Customer Service Quality Control

Roslyn Rogers

EDUCATION:

American Intercontinental University

BBA (Suma Cum Laude) in Health Care Management

American Intercontinental University

AABA with Honors in Health Care Administration

Licensed Life, Health, Accident, Med Supp Courses Completed

PROFESSIONAL EXPERIENCE:

PPD Inc., Morrisville, NC 3/2007-

Present

Safety Administrator IV/Manager Liaison/Lead SA 06/2012-

Present

• Manage staff of 16 Safety Administrators

• Currently on adjudication team; Electronically receiving, reviewing, processing endpoints and

related source docs

• Train new team members on endpoint processing procedures

• Electronically build dossiers with all related source docs for submission to Clinical Endpoint

Adjudication Committee for review

• Identify and send Adjudication queries to investigator sites either directly or through

CRAs.

• Using EAS for entry of documents received, query management, site follow up, and

dossier uploads

• Electronically collect and review all incoming documents for accuracy to ensure good

time management of dossier builds

• Run reports for all events using EventNet in order to maintain and uphold guidelines for

builds and site contact

• Verifying and/or confirming, and querying events in InForm

• Contacting sites electronically for documents needed to adjudicate events

• Provide administrative support to the Pharmacovigilance Department for global and

domestic clinical trials.

• Attend project team meetings, prepare and distribute meeting minutes and client

documents.

• Work in conjunction with other Safety Administrators to ensure quality of documentation

and timeliness of deliverables is achieved.

• Provide lead coordination for project support and provide the safety administrator support

staff with work direction for complex and non-complex global and domestic studies.

• Train and mentor junior Safety Administrators for the department.

• Oversight of the assigned junior support staff, problem solving, assisting with project

assignments and coverage, interviewing potential support staff, and providing input in

performance reviews.

• Responsible for resolving complex project support problems through in-depth evaluation.

• Perform data entry of site specific information from SAE report forms into safety databases as

well as Access and Excel tracking databases.

• Participate in quality control, report distribution, project file creation and maintenance for

assigned studies.

• Provide backup IIC safety support by answering the safety hotline phone, triaging incoming

investigator site documents and distributing information to the assigned project staff.

• Assist in the collation of study metrics for the team.

• Maintain project specific training records for assigned project teams.

• Assist in the audit readiness process for assigned studies and with preparation of materials for

internal and Client audits.

• Assist with SAE narrative generation.

• Responsible for supply orders by department location for all staff members. This includes

analyzing office supply needs and foreseeing future needs

• Upload project data into Livelink electronic imaging system and provide quality control of

scanned documents.

• Enhance the department’s capabilities by preparing correspondence and graphics for presentation

used at training sessions and meetings.

• Participate and assist in the interview process for new Safety Administrators

• Adhering to PPD’s corporate policies and SOPs/WPDs.

• Sending out reports, as needed to the department and generating project queries

• Set up project specific databases for protocol inquiries, physician assessment diagnostic forms

and eligibility review packets.

• Project start up and close out activities including archival of documents.

• Perform data entry of protocol inquiries, diagnostic assessments and eligibility review packets

related to Medical Monitor designated projects into project specific tracking databases.

• Responsible for distributing documents to the appropriate staff (Medical Monitor, Safety

Specialist) for review/processing.

• Track and collect required documentation for assigned projects and distribute to the staff

for review

• Perform project time management for monthly budgets.

• Assist with reconciliation of data listing reports.

• Assist with preparing proposals, contract modifications and budget maintenance.

• Utilize STS and/or ARISg for patient data management and entry

• Attend safety teleconferences with client and project teams and generate and distribute meeting

minutes.

• Assist with Safety Medical Management Plan and process flow preparations.

• Assist in the preparation of departmental WPDs and SOPs as well as preparation and

implementation of pertinent guidelines or directives.

Safety Administrator III 10/2010-

10/2012

• Serve as Safety Administrator to provide administrative support to the Medical Affairs

Pharmacovigilance Division for global and domestic clinical trials.

• Create new files and maintain the current internal project and departmental administrative filing

system so that information is readily available and accessible.

• Train new safety support staff in department administrative and project related tasks and provide

leadership and direction in department administrative and project related tasks. May provide work

direction and direct work flow processes under the supervision of applicable PVG staff.

• Assist with data entry of initial SAEs and follow-up information, quality control, and report

distribution.

• Electronically distribute safety database reports internally and externally under the direction of

the safety team

• Set-up, logging, tracking and maintaining the project SAE tracking database, tracking initials and

follow-up SAE reports and distributing documents to the designated regulatory file location

• Electronic distribution of project tracker reports to the Sponsor and project team.

• Writing narratives and assisting with narrative QC

• Electronically indexing SAE documents into LiveLink imaging system and quality control of

scanned documents.

• Compiling SAE case files and allocates to the appropriate safety team for review/processing.

• Electronically indexing documents into LiveLink imaging system and quality control of scanned

documents.

• Electronically distributing documents to the appropriate Medical Monitor for review/processing.

• Electronically distributing documents to the appropriate Safety Specialist/Medical Monitor for

review/processing

Safety Administrator II 7/2008-10/2010

• Serve as Safety Administrator II to provide administrative safety support to the staff in the

Medical Affairs Pharmacovigilance Division for global and domestic clinical trials.

• Perform data entry of site specific information from protocol inquiry forms, lab report forms and

serious adverse events into safety databases as well as Access and Excel tracking databases,

faxing, scanning documents, and report distribution internally.

• Assisted with triaging incoming investigator site documents and distributing information to the

investigator sites, project teams and Clients.

• Mentoring and training new safety support personnel and other departmental responsibilities as

delegated by the Safety Administrative Manager and/or management team.

• Utilize AERS for entry and management of patient data

• Perform general administrative support for the department including maintenance of supplies and

office machines.

• Responsible for adhering to PPD’s corporate policies and SOPs/WPDs.

• Participating in quality control, report distribution, project file creation and maintenance for

assigned studies.

Safety Administrator I 3/2007-

7/2008

• Serve as Safety Administrator I to provide administrative safety support to the staff in the Medical

Affairs Pharmacovigilance Division for global and domestic clinical trials.

• Perform data entry of site specific information from protocol inquiry forms, lab report forms and

serious adverse events into safety databases as well as Access and Excel tracking databases,

faxing, scanning documents, and report distribution internally.

• Assisted with triaging incoming investigator site documents and distributing information to the

investigator sites, project teams and Clients.

• Mentoring and training new safety support personnel and other departmental responsibilities as

delegated by the Safety Administrative Manager and/or management team.

• Perform general administrative support for the department including maintenance of supplies and

office machines.

• Responsible for adhering to PPD’s corporate policies and SOPs/WPDs.

• Participating in quality control, report distribution, project file creation and maintenance for

assigned studies.

JL Walston and Associates, Durham, NC 1/2006-

1/2007

Client Services Rep

• Answer incoming calls from debtors and clients and assist caller or transfer calls to proper party

• Complete client research i.e., verifying payments, balance inquiries, insurance holds, etc via

clients' IDX system

• Process incoming and outgoing mail and deliver to proper party

• Post and process all payments

• Tally payments from debtors before posting

• Match and merge debtors accounts to prevent duplicates

• Log on to client system to retrieve payments via secure connection

• Send budget plan information to client via spreadsheet

• Position ended due to better offer with benefits

Real Estate Consultants, Durham, NC 9/2003-

1/2006

Office Manager

• Record, manage, and reconcile budget and office expenditures; process outgoing and incoming

invoices

• Manage all existing properties

• Manage all systems and databases

• Develop and implement records management

• Organize office setup and condition; also maintain all office supplies

• Organize and chair meetings with staff; Delegating roles for meeting such as the recordings,

meeting minutes, and agenda

• Oversee recruitment of new staff, including training and induction

• Ensure adequate staff levels for coverage during absences and peaks in workload

• Carry out staff appraisals, manage performance and discipline staff

• Delegating work to staff and managing their workload and output

• Promote staff development and training

America Online Inc., Abq, NM

8/2002-9/2003

Retention Specialist/Customer Service Rep/Team Lead

• Answer incoming calls from members having problems with accounts

• Persuade members to keep accounts and make necessary offers of value

• Educate members on value of accounts and assist with any issues that may be the cause of

cancellation

• Educate members on billing and any other issues or concerns customer may have

LIP Inc., Durham, NC

10/2000-8/2002

Customer Service/Sales Rep/Receptionist

• Answer incoming calls from customers (from general inquiry to placing orders)

• Place orders and send orders to customers via Fed Ex or UPS

• Complete call tag requests placed by other employees and customers

• Complete call tag reports for budgeting purposes

IBM, RTP, NC

8/1998-9/2000

Team Lead/HR Specialist II

• To train all incoming level two employees in the duplication process in human resources

• Assist with weekly payroll completion for entire team

• Assist with interviews and provide feedback to Hiring managers

• Delegate work responsibilities to team as needed

• To oversee workflow of employees to ensure accuracy of database

• Organize all department events and projects

• Assist in the ERBP (Employee Referral Bonus Program) dept. to ensure the accuracy of all

candidates and determine the eligibility of each candidate

• Complete weekly graphs and charts of workflow of all level two employees in the HR dept

Contact this candidate