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Feasibility Analyst

Company: Catalyst Clinical Research Llc
Location: Raleigh
Posted on: January 16, 2022

Job Description:

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 ready.

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.

Position Accountabilities/Responsibilities:

  • 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 feasibility assessments.
  • 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 required.
  • 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 contract.
  • 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 information.
  • 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 identification.

    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).

    Required Skills:
    • Clinical trials support and/or pharmaceutical industry experience preferred.
    • 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 platforms.
    • Ability to research and review scientific literature, study reports, medical journals to identify and represent current clinical trial landscape considerations in verbal and written format.
    • Proficient with Microsoft Office Suite.
    • Excellent written and oral communication skills.
    • Excellent presentation skills.
    • Strong organizational, problem-solving, and analytical skills.
    • 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 deadlines.
    • 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 and committees.
    • Good judgement with the ability to make timely and sound decisions.

      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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