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Executive Assistant

Company University of Utah
Location Salt Lake City, UT
Update 5 Day ago
300
Provides direct administrative support for Huntsman Cancer Institute’s Research Compliance Office.

Responsibilities
RESEARCH COMPLIANCE OFFICE EXECUTIVE ASSISTANT and GCPs
(documenting position qualifies as ‘Clinical Research Professional’ per SoCRA)

Huntsman Cancer Institute’s Research Compliance Office was established to assist Principal Investigators of Investigator-initiated Trials with their sponsor-related GCP and regulatory requirements. These include:
• Coordinating and supporting the Data and Safety Monitoring Committee ( DSMC )
• Coordinating and supporting the Institutional Protocol Development Committee ( IPDC )
• Several CRO functions: protocol writing, project management, monitoring and auditing, data validation, manuscript writing support
• Standard Operating Procedure ( SOP ) writing, maintenance, and training coordination

Over 80% of the Executive Assistant’s duties in the Research Compliance Office include coordinating the IPDC , coordinating the DSMC , coordinating monitoring/auditing, and SOP quality control and training coordination. Outlined below are the specific GCP Principles and the Executive Assistant’s duties in which they are applied.

DSMC SUPPORT AND COORDINATION (35%)
• DSMC monthly meeting coordination – see the DSMC Meeting Operations Manual
• Preparation of agendas, materials, minutes, PI review letters, and other correspondence
• Tracking and following-up on meeting action items
• Tracking and obtaining annual COI forms and signatures
• SAE OnCore data entry

IIT AUDIT & MONITORING COORDINATION (20%)
• Scheduling and tracking for audits and monitoring visits
• Record keeping for audits and monitoring visits
• Communicating audit and monitor requests, meetings, and reports to PIs and study staff
• Monitoring and auditing binder preparation and maintenance
• Preparation and shipping specimen kits for external sites

IPDC SUPPORT AND COORDINATION (10%)
• IPDC monthly meeting coordination
• Preparation of agendas, materials, minutes, IPDC decision letters, and other correspondence
• Tracking and following-up on meeting action items

ADMINISTRATIVE (15%)
• Oversee RCO daily program operations and coordinate program activities
• Assist Research Compliance Office Manager and Officers
• Manage calendaring requests for RCO
• Prepare RCO staff meeting agendas and minutes
• Prepare RCO quarterly statistics for CREC meeting
• Coordinate RCO Travel
• Purchasing for RCO
• Process RCO SoCRA certification application and renewals
• Coordinate move requests including phone setup, computer move setup, etc when necessary

SOPs and WPDs (10%)
• Final SOP and WPD quality review
• Communicating SOP training requirements to CTO
• Tracking SOP training, reminders, updates
• Maintaining and updating SOP Excel spreadsheets
• SOP binder maintenance
• When CTO SharePoint portal is built, convert SOPs from X drive to SharePoint

CTEP / NCI INVESTIGATOR REGISTRATION – see SOP REG 44-10 (5%)
• Process new and renewal investigator registration forms

PROFESSIONAL DEVELOPMENT (5%)
• Relevant RATS classes
• Work towards SoCRA and/or ACRP certification

GCP Principles:
5.4.1 The sponsor should utilize qualified individuals (e.g., biostatisticians, clinical pharmacologists, and physicians) as appropriate, throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial/study reports.

Administrative Program Coordinator’s Duties
Investigator-Initiated trials ( IIT ) [also known as Sponsor-Investigator trials] require an initial review by the Institutional Protocol Development Committee ( IPDC ) before moving forward for full protocol development by HCI Research Compliance Office and support by the HCI Clinical Trials Office.
The purpose of the IPDC is to review all new investigator-initiated protocol concepts for completeness, feasibility, and optimization of HCI collaborations.

IPDC SUPPORT AND COORDINATION (10%)
• IPDC monthly meeting coordination
• Preparation of agendas, materials, minutes, IPDC decision letters, and other correspondence
• Tracking and following-up on meeting action items

GCP Principles:
5.5.2 The sponsor may consider establishing an independent data monitoring committee ( IDMC ) to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial. The IDMC should have written operating procedures and maintain written records of all its meetings.

5.16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies) of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB /IEC’s approval/favorable opinion to continue the trial.

Administrative Program Coordinator’s Duties
HCI DSMC COORDINATION (35%)
• Preparation of DSMC monthly meeting agenda, study data meeting materials, minutes, PI review/follow-up letters, and other correspondence
• Tracking and follow-up on PI and committee action items
• Tracking and obtaining annual COI forms and signatures
• SAE reporting at the DSMC meetings and eCRF (OnCore) data entry

GCP Principles:
5.18.3 Extent and Nature of Monitoring
The sponsor should ensure that the trials are adequately monitored. The sponsor should determine the appropriate extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial.

5.18.4 Monitor’s Responsibilities
The monitor(s), in accordance with the sponsor’s requirements, should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site:
(a) Acting as the main line of communication between the sponsor and the investigator.

5.18.6 Monitoring Report
(a) The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication.

Administrative Program Coordinator’s Duties:
IIT AUDIT & MONITORING COORDINATION (30%)
• Scheduling and tracking audits and monitoring visits
• Record keeping for audits and monitoring visits
• Communicating audit and monitor requests, meetings, and reports to PIs and study staff
• Monitoring and auditing binder preparation

GCP Principle:
5.1.1 The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP , and the applicable regulatory requirement(s).

Administrative Program Coordinator’s Duties:
SOPs and WPDs (10%)
• Final SOP and WPD quality review
• Communicating SOP training requirements to CTO staff
• Tracking SOP training, reminders, updates
• Maintaining and updating SOP tracking and training Excel spreadsheets
• SOP binder maintenance
• Ensure and maintain SOP version control

Minimum Qualifications
Bachelor’s degree in Business, Finance, Health Care Administration or a related field, or equivalency required. Two years office management and supervisory experience, demonstrated knowledge of finance and budgeting, and public relations skills required. Demonstrated human relations and effective communication skills are also required.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

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Type
Benefited Staff

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