Genesis Thomas Email and Phone Number

 Provide (cross functional) clerical and administrative support to project team(s) Maintain study-specific tracking reports (e.g. patient enrollment, regulatory documents, site visits) Prepare and compile study related materials including investigator meeting binders, training manuals, and Study File Notebooks Obtain, review, and process regulatory and administrative documents from investigator sites When allocated by study management, collection and preparation of essential/ required documents for submission to a central Institutional Review Board (IRB) or a country's central Ethics Committee, and if necessary based on local requirements the Competent Authority Set up, maintain and review regulatory and administrative documents for the Trial Master File (TMF) Assist in the identification and recruiting activities for clinical trial investigators Assist CRA (for e.g. training purposes) to ensure compliance with inVentiv Health Clinical and project SOPs  Resolve issues, questions, and requests for additional study supplies Review investigator files to ensure all documentation is complete and up-to-date Negotiate study budgets with investigators Review Case Report Forms (CRFs) and other clinical data for completeness and accuracy Resolve queries of CRF data with study site personnel Review Tables and Listings generated from study data Assist project team(s) in updating project reports and plans, and meeting minutes

 Assisted in the implementation in the Pediatric Critical Care Unit (PICU)  Data Monitoring and Management Maintained communication with outside facilities and Principal Investigators Maintained study records Develop SOPs OnCore Training Implemented and provided training to staff members IRB submission/amendments and Renewals for clinical trials and non-clinical trials Assisted with composition and preparation of regulatory/IRB documents for new study submissions, amendments, continuing reviews and close-out Consented subjects following ICH-GCP guidelines Overseen the proper handling of laboratory specimens including processes, shipping, storage, and documentation Assisted in assignment of drug and/or device supplies to research subjects Order and received drug/device supplies for studies and maintain appropriate inventory Served as advocate for the subjects and their family Initiated Research meetings for department Laboratory training Schedule and/or coordinated study-related meetings Recruited subjects according to IRB-approved protocols Scheduled study visits, completed all necessary pre-visit task and executed study procedures according to protocols and clinical needs

• Follow IRB protocol for each study/ HIPPA regulations.• Approach patients in a clinic setting and/or over the phone.• Administer studies based on IRB and Study protocol.• Develop SOP’s for Database and Research studies for future Research Assistants (RA).• Develop summaries from meetings to be transcribed.• Prepare rooms for monthly/bi-weekly board meetings. • Develop relationship with clinic/Research Study staff.• Document study/patient information using G3, Careweb, and REDCap database• Look up Patient Information using Wishard and IUH system(s): Careweb, McKesson , RCIS and/or Cerner for Inclusion/Exclusion criteria(s).• Provide training for new hire Research Assistants. • Interview future Research Assistants. • Assist in Chart Audits• Run Reports from database• Develop Electronic Newsletter

• Facilitate Position within support groups.• Display excellent networking skills to generate services for families. • Home visit with Prenatal/Postnatal Mothers.• Displays strong computers skills.• Displays strong knowledge of child development to assist mothers/families. • Discuss and adjust treatment plans from supervisory meetings. • Generate reports and input in computer using company software. • E-Parenting Training. • Numerous training in Child development and Child Abuse Prevention.• Assess Family-child interaction. • Assess Family need based on individual/family interaction.

• Assist low-income individuals to reach self-sufficiency. • Prepare individualize goal plans for clients. • Home visit/ office visits with each individuals based on CSS report and/or client.• Conduct Workshops for employment training for adults and youth.• Facilitate Youth Summer Program teaching career goals, life skills and nutrition• Discuss and adjust treatment plans from staff team meetings. • Generate Monthly Reports for each client encounter.• Display networking skills to organizations to assist families in need.

• Assist clients with developmental /mental disabilities daily living skills. • Prepare individualize treatment plans. • Administer medication to clients.• Assist clients with supportive employment duties.• Chart progress of each client.• Discuss and adjust treatment plans from staff team meetings.• Medication Reminders• Transport to Doctor Appointments, Workshops, Job Placements and etc. • Supervise in-house CLS staff• Oversee/Manage clients financial and banking needs.

• Prepare student packages for future applicants.• Computer work with Microsoft Office. • Compose marketing brochures.• Knowledge of programs available for IU students in different countries and reservations.• Organize reports.

• Assist nurses with patient hygiene duties. • Take patients vital signs (B/P, temp., weight, height, pulse, O2 stats, etc).• Chart patient’s activities and daily living progress.• Assist patients with ADL’S (Activities of Daily Living)• Transport patients to activities.• Develop activities at patient level.