Focus NJ's Workforce Development Initiatives & Opportunities
- Essex County
Clinical Research
American Institute of Professional Studies- Workforce Training - Healthcare
Describe the medical product path starting with discovery and ending with marketing approval. Identify the GCP obligations in protecting the rights of study subjects. Distinguish the different roles and GCP obligations between the Investigator, Sponsor, and IRB. Explain the ‘ideal’ elements used in coordinating a clinical trial. Demonstrate the ability to perform monitoring and coordinating activities and detect GCP deficiencies. Choose the different problem-solving techniques in resolving GCP deficiencies
Full Program Details Suggest an edit to this program- Somerset County
Drug Safety Medical Narrative Writing
Sollers College- Workforce Training - Healthcare
Learn about the process of coding with MedDRA and medical narrative writing in general and the ADR of various systems, and recent advances in the area of adverse drug reactions in different systems.
Full Program Details- Somerset County
Aggregate Reporting
Sollers College- Workforce Training - Healthcare
Learn how to create Periodic Safety Update Reports - now known as the Periodic-Benefit-Risk Evaluation Report, Preapproval Reports including IND Annual Reports and Annual Safety Reports, and Post-approval Periodic Adverse Experience Reports.
Full Program Details- Somerset County
Signal Detection
Sollers College- Workforce Training - Healthcare
Get comprehensive knowledge about signal detection including Empirica signal introduction, creating data mining runs and creating statistical reports generation. The course trains to use Empirica and its workflow configuration, setting preferences, navigating through tabs, and end user training.
Full Program Details- Somerset County
Advanced Clinical Research
Sollers College- Workforce Training - Healthcare
Study Startup: Understand the phases of the clinical trial, ICH-GCP guidelines, study feasibility, and site selction. Study Conduct: Learn about site monitoring visits, which include remote and central risk-based monitoring. Study Closeout: Learn about site close-out visit including both on-site and remote activites.
Full Program Details- Somerset County
Clinical Trials Management
Sollers College- Workforce Training - Healthcare
Students will have 20+ weeks of hands-on training with Clinical Trial Management System and electronic Trial Master File (eTMF) Management System from site intiation, site monitoring, and closeout. This will do through real time case scenarios, clinical tasks, and other site management activities taught by industry experts.
Full Program Details- Somerset County
Drug Safety and Pharmacovigilance
Sollers College- Workforce Training - Healthcare
This program provides a thorough understanding of the drug development process and its life cycle, regulatory issues across global governmental agencies like the FDA, EMA, ICH and others. Students gain thorough understanding of the adverse events and adverse drug reaction (ADRs), AE evaluation, dynamics of AE reporting, MedWatch forms, and ICSR processing. Students are given full fledged knowledge and access to Oracle Argus Safety database along with sample cases.
Full Program Details- Somerset County
Advanced Drug Safety and Pharmacovigilance
Sollers College- Workforce Training - Healthcare
This program provides a thorough understanding of the drug development process and its life cycle, regulatory issues across global governmental agencies like the FDA, EMA, ICH and others. This program educates students about the business dynamics of the pharmaceutical industry. Students gain thorough understanding of the adverse events and adverse drug reaction (ADRs), AE evaluation, dynamics of AE reporting, MedWatch forms, and ICSR processing. Hands-on 12 week internship training on the industry-based Oracle Argus Safety database. In the internship, students develop the ability to triage the assigned cases according to industry standards.
Full Program Details