Clinical Research Associate

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Position Summary

 We are seeking a Clinical Research Analyst to become a part of our team! Under general supervision, reporting directly to VP of Clinical Research Operations. This position performs a supporting role in the financial and operational activities of the Clinical Research Department within the Houston Office

 

  • Key Responsibilities
        • Manage Essential Documents by evaluation of the conduct of a trial and the quality of the data generated and good documentation practices
        • Study Start-Up, assisting in feasibility assessment, site selection, pre-study visit, site initiation, subject recruitment and retention, trial master file (TMF) and clinical trials budgeting.
        • assist sites in adhering to FDA and other local and international regulations and/or guidelines
        • CRF review and source data verification, drug accountability and compliance, document archival and maintenance.
        • Safety Reporting and compliance for adverse event reporting
        • Be involved in study startup (if applicable)
        • Perform CRF review, source document verification and query resolution
        • Be responsible for site communication and management
        • Be a point of contact for in-house support services and vendors
        • Communicate with internal project teams regarding study progress
        • Participate in feasibility research
        • Support regulatory team in preparing documents for study submissions

     

Qualifications and Skills

  • 3-5 years of experience as a Clinical Research Associate
  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Experience in all types of monitoring visits in Phase II and/or III
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Valid driver’s license (if applicable)
  • Proficient computer skills.
  • Valid driver’s license with up-to-date insurance.
  • Excellent communication skills, using diplomacy and discretion.
  • Professional demeanor.
  • Excellent organizational skills.

 

Employment Type

  • Full-time
  • 401K, Dental, Life, Medical, Vision
  • At InGeneron Inc, Houston, TX

 

Please e-mail your resume to careers@ingeneron.com or contact us at any time if you have questions.