Sponsor Dedicated CRA II

1 month ago

Bristol, Bristol, United Kingdom Pharmiweb Full time
About the Role

We are seeking a highly skilled and experienced Clinical Research Associate II to join our team as a Sponsor Dedicated CRA II. In this role, you will be responsible for conducting site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) compliance.

Key Responsibilities
  • Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) compliance.
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
  • Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
  • Conduct Source Document Review of appropriate site source documents and medical records.
  • Verify required clinical data entered in the case report form (CRF) is accurate and complete.
  • Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
  • Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
  • Verify site compliance with electronic data capture requirements.
  • Perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
  • Verify the IP has been dispensed and administered to subjects/patients according to the protocol.
  • Verify issues or risks associated with blinded or randomized information related to IP.
  • Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
  • Reconcile contents of the ISF with the Trial Master File (TMF).
  • Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
  • Support subject/patient recruitment, retention, and awareness strategies.
  • Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
Requirements
  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Strong monitoring experience gained from CRO/Pharma. Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Must demonstrate good computer skills and be able to embrace new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.

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