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)