CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, current and complete always throughout duration of the study.
Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and comonitoring visits. Visits can be conducted either onsite or remote as per CMP.
Responsible for learning the company culture, policies, and procedures through specialized training called CRA II fast track training program including observational visits for all types of visits (if applicable) and on the job training by supporting the day-to-day CRA activities of clinical project team members such as CRAs and Line managers (LMs).
Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs. Escalate all key issues as per Issue Escalation SOP.
Qualifications
At least 1 year of independent clinical monitoring experience
Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered.
Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.
