Clinical Research

Published:
May 22, 2025 – The Clinical Research Professional conducts and manages clinical trials to ensure compliance with regulatory guidelines and ethical standards. This position analyzes clinical data to evaluate treatment efficacy and monitor patient safety throughout the study. The individual also collaborates with cross-functional teams to develop protocols, submit documentation, and oversee study timelines.

• Protocol Documentation:
  Maintains current and accurate protocol documentation and notifies appropriate individuals of pertinent protocol changes.
• Issue Communication:
  Identifies and communicates important protocol and data management issues to appropriate individuals.
• Patient Registration:
  Verifies that patients have completed appropriate registration materials and maintains related records and information.
• Volunteer Instruction:
  Instructs volunteers on protocol requirements and explains procedures and consent forms.
• Documentation Completion:
  Ensures related documentation is properly completed.
• Protocol Compliance Monitoring:
  Ensures protocol compliance with intense monitoring of specific study requirements and schedules protocol-related treatment and tests.
• Clinical Duties:
  Performs specific clinical duties per the research study.
• Supply Management:
  Assists in ordering and maintaining research supplies.
• Documentation Maintenance:
  Prepares and maintains a variety of documentation in the assigned area of responsibility.
• Specimen Handling:
  Serves as a backup, collecting and delivering specimens for analysis using appropriate or specified equipment.
• Labeling and Form Completion:
  Ensures proper labeling and obtains pertinent clinical and protocol information on request forms.
• Patient Interaction:
  Frequently interacts with patients, families, visitors, physicians, and related clinical departments.

• Trial Management:
  Participate in trial feasibility process, start-up activities, initiation, monitoring, and closeout activities
• Project Responsibility:
  Take responsibility for specific tasks on projects, or act as the main contact on individual projects, if applicable
• Document Creation:
  Create and distribute study documents
• Supply Management:
  Initial and ongoing IMP and/or other study supplies management
• System Updating:
  Update relevant tracking systems on an ongoing basis
• Staff Records Maintenance:
  Maintain the site staff details
• Data Review:
  Perform regular reviews of data per data review/monitoring guidelines (e.g., CTMS, EDC, IVRS, etc.)
• Document Collection:
  Collect updated/amended regulatory/essential documents in collaboration with CRA II, CRA III, SCRA, or Regulatory Officer (RO)
• Recruitment Monitoring:
  Review the recruitment plan and enrolment updates
• Data Follow-up:
  Follow up with site personnel on data entry, query status, and SAEs
• Site Communication:
  Follow up on appropriate site-related questions
• Trip Reporting:
  Prepare accurate and timely trip reports
• Site Management:
  Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment, and understanding of study requirements
• Risk Escalation:
  Identifying and escalating potential risks and identifying retraining opportunities for site personnel
• CAPA Management:
  Prepare corrective and preventive (CAPA) plans for issues identified during monitoring activities and proactive follow-up of each CAPA until timely resolution
• File Maintenance:
  Maintain the study files and ensure that files are up-to-date and accurate

• Trial Conduct Management:
  Manage activities related to the conduct of pharmaceutical, biotechnology and medical device clinical trials.
• Regulatory Document Management:
  Manage and provide support services for the collection, review, maintenance and tracking of regulatory documents from clinical sites.
• Site Training Management:
  Manage the training of potential investigative sites
• Site Selection Management:
  Manage the site/investigator selection system/process.
• Site Support Coordination:
  Provide centralized site support,…