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Sr. Cell And Gene Therapy CRA (Home-Based, West Coast) - IQVIA Biotech

  • Full-Time
  • San Diego, CA
  • IQVIA
  • Posted 3 years ago – Accepting applications
Job Description
Help create a healthier worldSTART RIGHT HERE AT IQVIA.BASIC FUNCTIONS:Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.KNOWLEDGE, SKILLS AND ABILITIES:
  • Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
  • Four+ years of oncology experience and/or medical device.
  • Experience in monitoring and/or coordinating clinical trials required.
  • Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
  • Demonstrated ability to form strong functional relationships.
  • Excellent, presentation, organizational and interpersonal skills.
  • Ability to interact with all levels of staff to coordinate/execute study activities.
  • Ability to handle several priorities within multiple, complex trials.
  • Ability to reason independently and recommend specific solutions in clinical settings.
  • Ability to work independently, prioritize, and work within a matrix team environment.
  • Ability to mentor other CRAs and co-monitor, as required.
  • Knowledge of electronic data capture including basic data processing functions.
  • Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
  • Able to qualify for a major credit card, rent an automobile
  • For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.
PHYSICAL REQUIREMENTS:
  • Very limited physical effort required to perform normal job duties
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
MINIMUM RECRUITMENT STANDARDS:
  • BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.
  • Prior Clinical Research Organization (CRO) experience preferred.
  • Prior project team leadership experience preferred.
  • Working knowledge of budget management preferred.
  • Must be able to travel domestically and internationally approximately 65%-85%.
  • Valid driver’s license
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
CLASSIFICATION (US):This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.


IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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