Essential Job Duties:
Be a Subject Matter Expert (SME) in all areas of Site Initiation & Kit Inventory Center
Performs main functions of Site Initiation Center as needed, which includes but not limited to:
Organizes and prioritizes investigator lists to meet startup timeframes;
Loads and modifies the database with the method of report delivery, defines and loads alert
faxing, as well as defines the phone alert messages as defined in the SOW;
Performs quality check on database loading;
Compare the investigator list against the database, determine existing distribution codes and
loads the investigator information into the database;
Confirm information with investigator site by sending the loaded information to the site via fax
Resolve any discrepancies noted by the investigator site on returned faxes;
Research and resolved courier reports of incorrect site addresses;
Loads shipping documents and courier for each investigator.
Performs main functions of Kit Inventory Center as needed, which includes but not limited to:
Define and maintain the Kit Material Supply (KMS) system at project level according to
Statement of Work (SOW) and/or at site level as necessary;
Enter the work orders into the database, after reviewing any project specific limitations or
Adjust inventory of collection kits as reported by sites or due to project modifications;
Troubleshoot, resolve and inform PM of any complex kit supply issues;
Assists Investigator sites with researching resupply of collection kits and materials;
Review and research incoming orders from Investigator Support Team;
Adjust or customize the KMS system as needed to meet the needs of the investigator sites;
Assisting Technical Administrator (TA) with complex baggie kit instructions and other
Supports management of SIKIC by:
Distributing and assigning tasks evenly to SIKIC member on daily basis;
Reviews and feedbacks on Work Instructions (WI);
Assists in defining and implementing new procedures;
Assists in creating and updating work instructions as needed;
Assists in investigating and resolving CAIR’s and reportable issues;
Assists in Process Excellence projects to reduce kit supply issues;
Assists in training, mentoring new staff members and helps the management to monitor
Acts as liaison within Site Support Services team and between SIKIC and PM, KP&S, IT etc.
and may need to represent SIKIC in interdepartmental meetings and discussions.
Effective and timely adherence to management communications, meetings, and Standard
Operating Procedures (SOP).
Assists and supports management in the implementation of global processes and procedures.
Tracks and reports metrics as determined by management in the agreed timelines.
Document all service failures, resolve, and escalate to management when appropriate
resolution is incomplete.
Other duties as assigned by management
3 year in a relevant industry.
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