Clinical Quick Reference Guide 3 Welcome to the ELVIS Quick Reference Guide. When you are completing your CV, you will be guided through the tabs at the top to complete. There will be four different types of fields: Field Type Description Mandatory Free Form Fields mandatory fields will be indicated by an (*). These fields you are required to enter information for, but the information that you enter will be typed into the open field. Mandatory Drop Down Lists, mandatory fields will be indicated by an (*). These fields are also required, but you will make your selection from a drop down menu. Optional Free Form Fields These fields are not required, and the information that you enter will be typed into the open field. Optional Drop Down Lists These fields are not required, and the information that you enter will be typed into the open field. The remainder of this document will walk you through the process tab by tab.
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Clinical Quick Reference Guide 3
Welcome to the ELVIS Quick Reference Guide. When you are completing your CV, you will be guided through the tabs at the top to complete. There will be four different types of fields:
Field Type DescriptionMandatory Free Form Fields mandatory fields will be indicated by an (*).
These fields you are required to enter information for, but the information that you enter will be typed into the open field.
Mandatory Drop Down Lists, mandatory fields will be indicated by an (*).
These fields are also required, but you will make your selection from a drop down menu.
Optional Free Form Fields These fields are not required, and the information that you enter will be typed into the open field.
Optional Drop Down Lists These fields are not required, and the information that you enter will be typed into the open field.
The remainder of this document will walk you through the process tab by tab.
Clinical Quick Reference Guide 3
Employee
Mandatory Free Form FieldsField Business Unit Requirement
Summary
Overall summary of clinical trial experience to date. See sample text below. Example: CTL
Since (enter year) in Clinical Research. Strong background in clinical monitoring experienced in all aspects of project phases from site selection to close-out in X, Y, Z therapeutic areas. Experience in Clinical Project Management since (enter year) of international teams of monitors (across different geographic regions - enter applicable regions?) to ensure timely delivery of clinical part of trial to expected quality, using agreed systems and tools.
Optional Free Form Field Field Business Unit Requirement
Certification Suffix
Enter when applicable (Msci/MSci, PhD, MD, BS/BSc, MPH, PMP, CCRA, CCRC, RN etc). If you have multiple degrees, i.e. Msci and PhD enter ONLY the highest certification.
Clinical Quick Reference Guide 3
Formal Education History
Mandatory Free Form FieldsField Business Unit Requirement
Institution Name Enter name of academic institution
Education Level/Degree Enter applicable (MSci, PhD, BA etc), Nurse (type A, B, C), Physiotherapist OR any professional degree (non-academic)'.
Area of Study Pharmacy, Medicine, Chemistry, Biology, Nursing, Business Administration, etc
Mandatory Drop Down ListField Business Unit Requirement
Country Select from drop down
Completion Status
Click on Value cell and choose from drop down list. "Attended- not Completed" means you interrupted your courses at certain point. "In progress" means that you are actively following your courses with intention to complete.
Optional Free Form Field Field Business Unit Requirement
Last Date AttendedComplete only when completion status has a "Completed" or "Attended -not completed" value. Enter your education information from most to least recent
Clinical Quick Reference Guide 3
Quintiles Employment History
Mandatory Free Form FieldsField Business Unit Requirement
Job Title The job title you enter in this field should be your job role. Please don’t use abbreviated titles. Example: Clinical Research Assoc rather than CRA/CRA 1.The title is written in the drop down as Clinical Research Assoc.
Key Responsibilities Please complete this field by using the text from the Responsibilities section of your job description which is posted on QZONE. Note there is a 2,000 character limit per entry. You can copy and paste directly from the job description into the CV template. Change to past tense for all roles except current position.
http://hrcareer.quintiles.com/CareerManagement/JobDescriptions/Pages/Default.aspx. Do not create original text.
Cooperate closely with Project Manager and other project leads.
Mandatory Drop Down ListField Business Unit Requirement
Start DateSelect from calendar. Current job title should be first entry. If multiple roles within Quintiles, last entry will more than likely be the date of employment at Quintiles.
Optional Free Form FieldField Business Unit Requirement
Business Title Complete only if you have another formal title apart from your Job title. If unsure please check with HR to confirm.
Clinical Quick Reference Guide 3
Mandatory Drop Down ListField Business Unit Requirement
End DateSelect from calendar. Current job title (s) will not have an end date (s). All previous entries will have an end date.
Clinical Quick Reference Guide 3
Non Quintiles Employment History
Mandatory Free Form FieldsField Business Unit Requirement
Name of Employer Full company name - do not use abbreviations
Job Title As used by former employer, full name, do not use abbreviations
Key Responsibilities
Should be the same convention for description - CRA, CTL, SSU, LM, etc. as for Quintiles employment, use past tense, as these responsibilities pertain to employment preceding Quintiles. Limit responsibilities to key/major responsibilities of previous role. Enter most to least recent for previous employment. Enter as past tense.
Mandatory Drop Down ListField Business Unit Requirement
Start Date Select from calendar
Optional Drop Down List Field Business Unit Requirement
End Date Select from calendar
Clinical Quick Reference Guide 3
Quintiles Clinical Trial Experience
Mandatory Free Form FieldsField Business Unit Requirement
Key Responsibilities
Please complete this field by using the text from the Responsibilities section of your job description which is posted on QZONE. Note there is a 2,000 character limit per entry. You can copy and paste directly from the job description into the CV template.http://hrcareer.quintiles.com/CareerManagement/JobDescriptions/Pages/Default.aspx
Example: if a Sr. CRA is acting as a support of the CTL on a study, the key responsibilities are needed to be detailed. Other example: if a CTL is acting as a Report Reviewer, the key responsibilities are to be detailed. If a CTL is acting as a CTL, only the coverage should be detailed, for example: Regional CTL; LatAm CTL for Brazil, Chile and Peru; Global CTL.
Mandatory Drop Down ListField Business Unit Requirement
Customer
Select from drop down. This should be completed as this field is for internal
purposes only and will not appear on the external CV document. For Customers that don’t match any of the drop down choices, please use the option of OTHER. The list is currently being finalized and will have updated options in the future.
Study Phase Select from drop down
Indication
Select from drop down. For indications that don’t match any of the drop down choices, please use the option of OTHER. The list is currently being finalized and will have updated options in the future.
Role Enter your job role. This should match what you have entered for your job
Clinical Quick Reference Guide 3
title on the previous Employment tabs. Example: NOT CRA or CRA 1, but Clinical Research Assoc.
Optional Free Form Field Field Business Unit Requirement
# of Countries Not required
# of Sites Not required
# of Patients Not required
Optional Drop Down List Field Business Unit Requirement
Special Population Select from drop down (Not required for North America)
Drug Class Select from drop down
Start Date Enter date you started on trial
End Date Enter date you completed the trial/transferred responsibility
Clinical Quick Reference Guide 3
Non Quintiles Clinical Trial Experience
Mandatory Free Form FieldsField Business Unit Requirement
Key Responsibilities
It should not be redundant in cases when the role in the study is different than the job title. Example: if a Sr. CRA is acting as a support of the CTL on a study, the key responsibilities are needed to be detailed. Other example: if a CTL is acting as a Report Reviewer, the key responsibilities are to be detailed. If a CTL is acting as a CTL, only the coverage should be detailed, for example: Regional CTL; LatAm CTL for Brazil, Chile and Peru; Global CTL.
Mandatory Drop Down ListField Business Unit Requirement
Study Phase Select from drop down
Indication
Select from drop down. For indications that don’t match any of the drop down choices, please use the option of OTHER. The list is currently being finalized and will have updated options in the future.
Role
Enter your job role. This should match what you have entered for your job title on the previous Employment tabs. Example: NOT CRA or CRA 1, but Clinical Research Assoc.
Optional Drop Down List Field Business Unit Requirement
Industry TypeComplete if you can chose one of these: CRO, pharmaceutical, bio-technology, academic, site
Special Population Select from drop down
Drug Class Select from drop down
Geographic Region Select from drop down
Clinical Quick Reference Guide 3
# of Sites Select from drop down
# of Patients Select from drop down
Start Date Date you started in the role
End Date Date you completed or transferred responsibilities
Clinical Quick Reference Guide 3
Therapeutic Area Experience
Mandatory Free Form FieldsField Business Unit Requirement
Describe Experience Skip this page
Clinical Quick Reference Guide 3
Department Specific Experience Biostatistics
Optional Drop Down List Field Business Unit Requirement
AllClick to access the drop down to pick the appropriate department and complete the appropriate experience.
Clinical Quick Reference Guide 3
Department Specific Experience – Clinical
Optional CheckboxField Business Unit Requirement
Audits and/or Regulatory Inspection
Select if applicable
Closure Visits Select if applicable
Collection and review of regulatory packages
Select if applicable
Conducting CRA Training
Select if applicable
Conducting GCP Training
Select if applicable
Drug Accountability Select if applicable
eDC Monitoring Select if applicable
Feasibilities Select if applicable
ICF/Study document development
Select if applicable
Initiation Visits Select if applicable
International Project Experience
Select if applicable
Clinical Quick Reference Guide 3
Investigator Meeting Attendance
Select if applicable
Liaising with Customer and/or External Vendors
Select if applicable
Line Management of Clinical Staff
Select if applicable
Management of International Clinical Team
Select if applicable
Management of SAE’s Select if applicable
Monitoring Visits and Source Data Verification
Select if applicable
Query Resolution Select if applicable
Re-Labelling and/or IP Recall process
Select if applicable
Remote Monitoring Select if applicable
Site Contracting Select if applicable
Site Selection Visits Select if applicable
Study Files Maintenance
Select if applicable
Submissions to Regulatory Bodies and/or to Ethic Committees
Select if applicable
Clinical Quick Reference Guide 3
Department Specific Experience Project Management
# of YearsField Business Unit Requirement
All Skip this page
Clinical Quick Reference Guide 3
Languages
Mandatory Drop Down ListField Business Unit Requirement
Languages Click on "value" and choose applicable
Speaking Select from drop down
Reading Select from drop down
Writing Select from drop down
Clinical Quick Reference Guide 3
Current Memberships in Professional Organizations
Mandatory Free Form FieldsField Business Unit Requirement
Name of Organization Use full name and do not abbreviate
Clinical Quick Reference Guide 3
Publications, Doctoral Thesis
Mandatory Free Form FieldsField Business Unit Requirement
PublicationsMost current on the top. Journal publications and congress/meetings presentations published in abstracts (100 lines max)
Clinical Quick Reference Guide 3
Licenses and Certifications
Mandatory Free Form FieldsField Business Unit Requirement
Licenses, Certifications Enter those that are currently valid. 50 lines max
Mandatory Drop Down ListField Business Unit Requirement
YearSelect from drop down. For certifications that are renewed (ie. annually, etc). Select the year the initial license/certification was obtained.
Clinical Quick Reference Guide 3
Award and Honors
Mandatory Free Form FieldsField Business Unit Requirement
Awards and HonorsEnter all received - academia, international awards, business awards. Do NOT enter the Work Worth Doing and other Quintiles internal awards
Mandatory Drop Down ListField Business Unit Requirement
Year Select from drop down
Clinical Quick Reference Guide 3
Other
Optional Free Form Field Field Business Unit Requirement
Relevant Non-Clinical Training
Enter external business courses i.e. negotiations, assertivness, people management, project management, regulatory, QA/QM, and language courses.
OtherPlease enter any additional relevant experience not captured in other CV pages.
Additional guidance
TroubleshootingIf you are experiencing issues with the functionality of the ELVIS CV document, please log a GETIT ticket so we can track and log all queries. This will allow us to catalogue and resolve in a timely manner for you.
ModificationsAny questions you have on the completion of the CV or any suggested changes /requirements you have to the CV Form, User guide or Drop downs should also be submitted via a GETIT ticket and will be managed by the ELVIS CV Governance process.
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