Taiho Oncology

  • Clinical Research Associate

    Job Locations US-NJ-Princeton
    Category
    Clinical
    Type
    Regular Full-Time
  • Position Summary

    Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy.

     

    The incumbent assists Clinical Operations with the internal management of clinical studies, providing support for the planning, coordination, monitoring, tracking and general performance of clinical studies.  A critical component of the position is providing support to team members, assisting with site selection, monitoring, site communications and site management. In collaboration with the study manager oversees/coordinates the contract research organization personnel (CROs), consultants, contractors, and other colleagues to ensure quality is maintained on the studies for which the CRA is responsible.

    Responsibilities

    • Attends co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan, or as needed
    • Reviews Monitoring Visit Reports from the CRO
    • Monitors studies (PSV, SIV, IMV, COV) as needed
    • Escalates monitoring trends or findings to the Study Manager
    • Tracks metrics related to Sponsor Oversight and the Monitoring Plan
    • Assists in start-up activities of clinical research studies including Investigator Meetings, enrollment planning, and Investigator selection
    • Collaborates closely with study management, CRO study managers, and CRO monitoring staff, in reviewing site/patient activity tracking and preparing study updates
    • Regularly communicates with Investigators/site staff to identify and resolve  clinical study conduct issues and ensures site compliance with Good Clinical Practice, and federal and applicable local regulatory requirements
    • In collaboration with the CRO, guides investigative site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability
    • Reviews and provides input to study plans and guidelines, including study monitoring plans
    • Assists in the development of study documents, such as informed consent forms, study logs, and study manuals
    • Leads or assists with TMF processes, including set-up, training, QC, and management
    • Collaborates with CRO counterpart

    Qualifications

    Educational Requirements:   

    • Associates degree or equivalent.  Bachelors’ degree in in the biological sciences is preferred.    Requires a good understanding of medical terminology.

    Experience: 

    • 3 years clinical trial management experience in the pharmaceutical industry.
    • Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.
    • Has demonstrated knowledge of, and competence in, application of FDA/GCPIICH guidelines.

    Other Skills and Abilities:

    • Attention to details and well-organized.
    • Solution oriented and exceptional collaboration skills.
    • Must possess the ability to multi-task and effectively prioritize in order to ensure clinical trial goals.
    • Recognize potential obstacles and work to resolve them within set timelines.
    • Delivers work conscientiously and precisely even when under pressure.
    • A team player and able to work in a dynamic environment with attention to high quality results.
    • Excellent communication skills both verbal and written.
    • Good proofreading skills.
    • Takes initiative and utilizes good judgment.

    Language Skills:

    • Ability to effectively present information and respond to questions internally and externally.
    • Good proofreading skills.
    • Excellent verbal and written communication skills.

    Mathematical Skills:

    • Ability to work with mathematic concepts such as probabilities and statistics.
    • Ability to apply concepts such as proportions, fractions, percentages, to practical situations.

    Reasoning Ability:

    • Ability to collect information; define problems, establish facts, draw conclusions and propose feasible actions.

    Computer Skills:

    • Outstanding computer skills in Word, Excel, PowerPoint, and MS Project.
    • Prepares PowerPoint slide decks and other presentation materials for a variety of internal and external presentations.

    Physical Demands: 

    • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
    • The employee is occasionally required to walk.

    Work Environment: 

    • The noise level in the work environment is usually quiet.
    • Some travel is required.

     

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    The incumbent in this position may be required to perform other duties, as assigned.

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