Project Quality Control
Resume:
Roslyn Parker
Phone: 919-***-****
Durham NC 27703
Email: *******@***.***
SUMMARY
I am organized and detail oriented with the ability to multi task. I am looking to learn, grow, develop, and advance my career. I am team oriented with the ability to grasp new concepts easily. I am eager to face new challenges and conquer obstacles. Ideally, I am looking to secure a leadership position with a well-established organization in a stable environment, with possible telecommuting options, that will lead to a mutually beneficial lasting relationship.
EMPLOYMENT
2016 to Present Operations Specialist
Ruff Estimates, Durham, NC
My job responsibilities include but are not limited to the following:
●Oversee and manage daily business operations and staff
●Maintain and archive records and correspondence for all projects
●Planning, management, and execution of all projects
●Data acquisition and extraction, data analysis, (quantitative and qualitative), data presentation, desk research, marketing review, and planning, and reporting
●Other duties as delegated and defined by company owner
2012 to 2016 Clinical Event Specialist
PPD Inc., Morrisville, NC
My job responsibilities include but are not limited to the following:
●Maintain utmost discretion when dealing with sensitive topics and study data per SOPs & WPDs
●Manage resource allocation for global teams
●Oversee and manage the collection, review, and tracking of event packets submitted by participating clinical trial sites
●Implement procedures for the evaluation of event source documents for completeness, consistency, clinical reliability and validity
●Utilize clinical judgment to assess content and adequacy of source documentation
●Implement quality control processes to ensure that clean event packets are submitted for adjudication
●Develop project documents, including status reports and communication tools, using word processing and spreadsheet presentation
●Interact directly with the sponsor on study specific aspects, as directed by the department head
●Prepare materials for project and sponsor meetings
●Maintain and archive project related correspondence with sponsor and adjudication committee
●Ensures compliance with project budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to appropriate individuals
●Mentor and/or train new or junior Adjudication staff
●Assist with proposals, bid defenses and other presentations
●Perform other related duties as assigned or requested by Adjudication Management
2011 to 2012 Adjudication Lead/CEC Liaison
PPD Inc., Morrisville, NC
My job responsibilities include but are not limited to the following:
●Provide employee support and guidance
●Communicate effectively with CEC members, site staff, and other team members regarding study from start up to close out
●Provide feedback to upper management regarding issues within the team and offer valuable solutions
●Delegate training and ensure compliance for onboarding and current employees and assign studies according to project needs
●Allocate employee resources globally for new awards per management request
●Complete budget analysis for projects, provide budgets to employees to ensure compliance
●Utilize Clarity for resource entry, assignments, and tracking
●Provide supervision of the safety administrator support staff and their assigned SAE processing tasks. This includes day-to-day oversight of the assigned support staff, problem solving, assisting with project assignments and coverage, interviewing potential support staff, and conducting performance reviews.
●Continue to maintain and uphold responsibilities of team lead position listed below as required
2010 to 2011 Adjudication Team Lead
PPD Inc, Morrisville, NC
●Electronically collect and review incoming documents for accuracy to ensure good time management of dossier builds
●Build dossiers for review by the committee to determine if adjudication criteria met
●Attend and/or facilitate project team meetings, prepare and distribute meeting minutes and client documents.
●CEC Liaison for committee members for all Adjudication studies
●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.
●Participate in quality control, report distribution, project file creation and maintenance for assigned studies.
●Complete audit readiness process for assigned studies and with preparation of materials for internal and Client audits.
●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 for the Adjudication team
●Set up project specific databases for protocol inquiries, physician assessment diagnostic forms and eligibility review packets.
●Perform data entry of protocol inquiries, diagnostic assessments and eligibility review packets related to Medical Monitor designated projects into project specific tracking databases.
●Prepare proposals, contract modifications, project billing, and budget maintenance.
2009 to 2010 Safety Administrator III
PPD Inc, Morrisville, NC
My job responsibilities include but are not limited to the following:
●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
●Writing narratives and assisting with narrative QC
●Communicate with site staff for case completion accuracy and timeliness
●Perform data entry of site specific information from SAE report forms into safety databases as well as Access and Excel tracking databases.
●Responsible for managing multiple studies from start up to close out
2007 to 2009 Safety Administrator II
PPD Inc, Morrisville, NC
My job responsibilities include, but not limited to, the following:
●Intake, track, and distribute all incoming documents for accuracy and entry into Safety Database
●Utilize Database for entry and management of patient data
●Perform general administrative support for the department including maintenance of supplies and office machines.
●Electronically indexing SAE documents into Electronic imaging system and quality control of scanned documents.
●Compiling SAE case files and allocates to the appropriate safety team for review/processing.
●Electronically distributing documents to the appropriate Medical Monitor for review/processing.
●Electronic distribution of project tracker reports to the Sponsor and project team.
●Responsible for adhering to PPD’s corporate policies and SOPs/WPDs.
EDUCATION
Nov 2008 – Dec 2009 BBA (Suma Cum Laude) in Health Care Management at American Intercontinental University
Oct 2007 – Nov 2008 AABA (Honors) in Health Care Administration at American Intercontinental University
June 2005 - Medical Billing Certification and Clinical Trial Certificatio
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