Preparing the Next Workforce Apprenticeships in Quality

Transcription

1 Preparing the Next Workforce Apprenticeships in Quality Rosemarie Christopher Thursday: 3:45p-4:30p 12 October 2017

2 Apprenticeships in Quality

3 Veterans Graduates Caregivers Quality Improvement Associate Certificate Clinical Research Regulatory Quality Drug Safety Biostats

4 Why Auditors Need Apprentices Perfect documentation is required for Regulatory approvals. Certifications insure industry best practices are followed: important to Clients (Internal & External). There are multiple career paths for Apprentices. 87% of Apprentices are offered full time positions, much higher rate than interns. Candidates with certifications and 1-6 years of experience are the most difficult to uncover & recruit.

5 Professional Growth for Senior Staff Build A Happy Team (Drive by Dan Pink) Autonomy opportunity to manage someone Delegation Contribution make a difference in someone else s career Mastery training packages available through our Foundation Mentorship Profess. Growth Training

6 Professional Growth for Senior Staff Additional benefits Mentorship learn material better by teaching Delegation unload routine tasks Retention make the job more interesting Mentorship Delegation Profess. Growth Training

7 Benefits of Delegation Give Receive False choice: I don t have time to train!

8 Video Stories Mentors and Apprentices

9 Incumbent Apprentices Company Apprentice Already at company > 6 mo In-person mentorship Text, phone and support Prepares for CQIA Implements minor process improvements Commits to additional learning Rx Foundation Provides an external mentor 2 hours onsite 2 hours offsite Provides ASQ study materials Helps identify process improvement opportunities Identifies path toward additional relevant certifications

10 Reverse Q&A 1. What could make this program better? 2. Do you have projects that require a large amount of routine work? 3. Are there projects you are behind schedule on? 4. Do you have projects that need to be checked for completeness and accuracy? 5. Who in your organization (or clients organizations) would champion an apprenticeship program? 6. Who would dissuade (or drag their feet) and why?

11 Your Questions For Me

12 More Information Presented by Rosemarie Christopher Cell

13 Appendix

14 Reporting Requirements Apprentice has bi-weekly call with logistics coordinator Apprentices submit bi-weekly timesheets and task reports Manager reviews and signs off Manager submits quarterly performance survey Mentor submits monthly progress report (checklist) Foundation ensures program compliance

15 Responsibilities Accounts payable are billed for wages, employer taxes and benefits, which account for 1.46X hourly pay according to Bureau of Labor Statistics ( Foundation covers 8 hours training/week, certification materials and exam Rx Research processes timesheets, ensuring the apprentice stays on track with trainings and experiential requirements Rx Research ensures compliance with federal, state and employment laws and program requirements

16 Responsibilities Other W2 requirements Base Pay Supplemental pay Retirement Paid leave Legally required benefits Insurance Base pay

17 Example 1 year Base Pay $15.00 $31,200 Employer Taxes and W2 Benefits* $7.25 $15,070 Contribution** $1.00 $2,080 Total Employment Cost (before Foundation support) $48,270 8 hours /week training -($4,555) Certification materials and exam $644 Mentorship stipends $3,000 Paid by Foundation Paid by Foundation Total Foundation Contribution $7,799 Host Company Costs $40,471 *6.2% Social Security + 6% Federal Unemployment + 6.2% State unemployment % Medicaid + $1.18/hour Worker s Compensation + $2.85/hour contribution to health insurance **Search, drug testing, background checks, general liability insurance, errors and omissions insurance, payroll processing

18 Microbiology Quality Control Technician Chemistry Quality Control Technician Clinical Data Coordinator Clinical Research Coordinator Clinical Trial Associate Drug Safety Associate Quality Assurance Associate GXP Auditor Regulatory Affairs Specialist Regulatory Compliance Associate Training topics/outcomes Microbiological testing finished products Analyze microbiological test data Calibrate/maintain testing equipment Aseptic techniques Inventory control Quality assurance concepts/techniques Laboratory test methods Quality improvement tools Apply good documentation practices Industry regulatory guidances Product testing & inspection Environmental monitoring Validate data with written reports Apply good manufacturing practices Continuous improvement techniques Clinical trial team support Collect essential clinical trial data Data entry, queries/resolutions, verification Data maintenance Clinical trial operational/logistical assistance Apply good clinical practices Electronic data capture Clinical trial data oversight & support Laboratory & medical terminology Collect, maintain, & file clinical trial documentation iclinical trial oversight & support Trial master file oversight & support Drug safety management support Medical monitoring support SOP & regulatory compliance Triage incoming reports (complete, legible, valid) Safety & adverse event reporting Investigator, sponsor, monitor roles/responsibilities Inspect vendor products (stds/specs compliance) Inspect vendor facilities (stds/specs compliance) Submit audit reports (compliance, correctives) Coordinate & document internal regulatory processes Assist in compile/prepare submission docs Regulatory pathways/operations Regulatory submissions/review process Manage/integrate quality management program Manage/integrate quality improvement program Guidance/tech support for quality programs Strategic planning for recalls Industry-recognized 3rd party certification* CQIA RAC GLP OSHA 30 OSHA HAZW OPER CRCC GCP SCDM *Depending on the apprenticeship, 2 or more of the 3rd party Certifications will be obtained

19 Apprenticeships in Quality