RESPONSIBILITIES:
• The Supporting Clinician will provide medical and scientific study and project support for multiple, global, Phase 1-4 clinical studies in a clinical program.
• coordinating and leading the investigation process on all manufacturing and laboratory incidents related to all deviations including biomanufacturing process and equipment deviations and deviations for all analytical assays.
• protocol and study training
• Data review and interpretation
• study and/or program scientific and integrity oversight
• safety review and communication
• regulatory document, study report and publication preparation and review
• Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician
• Support the preparation of other clinical documents as required
• DATA REVIEW AND INTERPRETATION:
o Proactively coordinate with the Lead Clinician to assure understanding and agreement on deliverables
o Responsible for review of patient level data across a study and coordinating with Lead Clinician for study level review as delegated
o Study analysis and decision point preparation
o Interprets data and is able to identify issues of moderate/difficult complexity
o Conducts data review independently
• STUDY MEDICAL OVERSIGHT:
o Collaborates with the Lead Study Clinician(s) and COSTL to provide guidance during the execution of the study
o Provide input into the monitoring plan
• SAFETY:
o Ensure timely communication of safety issues
o Review and approval of subject narratives as delegated by the Lead Clinician
• REGULATORY AND PUBLICATIONS:
o Provide input, review and edit clinical study reports (CSR)
o Provide full review of content and integrates information from literature and other sources as appropriate
o Support and contribute to various sections of regulatory filings (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, and PSURs and Regulatory authority responses)
o Audit responses as delegated by the Lead Clinician
• CLINICAL PROGRAM IMPLEMENTATION:
o Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues
o Initiate and coordinate corrective action for major medical/safety/scientific study level issues
o Along with Lead Study Clinician(s) and COSTL and with regard to medical/safety concerns, ensures study level issues are resolved
o Collaborate with Lead Clinician and COSTL to arrive at major site level decisions based on input from the team
o Coordinates with Lead Study Clinician(s) and COSTL to maintain study timelines
o Along with the Lead Study Clinician(s) and COSTL and other study team members, participates in training of Study Management Staff and monitoring staff
o In collaboration with the Lead Study Clinician(s) and COSTL and study team, ensures the clinical trial material requirements of the study are met
o Ensure standard processes, tools, and procedures used consistently and globally
o Participates in developing training strategy for study with the study team members
Provide input into the preparation of study level training materials in collaboration with Lead Study Clinician(s) and COSTL and team members
o Ensures appropriate filing of documentation in the trial master file