Buenos Aires C.F.
A Central Monitor Assistant is a key skilled and clinically experienced team member of IQVIA Central Monitoring Department. A CM provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts.
- Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs, respective regulations and guidelines.
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.
- Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).
- May assist in Developing required basic data analytics scope and performing the trend analytics for their respective study(ies).
- Participate in (study) team meetings and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items.
- Escalate quality issues pertaining to site to respective Centralized monitoring lead/ Sr. Central Monitor.
- May perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review
- Interaction with sites/CRA and follow-up on study required milestones from the project start until close out.
- May act as backup/ perform the activities as per the task list delegated by Central Monitor Expert/Centralized Monitoring Lead MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- You must have a Bachelor's degree in life sciences or related field, or nursing qualification; or be near to obtain the degree.
- At least 2 years of relevant clinical research experience.
- Advanced English Level (mandatory)
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