Gaining an overall understanding of clinical research and drug development including but not limited to Good Clinical Practices (GCPs), International Conference of Harmony (ICH) guidelines, and Standard Operating Procedures (SOPs)
Assisting with the management of trial activities including patient tracking through the screening process, and eligibility/ enrollment reviews
Assisting with document processing and management within the electronic master file (i.e., vTMF)
Participating in department and team meetings
Participating in cross-functional team and clinical team meetings
Developing study training materials/documents
Shadowing key clinical and or functional roles for learning/development opportunities
Observing Site Initiation Visit (SIV) Meetings
Supporting Clinical Team with study start-up activities during the trial set up, and other study tasks during conduct, and close out.
Assisting with the review and cleaning of clinical data (i.e., medical review), query generation, and resolution.
Assisting with interpretation, reporting, and preparation of oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions.
Reviewing medical literature, related products, and new technologies.
Providing necessary training to the local operational teams.
Collaboration and/ or assigned projects from other various functional disciplines.
Leadership opportunities on specific program and/ or group projects.
Abstract/ poster preparation and presentation at an organization-wide research symposium
