the
feasibility of the study plan.
- Responsible for recruitment rate & enrollment data
verification, country and site distribution development, proposal
text generation, meeting proposal timelines, and contributing
towards bid defense material for presentations and independent
- Review and research scientific literature using the internet,
medical publications, and internal resources to provide background
information and text for proposal submission.
- Study Review Review clinical protocols, study assumptions,
client information and study plans for US and global trials.
- Conduct independent standalone site outreach projects as
- Interact with site, clients, vendors and other functional areas
as secondary project contact for site issues and questions.
- Manage time and project requirements based on study
- Design site surveys/questionnaires to obtain key information
(e.g., investigator feedback on projected enrollment, feasibility
of the study, and site capabilities); may assist in the
identification/selection of study sites.
- Oversee the site information collection process and assess
compiled information for trends and site capabilities.
- Interface with consultants and partners to collaborate with
internal and external sources to gather and share feasibility
- Provide input to proposals and business development activities
to help build project assumptions, budget, and timelines.
- Present and explain feasibility analysis to BD/Clients,
including the process, recommendations, and rationale in verbally
and within written formats (e.g., MS Word or MS PowerPoint).
- Assist with the development, expansion, and maintenance of
resource library of therapeutically alignment materials for
organizational reference and educational purposes.
- Participate in post award study handover meetings with the
Central Site Services team members.
- Post award assistance with enrollment projections and site
Position Qualifications and Requirements:
Education: Masters or PhD in a scientific field (or comparable
advanced scientific/clinical degree, such as PharmD) is preferred
or equivalent work experience.
Experience: Prefer 3 years relevant experience in drug development
with 1 year experience in conducting at least one of the following:
pre-award feasibility, post-award site identification / site
selection / recruitment planning for global studies or have
exceeded performance in the role of Global Feasibility Associate
(minimum of 1 year) with strong experience in the functional role
of feasibility (pre-award).
- Clinical trials support and/or pharmaceutical industry
- Experience using external Clinical Trial Databases (e.g.,
Informa Citeline, TriNetX,), governmental, and public databases or
related experience with research databases.
- High data analysis competency and ability to develop and
implement complex models using MS Excel and standalone
- Ability to research and review scientific literature, study
reports, medical journals to identify and represent current
clinical trial landscape considerations in verbal and written
- Proficient with Microsoft Office Suite.
- Excellent written and oral communication skills.
- Excellent presentation skills.
- Strong organizational, problem-solving, and analytical
- Ability to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within
constantly changing priorities.
- Proven ability to handle multiple projects and meet
- Strong interpersonal skills.
- Ability to deal effectively with a diversity of individuals at
all organizational levels.
- Commitment to excellence and high standards.
- Creative, flexible, and innovative team player.
- Ability to work independently and as a member of various teams
- Good judgement with the ability to make timely and sound
Working Conditions: General office working conditions apply.
Employee may be office or home based.
Catalyst Clinical Research, LLC is an equal opportunity employer.
We celebrate diversity and are committed to creating an inclusive
environment for all employees.
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Keywords: Catalyst Clinical Research Llc, Raleigh , Feasibility Analyst, Professions , Raleigh, North Carolina
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