Sr CRA II | New Zealand
Inc Research, LLC
New Zealand
9d ago

Description

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator.

You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past.

Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-

deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Responsibilities :

  • Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
  • Documents the visit, and communicate findings. Recommends sites during the site feasibility and / or site selection process.

  • Conducts initiation visits in collaboration with other study team members and ancillary functional groups. Provides protocol specific and individualized training based on the Investigator and site personnel experience, prior to site activation under direction of Line Manager and / or Lead Monitor
  • Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan and best practices, protocol, ICH / GCP Guidelines and other local regulations as applicable
  • Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
  • Includes site monitoring activities for pharmacy, randomization review, drug accountability, and reconciliation of the blinded investigational products.

    Work with Unblinded study staff including pharmacists or Unblinded drug preparers and communicate only with internal Unblinded study personnel during the study conduct.

  • While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.
  • Identifies Key factors and the relative significance of a problem. Analyse root cause and potential bias. Seeks for appropriate input and creates a corrective and or / preventive action plan and communicate the process in a logical and timely manner and as discussed with a functional Monitor SME.

  • Performs site closure activities when all required protocol visits and follow-up are completed
  • Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and / or geographic territory.
  • Ensures quality of data submitted from study sites and assures data currency by using the available systems to follow site activities.
  • Clinical Data Listing review is performed at the assigned time points according to the Data Review Plan and / or SMP
  • Supervises overall activities of site personnel over whom there is no direct authority.
  • Motivates / influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method
  • Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team.
  • Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective / preventive actions based on root cause analysis are implemented

  • Involvement in Regulatory Compliance audit / inspection process, as needed. This includes the development and implementation of site corrective and preventive actions
  • Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
  • Builds, cultivates and maintains customer relationships and identifies synergies between customer needs and the company’s interests
  • Builds trusts with customers by serving as a consistent and accurate resource
  • Requirements :

  • Minimum of a Bachelors Degree within life sciences area or applicable scientific and / or clinical knowledge
  • Minimum 4-5 years' of monitoring experience
  • Experience monitoring in NZ
  • Experience in Oncology is required
  • Experience in planning and organizing multiple tasks. Work effectively in a dynamic environment with competing projects and deadlines.
  • Fluent in English (oral and written) communication skills
  • Proven ability to work as both part of a team and independently
  • Proven ability to overcome setbacks and obstacles
  • Disclaimer :

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

    Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

    The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

    Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms.

    Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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