Regional Clinical Research Associate, Oncology
ReSearch Pharmaceutical Services - St. Louis, MO

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The Regional Clinical Research Associate completes project activities associated with monitoring functions of Phase I-IV clinical research studies. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).

Responsibilities include (but are not limited to) :
  • Performs study start-up activities related to monitoring activities
  • Develops and implements innovative approaches for and participates in site recruitment, selection, and initiation activities
  • Participates in CRA protocol specific training and development activities
  • Develops and implements innovative approaches for the preparation and coordination of investigator meetings and participates in meeting
  • Conducts site initiation visits with study site staff (train site personnel in GCP and study conduct)
  • Develops patient enrollment strategies with the project team and clinical trial sites
  • Ensures the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines
  • Ensures proper storage, dispensation and accountability of clinical trial materials
  • Conducts interim monitoring visits (conducts source document verification of CRF against medical records)
  • Performs site management activities
  • Conducts in-house monitoring activities as appropriate
  • Review investigator regulatory files to ensure they are accurately maintained
  • Maintains patient tracking records for assigned sites
  • Conducts study site close-out visits
  • Completes administrative activities as a member of the project team
Qualifications :
  • Knowledge, Skills, and Abilities:
    • Excellent verbal and written communication skills
    • Excellent organizational, record retention, and time management skills
    • Excellent decision making skills
    • Excellent customer service and interpersonal skills
    • Knowledge of FDA regulatory requirements (i.e. GCPs, CFRs, etc.)
    • Passion for customer service
  • Education and Work Experience:
    • Bachelor’s Degree required in allied health fields such as Nursing, Pharmacy, or Health Science
    • Minimum 3 years of Oncology experience required
    • 4+ years of monitoring experience, with a solid medical/clinical background.
    • EDC and CTMS experience required

ReSearch Pharmaceutical Services - 11 months ago - save job - block
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About this company
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ReSearch Pharmaceutical Services (RPS) is a clinical research organization, and a little bit more. The Warburg Pincus-owned company manages...