Clinical Research Associate II

August 9, 2017 | San Diego, CA (USA) | Research & Development

The Sr. Clinical Research Associate is responsible for planning, executing and managing clinical studies.

Responsibilities include, but not limited to, the following:

  • Manages contract research organizations (CROs) to oversee projects and interactions with study site investigators.
  • Builds strong relationships with investigators and site personnel. Serves as liaison between sites and Sekisui Diagnostics.
  • Assures compliance of clinical studies with the protocol, Good Clinical Practice (GCP), all applicable regulatory requirements and standard operating procedures (SOPs).
  • Assists in the development of study documents and study-specific plans.
  • Conducts or oversees site selection, initiation, interim monitoring, and study closeout activities.
  • Ensures the clinical study is being conducted in accordance with the approved project plan.
  • Ensures adequate monitoring is conducted at clinical sites and appropriate resources are maintained during clinical studies.
  • Reviews study correspondence and monitoring visit reports.
  • Responsible for study enrollment tracking and monitors the collection of clinical data for quality and trending.
  • Monitors the progress of clinical activities and provides project updates and issues to internal Sekisui stakeholders.
  • Develops and manages study timelines; responsible for executing studies within agreed timelines.
  • Evaluates clinical data, ensures data is accurate and complete, and creates reports for presentations and submissions.
  • Responsible for the preparation and maintenance of the Trial Master File and for the management of files at a CRO.
  • Ensures the study files and sites are ready for inspection.
  • Participates in creating or improving departmental procedures.

Education / Experience:

  • Bachelor’s degree in a science or health care field.
  • A minimum of 5 years of clinical research experience in the medical device or in vitro diagnostic industry.

Skills:

  • Strong knowledge of Microsoft Office and project management software, including Microsoft Project.
  • Thorough knowledge of clinical trial databases.
  • Demonstrated ability to collaborate and work effectively within a cross-functional team.
  • Ability to manage and communicate effectively with CROs and vendors.
  • Strong attention to detail and accuracy.
  • Excellent written and oral communication skills.
  • Ability to take initiative, identify risks, and proactively resolve or elevate problems in a timely manner.
  • Ability to multi-task and must be able to work in a fast paced environment.
  • Thorough knowledge of FDA regulations and ICH-GCP.

Other Requirements:

  • Available to travel approximately 30-40%.

Thank you for your interest in this position. Only those Applicants selected for an interview will be contacted

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