Senior CRA

Duties and Responsibilities
  • Participates in the development of the overall clinical plan, draft protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies.
  • Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.
  • Assists in the identification of centralised services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities, and participates in final selection.
  • Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
  • Conducts clinical site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multi-centre investigator meetings and prepares reports.
  • Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with regulatory regulations, guidelines and policies and ICH GCP.
  • Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.
  • Ensures appropriate transmission of clinical case data to the data management centres; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.
  • Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
  • Performs miscellaneous job-related duties as assigned.
  • Senior/Lead CRA: Working independently drive study activities, overseeing other project CRAs.
Qualifications:
  • Science degree or a nursing qualification.
  • Completion of nationally recognized formal CRA training.
  • Knowledge of randomised controlled clinical trials principles, methodology, and procedures.
  • Knowledge of European regulations and guidelines pertaining to the conduct of clinical trials on human subjects.
  • Knowledge of statistical data collection, editing, validation, and analysis techniques.
  • Knowledge of current and developing trends and standards in clinical trials monitoring.
  • Knowledge of industrial standards as applied to good clinical practices.
  • Knowledge of laboratory certification standards and processes.
  • Knowledge of the infrastructure and operational characteristics of centralised clinical laboratories.
  • Ability to independently develop novel concepts and techniques in clinical research monitoring.
  • Ability to develop and deliver presentations.
  • Ability to make evaluative judgments.
  • Ability to develop and implement clinical research monitoring plans and standard operating procedures.
  • Knowledge of patient care charts and patient histories.
  • Ability to establish data collection and management guidelines.
  • Ability to provide technical advice, guidance, and support to professional staff in area of specialty.
  • Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.
  • Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards.
  • Knowledge of database concepts, and formats.
  • Skill in the use of computer statistical, technical, and database applications.
  • Ability to develop technical reports and manuscripts.
  • Ability to monitor in non-English speaking countries.
Please click the link below and attach your CV and covering letter.
Micron Research will not be accepting resumes from Third Party Vendors.