Mini Rounds Wednesday, May 21, 2014

Transcription

1 Mini Rounds Wednesday, May 21, Updates New Staff and Current Vacancies Standing Meetings Reminder All Staff Announcements CRCO Inbox Central Office Central Office move Roles and Responsibilities Updates New Employee Information SOP Task Force Townhall Impression Suggestions for future Mini Rounds

2 New Staff and Current Vacancies

3 New Staff and Current Vacancies

4 Standing Meetings Reminder Current List of standing meetings available on the UWCCC Intranet site under SOPS/Forms/Documents: General If you d like to attend or have questions regarding any meetings please contact the facilitator listed below

5 2014 All Staff Announcements CRCO Inbox What is the CRCO Inbox? Inbox shared by the Clinical Research Central Office Utilized by the CRCO to send out pertinent updates to all research staff Monitored on a daily basis Why is this important? Partly as a friendly reminder to please review any s received from the CRCO inbox. Many messages contain important information regarding updates to processes, staff changes, and training and certification requirements for all employees. You can the inbox anytime with questions for the central office team

6 2014 All Staff Announcements CRCO Inbox Examples of regular updates that are sent out: UWCCC Clinical Research Contact List Sent out monthly eprms Radiology Collaborator Sign-off Updates Alerts when Katie Kovacich will be out of office to make alternative plans for sign-off Health Link PRN Newsletters for Health Link Users providing helpful updates Billing Slip issues sent 2/17/2014 referencing blank billing slips and how to handle Meeting announcements Mini Rounds, Research Staff Forum, Town Hall Tissue Request Guidance Tissue Request Guidance Document sent 4/9/2014 NCI-CIRB Updates NCI CIRB SOP and checklist sent 4/21/2014 PRMC Updates DOWG PRMC Submission SOP and 2014 PRMC Meeting and Deadline Schedule sent 4/21/2014 Guidance Documents and SOP Updates Study Activation Guidance sent 4/29/2014 Updated SOP Template sent 5/8/2014

7 Central Office Move The Compliance portion of the Central Office has moved to: K4/659 Who does this consist of? Belinda Buehl-Soppe Vara Parameswaran Shari Zeldin Emily Jenner Courtney Thom Keayra Morris (student) What about the PRMC Coordinator? Claire has joined the Services office and is located in K4/661. Her phone number and address are the same. What does this mean? Outside Safety Report (OSR) and Archiving Label Order drop offs are now located in K4/659 please give all paperwork to Bel. As a recap the location for Monitors has now changed. The following slide outlines the instructions for reserving space. None of the phone numbers or addresses have changed for Compliance Staff, please feel free to continue to call or us if you have questions.

8 Monitoring Room Changes The new monitoring rooms are as follows: Room #1: J4/603, (the old GynOnc DOWG office) will be able to accommodate up to 3 monitors. Room #2: K3/601A will be able to accommodate 2 monitors. Room #3: K3/601B will only accommodate 1 monitor, and will be considered last and only assigned if the number of monitors for any given day exceeds 5 monitors. To reserve a monitoring room, you must uwcccfrontdesk@uwcarbone.wisc.edu and list out: - Your name and phone number - Company name/monitor name or study number - Indicate if there will be more than one monitor coming A Reservation confirmation will be sent back to you and will include the room number your monitor(s) has been assigned to. Important: If a monitor cancels, please send that information to the Front Desk as it could potentially free up a space for another group's monitor. Please let the front desk know if you have not received confirmation for any monitors who may have needed to be relocated due to the move. Thank you for your patience during this process!

9 Central Office Roles and Responsibilities The Clinical Research Central Office is available to provide assistance for the groups in a wide variety of areas. Highlighted below are the official roles and main duties of the Central Office staff: Katie Wulff Associate Director of Clinical Research Served the Cancer Center for over 1 year Main duties: Oversight of the entire Clinical Research Program Serve as a liaison for UWCCC and UWHC, External Sponsors, NCI, the University Supervises Central Office Managers and select staff & Chemoprevention DOWG Compliance Office Shari Zeldin Compliance Office Manager Served the CRCO for over 8 years Main duties: Compliance Office Oversight Training and Education DSMC Member

10 Central Office Roles and Responsibilities Emily Jenner Compliance and Monitoring Specialist/Data and Safety Monitoring Coordinator (DSMC) Served the CRCO for 3 years Main Duties: Co-coordinate Data and Safety Monitoring Committee Lead External Auditor/participates in Internal Audits Point of Contact for the affiliate network for ECOG/NCTN trials Belinda Buehl-Soppe Clinical Trials Reporting Program (CTRP)/Education and Training Coordinator Served the CRCO for over 3 years Main duties: CTRP and ClinicalTrials.gov (CT.gov) Coordination Education and Training Assistance Auditing Assistance Vara Parameswaran Compliance and Monitoring Specialist/Data and Safety Monitoring Coordinator (DSMC) Served the CRCO for 10 months Main Duties: Co-coordinate Data and Safety Monitoring Committee Lead Internal Auditor/participate in External Audits and conduct all QARs at UWCCC SAE/SOP Task Force Coordinator

11 Central Office Roles and Responsibilities Courtney Thom Affiliate Coordinator Served the CRCO for 10 months Main Duties: Point of Contact for the Wisconsin Oncology Network (WON) for UWCCC Facilitates clinical trial administration, including budgets and subaward agreements Assists in study initiation training and leads monthly WON Teleconferences with sites Services Office Janna Bergum Budgetary Compliance Specialist Served CRCO for 8 months and UWCCC over 7 years Main Duties: Compliance Review of OnCore protocol calendar builds Medicare coverage analysis of studies Calendar builds training for new staff Claire Kostechka Protocol Review and Monitoring Coordinator (PRMC) Served CRCO for over 1 year Main Duties: QA, protocol assignment, and Administrative support for the PRMC Performs OnCore QA s for new protocol number requests and status changes Completion of UW Compliance Checks for CIRB

12 Central Office Roles and Responsibilities Vielska Brautigam Budgetary Compliance Specialist Served the CRCO for over 3 years Main Duties: Develop industry budgets Negotiate wit Sponsors Update and further develop UWCCC s Standard Budget Guidelines Shared Regulatory Specialist Currently Vacant Manage Center-wide Grants (NCTN, Umbrella Grants) to include: IRB submissions, money allocation, progress reports Lead Regulatory Forum, act as a Mentor to new Regulatory Staff Function as needed as DOWG Regulatory Specialist when coverage is needed Operations Manager NEW POSITION, PVL to be online soon Lead clinical trial business initiatives to continuously improve processes and communications to build operationally efficient systems Work directly with DOWG PMs to establish SOPs and workflows Train/mentor new PMs and help with PM coverage when needed This is just a brief overview of the roles within the Central Office.

13 CRCO Update - New Employees We provide assistance for hiring new employees. There are 2 checklists that can provide guidance for training new staff: Checklist for New UWCCC Employees Found online at - Administration This checklist outlines the training requirements for all UWCCC New Employees, how to take the training, and where to submit the information It will be getting updated within the next few months to transfer it to the new SOP template as well as clarifying information and links for the training New Student Employee Checklist This is a newly created document to meet the needs of groups for training new students It is currently under review by HR staff for additions or clarifications but will be made available once completed

14 CRCO Update SOP Task Force SOP Task Force Reinstated as of Coordinator: Vara Parameswaran. Members meet monthly to update existing SOPs and create new SOPs. SOPs that have been reviewed and updated nearing completion: Record Storage SOP SOP on Preparation and Maintenance SOPs in progress Processing Outside Safety Reports Completion of Form FDA 1572 SOPs to be created Clinical Trial Budget Preparation: Industry and IIT SOP Protocol Activation SOP

15 CRCO Update SOP Task Force New Website Model Health Sciences IRB Website Suggestions for Quick Links ~ Fall 2014

16 Townhall Impression The Townhall meeting was recently held on April 10, It provided a brief overview of the state of affairs regarding the UWCCC and future plans. If anyone has any thoughts or questions regarding the Townhall feel free to ask!

17 Suggestions for Future Mini-Rounds Mini Rounds is meant to be a set time each month to provide timely information to the groups The format is being updated in order to come up with a more set schedule of meetings and to continue to provide guidance and training The focus this month spotlights the CRCO since there have been staff organizational changes and office location changes What about continuing this format each month and perhaps featuring one DOWG per month? Each group could prep an overview slide or two to give a highlevel overview of their team, types of trials, etc. What other suggestions are there for topics?

18 Questions?