ICON Clinical Research, Inc.

Transcription

1 Training Proposal for: ICON Clinical Research, Inc. Agreement Number: ET Panel Meeting of: September 20, 2013 ETP Regional Office: San Francisco Bay Area Analyst: T. Teles PROJECT PROFILE Contract Attributes: Retrainee Priority Rate Industry Sector(s): Biotechnology/Life Sciences Services Counties Served: San Diego, San Francisco, Los Angeles Priority Industry: Yes No Repeat Contractor: Yes No Union(s): Yes No Number of Employees in: CA: 166 U.S.: 3,152 Worldwide: 8,915 Turnover Rate: 16% Managers/Supervisors: (% of total trainees) FUNDING DETAIL 11% Program Costs - (Substantial Contribution) (High Earner Reduction) = Total ETP Funding $172,800 $0 $0 $172,800 In-Kind Contribution: 100% of Total ETP Funding Required $592,914 ETP Single (08/16/12) 1 of 4

2 ICON Clinical Research, Inc. September 20, 2013 ET TRAINING PLAN TABLE Job No. Job Description 1 Retrainee Priority Rate Type of Training Business Skills, Commercial Skills, Computer Skills, Continuous Improvement, Management Skills Estimated Range of Average Post- No. of Hours Cost per Retention Trainees Class / CBT Trainee Wage Lab $1,080 $18.00 Weighted Avg: 60 Minimum Wage by County: $16.03 in San Francisco County; $16.00 in Los Angeles County; $15.45 in San Diego. Health Benefits: Yes No This is employer share of cost for healthcare premiums medical, dental, vision. Used to meet the Post-Retention Wage?: Yes No Maybe Although employer provides health benefits, they are not being used to meet Post-Retention Wage. Wage Range by Occupation Occupation Titles Wage Range Estimated # of Trainees Information Technology Staff 10 Information Tech. Staff Senior Level 6 Managers 18 Operations Level 1 24 Operations Level 2 8 Research Staff 29 Research Staff Senior Level 64 Support Staff 1 INTRODUCTION Founded in 1990, ICON Clinical Research, Inc. (ICON) ( is a wholly-owned subsidiary of ICON plc (Ireland). ICON offers a broad range of specialized services to assist pharmaceutical, biotechnology, and medical device companies to bring new treatments to market. Company services span the entire lifecycle of product development and can be adapted to suit small local trials or large global programs. Training will take place at three California locations in San Diego, San Francisco, and El Segundo. ICON has recently acquired a business unit which provides new and complementary services to the biopharmaceutical and medical device companies. Training will facilitate the integration of new business units into the ICON organization. ETP Single (08/16/12) 2 of 4

3 ICON Clinical Research, Inc. September 20, 2013 ET ICON is also implementing a new software system - Electronic Trial Master File system (ICOMaster). This is an electronic document filing system to support filing, archiving and retention of clinical trial documentation and will drastically reduce paper files. The new system allows for documents to be filed and accessed electronically from anywhere by ICON staff and clients, reduces courier shipping of paper documents, and reduces fire protected filing rooms within company offices. Employees company-wide need to be trained in the new ERP system. PROJECT DETAILS Training Plan Training is scheduled to start in October and will be provided by in-house staff and outside vendors. Vendors have yet to be identified. Training will be provided as class/lab and Computer-Based Training (CBT), with CBT being approximately 5% of the total training per trainee. Training will be in the following: Business Skills (16%) - Training will be offered to all occupations and includes coaching, effective presentations, and managing projects within trainee work areas. Training will provide staff with tools to support company goals and to better communicate with customers and peers. Commercial Skills (45%) - Training will be offered to Managers, Research, IT, and Operations Staff, and will provide trainees with skills to respond quickly to customer requests and changing standards. Computer Skills (25%) - Training will be offered to all occupations. Trainees will learn how to use various software programs including electronics data capture system, trail master file system, e-learning systems, Project Planning & Resourcing systems and Trackwise software systems. In addition, all occupations will be trained on the new ERP system ICOMaster. Continuous Improvement (5%) - Training will be offered to all occupations and will provide trainees skills to make significant improvements in standard operations and ICON business procedures. Trainees will also have the tools to implement process improvements and streamline projects. Management Skills (9%) - Training will be offered to Managers to improve supervisory and employee management skills and improve working relations within the organization. Commitment to Training ICON reports an annual budget of $103,000 and currently provides regulatory and professional development training as well as on-the-job training for specific occupations. The Company also provides training to meet the particular needs of the employees or units. Safety training is, and will continue to be, provided in accordance with all pertinent requirements under state and federal law. RECOMMENDATION Staff recommends approval of this proposal. DEVELOPMENT SERVICES The IM Group in Fairfield, Connecticut assisted with development of this proposal for a flat fee of $7,000. ETP Single (08/16/12) 3 of 4

4 ICON Clinical Research, Inc. September 20, 2013 ET ADMINISTRATIVE SERVICES The IM Group in West Hollywood will perform administrative services for a fee not to exceed 10% of payment earned. TRAINING VENDORS To Be Determined ETP Single (08/16/12) 4 of 4

5 ICON Clinical Research, Inc. ET Exhibit B: Menu Curriculum Class/Lab Hours Trainees may receive any of the following: BUSINESS SKILLS Client Interaction Clinical Project Manager Contract Management Data Integration & Standardization Training Effective Communication Employee Essentials (Employee Effectiveness Training) Facilities Management Financial Acumen for Non-Finance Managers Investigator Payments and Grants System Training Issue Escalation Negotiation Skills Operational and Business Process Training Performing Under Pressure Presentation Skills Project Management Methodology Project Management/Clinical Trial Management Service Department Training Time Management How to Train-the-Trainer Working with a Global Team COMMERCIAL SKILLS Analysis Data Model Implementation After Hours SAE Reporting US Altiris Support Services Training Accelerated Payments Entitlement Calculation System Training for Clinical Audit Review Bid Defense Presentation Skills for Clinical Operations US Case Reporting Client Specific Training Clinical Research Assistant Training Program Clinical Research Associate Foundation Program Clinical Research Associate Technical Training Clinical Research Associate In-Field Visit Training Conducting In-Field Training Visits Consulting Fundamentals Clinical Research Associate Manager Training Data Management Audits Data Management Interactions & Information Drug Development Overview ETP 100 Exhibit B Menu Curriculum (02/13/12) 1 of 4

6 ICON Clinical Research, Inc. ET Estimating Investigator Fees and Grant Plan Clinical Trial Field Visit Procedures Good Documentation Practice ICOMaster Electronic Trial Master File System ICOTrial (Clinical Trial Management System) Process & Procedures Interdepartmental Reporting Investigator Budget Development and Negotiations Investigator Meetings Investigator Meetings - Audits Medical Coding Medical Terminology & Definitions Medical Terminology & Definitions Monitor Assessment Visit Train-the-Trainer Preparation for Audits Regulatory Training including Good Clinical Practices Serious Adverse Event Reporting in Clinical Trials Site Discussions Therapeutic Area/Medical Training Training Record Audits and Preparing for Internal/External Audits Vendor Selection and Management COMPUTER SKILLS Case Report Tabulation Data Set Specification Creation and Validation Clinical Trial Management System Training Dynamic Trip Report Focus Session Dynamic Trip Report System Electronic Data Capture System and Business Process Training Electronic Trial Master File System and Business Process Training ICONImmediate Knowledge System and Process Training idoc Software InForm Software Information Technology - Active Directory Groups and Permissions Information Technology - Netapp Storage System iq for Quality Assurance irecruit Oracle Clinical Remote Data Capture Train-the-Trainer OC RDC Software Operational Metrics Repository Reporting (Systems Training) Online Learning Content Development Process for Trainers OptICON (Optical Scanning) System Training Oracle Clinical Planview Software Project Planning and Resourcing System Training RAVE Electronic Data Capture System Training Statistical Analysis System Enterprise Software Study Recruitment System Trackwise System and Process Training ETP 100 Exhibit B Menu Curriculum (02/13/12) 2 of 4

7 ICON Clinical Research, Inc. ET CONTINUOUS IMPROVEMENT Business Process ICON Clinical Process Improvement Standard Operating Procedures MANAGEMENT SKILLS (Managers Only) Building & Leading Teams Coaching Conflict Management Effective Meetings Leadership Management Essentials (People Management Training) CBT Hours 0 20 BUSINESS SKILLS Employee Essentials (Employee Effectiveness Training) (0.5 hr) Feedback Fundamentals (0.5 hr) Financial Acumen for Non-Finance Managers (0.5 hr) Investigator Payments and Grants System Training (0.5 hr) Project Management Methodology (0.5 hr) Time Management (0.5 hr) COMMERCIAL SKILLS Accelerated Payments Entitlement Calculation System Training for Clinical (0.5 hr) Client Specific Training (0.5 hr) Fundamentals of Patient Enrolment and Retention (0.5 hr) Good Documentation Practice (0.5 hr) Medical Terminology & Definitions (0.5 hr) Regulatory Training including Good Clinical Practices (0.5 hr) Serious Adverse Event Reporting in Clinical Trials (0.5 hr) Therapeutic Area/Medical Training (0.5hr) Data Management Introduction (0.5 hr) ICOTrial Clinical Trial Management System (0.5 hr) COMPUTER SKILLS Computer System Validation Overview (0.5 hr) Electronic Data Capture System and Business Process Training (0.5 hr) Electronic Document Management System Training (0.5 hr) Electronic Trial Master File System and Business Process Training (0.5 hr) Trackwise iassess Module for Monitoring Assessment Visits (0.5 hr) ICONIK Software (0.5 hr) idoc Software (0.5 hr) ilearn End User Training (0.5 hr) ilearn(learning Management System) Manager Training (0.5 hr) ETP 100 Exhibit B Menu Curriculum (02/13/12) 3 of 4

8 ICON Clinical Research, Inc. ET InForm Electronic Data Capture System (0.5 hr) Introduction to Electronic Data Capture for Clinical Operations (0.5 hr) Trackwise iq Module for the Non-QA User (0.5 hr) Learning Management System Training (0.5 hr) Oracle Clinical Remote Data Capture Software (0.5 hr) Planview Software (0.5 hr) Project Planning and Resourcing System Training (0.5 hr) RAVE Training (0.5 hr) Trackwise System and Process Training (0.5 hr) CONTINUOUS IMPROVEMENT Client Specific Training (0.5 hr) ICONImmediate Knowledge System and Process Training (0.5 hr) Standard Operating Procedures (0.5 hr) MANAGEMENT SKILLS (Managers/Supervisors Only) Management Essentials (People Management Training) (0.5 hr) Note: Reimbursement for retraining is capped at 200 total training hours per trainee, regardless of the method of delivery. CBT is capped at 50% of total training hours, per trainee. ETP 100 Exhibit B Menu Curriculum (02/13/12) 4 of 4