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Clinical Research Associate (CRA)

Full Time
Ray - 
Giza, EgyptPosted 3 years ago
139Applicants for1 open position
  • 9Viewed
  • 0In Consideration
  • 0Not Selected
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Job Description

The CRA will be responsible for clinical site management including monitoring to fully ensure patient safety, verification of source data versus Case Report Forms (CRFs) to ensure accuracy and completeness of data in compliance with protocol (s), Federal regulations, ICH & GCPs. Helps to ensure that the quality of work and data are suitable to support New Drug Applications (NDAs).

  • Responsible for the management of clinical trials including investigator selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, Case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing trial related regulatory submissions with follow-up to ensure successful outcome.
  • Organize investigator’s start-up meeting and study site initiation meetings.
  • Ensure that proper drug accountability is maintained in assigned clinical trials sites.
  • Verify all data entries on case report form with source documents.
  • Responsible for prompt reporting and follow-up on all adverse experiences, as required by Protocol, Applicable Regulations and SOPs.
  • Monitoring the assigned clinical trial in accordance with Protocol, Monitoring Plan         (if applicable) and SOPs.
  • Planning the requirements for clinical trial materials, ordering clinical trial materials [CTMs] (From Sponsor) setting up and monitoring the systems whereby the Monitor Team can ship CTMs to the investigator, maintaining procedures to account for the CTMs, checking the expiration dates of CTMs and requesting extensions if necessary.
  • Keep the study trial master files up to date for all assigned projects to ensure compliance with local, legal and ethical requirements for study conduct.
  • Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly sent to Data Management or entered into the database. Ensure that queries generated are responded to in a timely fashion.
  • Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigator brochure; protocols; case report forms instructions; consent documents; CTMs shipping orders; start-up 
    meeting attendance documentation; letters of agreement; lab reference ranges; all internal & external correspondences.
  • Administer protocol and study related trainings to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Ensure the quality and integrity of study site practices is compliant with the protocol and applicable regulations and SOPs. Escalate quality issues to Clinical Project Leader (CPL).
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
  • Manage patient recruitment strategies (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to PIs).
  • Closely working with the CPL, assuming responsibilities when required.
  • Participate in departmental planning sessions.
  • Provide management to the clinical trial assistants to ensure that their role and contribution is optimized when required.
  • Report Issues of Serious GCP non-compliance, misconduct and fraud as appropriate.

Job Requirements

  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Ability to solve problems by being flexible and open to multiple solutions without being rigid
  • Independently motivated, detail-oriented and good problem-solving ability
  • Excellent communication, writing and presentation skills
  • Strong multitasking skills with significant attention to detail
  • Ability to prioritize within a busy environment and produce work to meet tight deadlines 
  • Requires a Bachelor’s degree with at least 2 years of relevant clinical trials experience
  • Previous experience in managing ophthalmology studies
  • Knowledge of applicable clinical research regulatory requirements; including GCP and ICH guidelines
  • Knowledge of the national regulations for IMP importation
  • Background and experience in reviewing, analyzing and understanding clinical trial data and the resulting statistics

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