Job Overview
Managing assigned monitoring responsibilities (simple protocols/ non-protocol tasks) competently, in a timely manner and with quality.
Essential Functions
Under mínimal supervision perform centralized monitoring activities for the assigned projects which includes but is not limited to
On time completion of assigned role specific trainings (self-learning courses, instructor led training, acknowledgement of e-SOP/WI etc.) and related assessment Loading and updating the active databases with details of participating sites
Provisioning of access for Infosario Portal.
Ensuring on-time completion of documentation(s) that form a part of the regulatory dossier for kit shipment [Kit Contents Chart(KCC)/Packing List//Import Permit].
Monitoring on-time release of patient laboratory report by following up on the associated pending activity(ies) with related team(s).
Ensuring that documentation is available for all monitoring activities performed for real-time audit readiness
Participation in department/process improvement initiatives as applicable.
Qualifications
High School Diploma or equivalent Req
0 to 1 year.
Requires basic job knowledge of systems and procedures obtained through prior work experience or education.
Must be able to comply with all applicable standards as required by the company.
Demonstrated ability to handle multiple tasks.
Demonstrated ability of critical thinking and problem solving.
Robust written and verbal communication skills including positive command of English language.
Strong interpersonal, communication, organizational, and time management skills.
Demonstrated ability to work in a fast-paced, high stress setting highly desirable.
Ability to establish and maintain effective working relationships with coworkers and managers.