Regional CRA with International CRO
ClinForce, LLC - Houston, TX

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We are an international CRO going through a major growth phase and we are looking to hire Clinical Research Associates in all therapeutic areas with at least two years of monitoring experience.

Responsibilities

  • Perform designated projects in accordance with applicable SOPs, clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.
  • Responsible for coordinating a moderate to large team or multiple small size protocols as the CRA, with minimal to no supervision. Alternatively, take on the role of a CRA on smaller projects.
  • Act as an independent CRA on complex or multiple projects, CRA on smaller projects
  • Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required. May represent company at professional meetings / conferences
  • Function as mentor and role model for other CRA team members to ensure study specific training for CRAs
  • Perform co-monitoring visits with less experienced CRAs or at problem sites as required
  • Build relationships with investigators and site staff
  • Participate in Investigator and other external or internal meetings as required
  • Arrange on-site visits and logistics (e.g. travel arrangements)
  • Perform on site visits in accordance with the monitoring plan
  • Perform site facilities inspection
  • Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
  • Monitor and maintain ICH-GCP compliance
  • Responsible for the completeness and quality of the on-site files
  • Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit
  • Update all relevant tracking system on an ongoing basis
  • Collaborate on site issues/actions
  • Generate visit/contact report in accordance with monitoring plan
  • Attend audits / Regulatory Inspection if requested
Requirements

  • Bachelor's degree (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
  • Substantial monitoring experience or equal experience in clinical research
  • Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
  • Strong regulatory knowledge including GCP
  • Excellent interpersonal, verbal and written communication skills
  • Sound problem solving skills
  • Ability to successfully work in a team environment
  • Sound presentation skills
  • Ability to solve problems by using a logical, systematic, sequential approach
  • Client focused approach to work with the ability to interact professionally within a client organization
  • Ability to prioritize multiple tasks and achieve project timelines
  • Effective time management in order to meet daily metrics or team objectives
  • Shows commitment to and performs consistently high quality work
  • Able to take initiative and work independently
  • Able to travel up to 65%-75% on average
  • Holds a driving license where required
  • Competent in written and oral English

Climber.com Catalyst - 2 years ago - save job