Investigator Site Services Assistant
il y a 1 semaine
**Work Schedule**
Other
**Environmental Conditions**
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Responsibilities may include but are not limited to, provides support to most business units within the organization. Works closely with investigator sites regarding data discrepancies and or general study questions. Supports the overall performance, education, and escalation of study questions or data discrepancies of the sites on a study level. To help ensure execution of protocols are completed accurately and on time. Resolves issues that arise during specimen accessioning to ensure specimen logging is accurate. Uses tools provided to answer questions and ensure clean data at the earliest point in time. Places calls to the investigator sites delivery sponsor alerts, voice alert values, and any other critical values.
- Triages calls where necessary to appropriate individual/departments and follow through to resolution. Continually reviews exceptions to resolve so that the data is cleaned within the agreed timelines. - Resolves queries so that efficient and timely sample analysis is undertaken by the laboratory, so report turnaround time is met.
- Monitors and escalates site issues through the appropriate departments/people e.g. project management to resolve and report as soon as possible. Ensures that all site issues are communicated and followed up to resolution, primarily to site and monitor. Reviews site performance metrics to educate where needed or to report back to monitor or sponsor.
- Follows the specifications and scope of work to evaluate requests for any additional test(s) (test performed in protocol) to be added to a sample. Evaluates the request for out of protocol testing following Scope of work for study. Facilitates requests to the appropriate person. Informs the investigator site of the results or reasoning not to proceed.
- Coordinates and resolves issues with samples and requisition forms at time of accessioning to have the samples and visit details in the database and reported as soon as possible.
- Amends patient information supplied by sponsors, project managers or investigator site into site database. - Attends study meetings to discuss risk assessment for our department and or overall business concerns and reports back to the team about requirements. - Works with study PM team on the creation of the requisition forms to ensure visit and study collection requirements are captured.
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