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CLINICAL RESEARCH SPECIALIST Resume Example

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CLINICAL RESEARCH SPECIALIST
Experience
January 2006
to
Current
UNC Lineberger Comprehensive Cancer CenterChapel Hill, NC
January 2009
to
Current
CLINICAL RESEARCH SPECIALIST
  • Lead CRA on 16 accruing studies ranging from Phase I to Phase IV Pharmaceutical, Investigator Initiated, and Co-operative Groups for Lung and Head/Neck Cancer Research.
  • Provide back up on 20+ studies.
  • Identify concerning issues, explain procedures, and verify study requirements for Site Initiation Visits.
  • Present data requirements, outline expectations for study Start Ups.
  • Create and maintain a research chart for each treated patient by compiling clinical data from a variety of sources.
  • Complete data forms and resolve data queries for assigned studies.
  • Manage the collection, processing and shipping of blood and tissue samples required for all the clinical trials.
  • Work as a team player with study coordinators, regulatory associates, doctors, nurses, and pharmacists to determine subject eligibility and maintain protocol compliance.
  • Proficient computer skills; adapt to unique electronic data capture & vendor systems such as Medidata, Oracle, OPEN, Inform, Websend, IWRS, and Impala.
  • Additional responsibilities: Review & participate in audits for UNC Investigator Initiated and Cooperative Group trials.
  • Act as Radiation Oncology liaison by retrieving data from Mosiac and resolving RTOG queries.
  • Serve as trainer, system tester, trouble shooter, and user representative at Onsemble conferences for OnCore - the UNC Lineberger clinical research management system.
  • Support role of CRA Super User during medical records system rollover from WebCis to EPIC.
  • Training committee member facilitating programs and training materials to help new hires.
January 2006
to
January 2009
Radiation Oncology DepartmentSOCIAL RESEARCH ASSISTANT
  • This position was created to combine the tasks of a Project Manager with the role & responsibilities of a Clinical Research and Regulatory Associate in the Protocol Office, to support numerous Radiation Oncology Investigator Initiated trials at the Lineberger Comprehensive Cancer Center.
  • Managed the process flow of translational trials by: participating in conferences to identify candidates; scheduling the procedures with other hospital and research divisions; contacting necessary facilities, to collect, prepare, process, evaluate and transplant or test the sample collections.
  • Maintained and enforced Regulatory standards as defined by UNC's IRB, DSMC, IACUC, and DLAM.
  • Reviewed, edited, and prepared materials to be submitted for conferences, grants, and journals.
  • Collected, recorded, and analyzed data containing patient information, sample collection and lab results for research.
  • Served as Honest Broker to maintain research studies' integrity.
  • Established and maintained Material Transfer Agreements with pharmaceutical companies.
  • Monitored participant patient records, coordinated follow up, and collated data to maintain and verify protocol compliance.
  • In addition, headed special projects for the Radiation Oncology Department: Coordinator for the 3rd Annual NC IMRT/IGRT Symposium, prepared materials for continuing education approval from four different oncology associations, acquired sponsorship from vendors (over $24,000), created brochures & programs, managed event set & registration, and processed paperwork for registrants' accreditation.
  • Prepared and submitted grant application for the University Cancer Research Fund on behalf of Dr.
  • David Morris, which received the Clinical Innovation Award in 2008.
January 2005
to
January 2006
Tar Heel Temps, University of North CarolinaChapel Hill, NC
  • Supported Chair by arranging clinical and office schedule, answering incoming departmental calls, organizing work functions / conferences, and reviewing patient charges.
  • Worked on special projects including: creating departmental reference book for the Department Chair Search Committee, determining department budget, analyzing new billing system.
January 2002
to
January 2003
TruePosition, IncKing of Prussia, PAPROJECT MANAGER
  • Directed a team in the planning, installation, and testing of GSM Emergency 911 (E911) location software and equipment onto the Cingular Wireless network for FCC compliance.
  • Scheduled, coordinated, and supervised twenty field technicians for the installation, testing and deployment of TruePosition E911 location software and equipment onto 200 antenna cell sites in and around St.
  • Louis, Missouri and 75 cell sites surrounding Kansas City, Kansas.
  • Met and maintained objectives in a frequently changing environment that reduced the amount of materials and human resources originally defined for the project.
  • Monitored events, analyzed project metrics, and reported weekly to TruePosition senior management and customer on potential problems that could jeopardize meeting the project objectives.
  • Facilitated communications between customer and TruePosition to proactively identify and resolve issues such as system program requirements, technology upgrades, and malfunctioning cell sites.
  • Authored method of procedure documents for cell site access and equipment installation and maintenance/trouble-shooting guide of issues and resolutions for customer.
January 2000
to
January 2002
WorldCom, IncSprings, MOPROJECT MANAGER III
  • Focused on the Marketing initiatives of Digital Subscriber Line (DSL) - championing the needs of Operations Support to ensure the support systems & processes were integrated throughout the company.
  • Managed development projects on variations of DSL service: Asymmetric, Symmetric, Voice, High speed, Ethernet, ISDN, and Rate Adaptive for Operations Support.
  • Worked with Engineering, IT, and users to determine network architecture and provisioning process.
  • Negotiated with internal companies (Rhythms, UUNET, and WorldCom) to re-structure their responsibilities to support installation and turn up, reducing the activation backlog from weeks to days.
  • Developed IT requirements for provisioning, billing, and maintenance and repair trouble reporting systems.
January 1998
to
January 2000
WorldCom, IncTown and Country, MO
January 1999
to
January 2000
PROJECT MANAGER II
January 1998
to
January 1999
SYSTEMS ANALYST
  • Selected as key player on various teams and projects, provided subject matter expertise regarding billing, provisioning, and maintenance systems supporting network based ATM and Frame Relay services.
  • Defined and developed back office system requirements and procedures for parity and future features of legacy MCI and WorldCom ATM and Frame Relay services.
  • Established requirements and priorities of focus for migrations and integration (scope initiation to closure) of systems and networks supporting ATM and Frame Relay services.
  • Managed, tracked, and reported on milestones, issues, and testing of specified ATM and Frame Relay services.
January 1995
to
January 1998
Comcast Cellular Communications, IncWayne, PA
January 1997
to
January 1998
SYSTEMS IMPLEMENTATION MANAGER
  • Supported Marketing, Engineering, and Project Management to successfully launch new products or services.
  • Generated analysis reports and training materials after completing full scale testing of product capability, system compliance, proper billing, and service issues.
  • From 1995-1998 a product or service could not be approved for release without the analysis report from our small group of four people.
  • Developed and implemented new consumer products and services ranging from new digital phones and services to intelligent mediation.
  • Assured that all requirements of assigned projects were managed and fulfilled, then facilitated smooth and productive transitions into the organization by creating detailed documentation and training materials.
  • Wrote and reviewed programming code for vendor systems to interface with existing company technology.
January 1995
to
January 1997
PRODUCT IMPLEMENTATION SPECIALIST
  • Tested and analyzed new products and services to identify actual and potential problems.
  • Advised Project Manager about ramifications of anticipated obstacles to release timeline.
  • Discussed and developed enhancements with vendors, Engineering, and Marketing to define product performance standards.
  • Monitored system adherence to specifications.
  • Compiled testing data, reported comprehensive findings, and provided alternative action recommendations to senior management.
January 1992
to
January 1995
Comcast MetrophoneWayne, PA
  • FEATURES/SERVICES SYSTEMS ANALYST, Customer Service.
  • Served as subject matter expert on service offerings: created training packages and trouble-shooting guides, and trained Customer Service trainers on newly launched features.
  • Designed and managed alert system for special features and service problems, allowing Customer Service representatives to electronically generate trouble report tickets.
  • Resolved trouble tickets and served as point of contact for Engineering.
  • Supported management by handling takeover calls of irate customers, advising representatives, and recommending proactive solutions to declining customer service.
January 1987
to
January 1992
Adventure Shops, IncLima, PA
  • DISTRICT MANAGER, MANAGER, SALES, Halloween Adventure.
  • For two years as District Manager, hired, trained, and supervised staff of approximately forty-five people at four Halloween Adventure stores.
  • As District Manager and Manager, held responsibility for store location, build and set up, overall design and display, purchase orders, distribution of merchandise, maintaining hours of operation, and financial management of stores.
  • For four years generated the highest revenue of company stores.
  • In 1992, stores under my management ranked #1, 2, 4, and 6 out of the sixteen company stores - generating over $500,000 in sales during a three month period.
Education
present
West Chester UniversityChester, PAClinical Research Associate
1987
University of MarylandCollege Park, MDBA: Communications Psychology Journalism, Advertising, and PsychologyCommunications Psychology Journalism, Advertising, and Psychology Publications Cosmetic outcomes for accelerated partial breast irradiation before surgical excision of early-stage breast cancer using single-dose intraoperative radiotherapy. Kimple RJ, Klauber-DeMore N, Kuzmiak CM, Pavic D, Lian J, Livasy CA, Esler L, Moore DT, Sartor CI, Ollila DW. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):400-7. doi: 10.1016/j.ijrobp.2009.10.032. Epub 2010 Apr 13.
Skills
ATM, back up, billing, billing system, book, brochures, budget, CA, conferences, Customer Service, documentation, DSL, Digital Subscriber Line, Ethernet, senior management, FEATURES, financial management, focus, forms, Frame Relay, grants, GSM, human resources, Innovation, ISDN, Marketing, materials, mediation, access, Office, network architecture, network, networks, Oracle, organizing, processes, programming, Project Management, Publications, reporting, Research, SALES, scheduling, shipping, Symposium, SYSTEMS ANALYST, team player, phones, trainer, training materials, trouble-shooting, unique, upgrades
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Resume Overview

Companies Worked For:

  • UNC Lineberger Comprehensive Cancer Center
  • Radiation Oncology Department
  • Tar Heel Temps, University of North Carolina
  • TruePosition, Inc
  • WorldCom, Inc
  • Comcast Cellular Communications, Inc
  • Comcast Metrophone
  • Adventure Shops, Inc

School Attended

  • West Chester University
  • University of Maryland

Job Titles Held:

  • CLINICAL RESEARCH SPECIALIST
  • SOCIAL RESEARCH ASSISTANT
  • PROJECT MANAGER
  • PROJECT MANAGER III
  • PROJECT MANAGER II
  • SYSTEMS ANALYST
  • SYSTEMS IMPLEMENTATION MANAGER
  • PRODUCT IMPLEMENTATION SPECIALIST

Degrees

  • Clinical Research Associate
    BA : Communications Psychology Journalism, Advertising, and Psychology

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