Clinical Research Associate (CRA) II at Planet Group Waukegan, IL

Planet Group

Waukegan, ILFull-time

Behavioral Health Market Context

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Qualifications

  • •Bachelor's degree in science or relevant field of study
  • •5 years of site Management and Monitoring experience, which includes a period of 2-3 years of non-interventional trial and remote/logic check monitoring experience
  • •Note: both on-site and remote monitoring experience is required
  • •Neuroscience and pain management experience is a secondary preference
  • •Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations
  • •Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with deadlines
  • •Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity
  • •Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated
  • •Ability to use functional expertise and exercise good judgment
  • •Demonstrated business ethics and integrity
  • •7 more items(s)

Responsibilities

  • •Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research
  • •Provides timely, and complete monitoring reports including actions items and follow-up
  • •Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs) and business processes
  • •Overviews the overall activities of site personnel over whom there is no direct authority and motivates / influences them to meet study objectives
  • •Proactively manages the site and ensures action plans are put into place as needed to ensure compliance
  • •Ensures audit readiness at assigned sites
  • •Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events, if applicable, by site personnel
  • •Ensures safety and protection of study subjects through compliance with the study monitoring plan, SOPs, ICH Guidelines, and applicable regulations
  • •Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members
  • •Manages investigator payments as per executed contract obligations
  • •Manages site specific central IRB submissions and approval, including tracking
  • •Maintenance of site files with in the TMF
  • •Manages site specific updates to CTMS systems
  • •Site feasibility: at the direction of the study management team, evaluates and recommends new/potential investigators/sites on an on-going basis
  • •to assist in the placement of planned study with qualified investigators/sites
  • •12 more items(s)
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