CRA II - Texas

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring Responsibilities
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data
  • Ensure the resources of the Sponsor and Labcorp Drug Development are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp Drug Development travel policy
• Travel, including air travel, may be required and is an essential function of the job
• Prepare accurate and timely trip reports
• Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Labcorp Drug Development or client data management systems, as assigned by management
• Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
• Provide coverage for clinical contact telephone lines, as required
• Update, track and maintain study-specific trial management tools/systems
• Generate and track drug shipments and supplies, as needed
• Track and follow-up on serious adverse events as assigned
• Implement study-specific communication plan as assigned
• Attend investigators' meetings, project team meetings and teleconferences, as needed
• Assist Sr. CRA in managing investigator site budgets
• Perform other duties as assigned by management

Minimum Required:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)

and

• a minimum of 6 months of experience in a related role
• Ability to monitor study sites according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

Preferred:

One (1) or more additional years of experience with Phase 1 studies (as a Clinical Research Coordinator or as a CRA).

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