Regional Clinical Research Associate III, Rare Disease
ReSearch Pharmaceutical Services - Texas

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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 in allied health fields such as Nursing, Pharmacy, or Health Science
    • Must have 4+ years experience.
    • Must be able to handle multiple protocols and Therapeutic Areas
    • Proficient with EDC(Inform) CTMS(Impact)
    • Flexible for travel
    • Has completed all site visits from pre-study to close outs.

ReSearch Pharmaceutical Services - 16 months ago - save job - copy to clipboard
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...