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Clinical Research Manager

Location:
United States
Posted:
December 23, 2019

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Resume:

Robin C. Pope

**** ********* **.

Lewisville, NC 27023

336-***-**** (C)

ada4tv@r.postjobfree.com

EDUCATION:

Guilford Technical Community College, Greensboro, NC

(Graphic Arts)

Surry Community College, Dobson, NC - 1988-1990

(Business Administration)

Graduate Mount Airy High School - Diploma 1988

NC Scholar

LS Starrett Scholarship Award

Ranked 23rd in class

PROFESSIONAL EXPERIENCE:

Novant Health, Corporate Clinical Research, Winston Salem, NC

Position: Clinical Research Coordinator – Cardiovascular/Electrophysiology/Urology/Neuroscience Studies

05/09/2016-Present

Exercise authority and accepts accountability for all research activity and study participant care. Comply with all regulatory requirement related to the conduct of research (FDA, GCP, and IRB). Communicates protocol information to physicians and staff. Schedules and attends study visits. Perform protocol driven procedures as required. Troubleshoots enrollment and study conduct issues. Maintain clinical and professional competency standards. Generate study specific source documents for use in clinical trial data collection. Collect and process information from patient charts, medical records, interviews and appropriate forms. Assesses and reports adverse events in a timely manner. Completes study specific CRF’s and assures appropriate communication with study sponsors. Arranges and attends monitoring visits. Screens incoming research proposals for feasibility. Acts as a preceptor and trainer from coordinator staff in keeping with guidelines. Assures drug and device accountability. Attends study specific investigator meetings as required. Sponsors include (Biotronik, Respicardia, Medtronic, Abbott (formerly St. Judes Medical), Boston Scientific, Chiltern)

Wake Forest University Health Sciences, Winston Salem, NC

Position: Clinical Research Coordinator – Trauma Surgery

03/19/2013-01/06/2014

Worked in the planning and implementation of project(s) of trauma and burn clinical studies. Responsible for assisting with recruitment of patients for clinical research studies. Oversee recruitment, data collection, and follow-up activities. Obtain and interpret pertinent data from medical records as needed to better understand past and present condition of the patients. Responsible for administrative and clerical duties such as designing brochures, stationary and data forms. Assist in development of suitable codes and data collection forms for computerization.

Consult and cooperate with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study. Enter case report forms into databases.

Position: Clinical Research Coordinator - Department of Internal Medicine-Gastroenterology

07/18/11-3/19/2013

Assisted principal investigator and other health professionals in troubleshooting various problems related to the management of clinical studies in biliary, Crohns, and IB studies. Assist in all aspects of the data collection process.

Performed technical procedures on clinical subjects under the direction of the principal investigator or his/her designee. Responsible for assisting with recruitment of patients for the clinical study including tracking the sources of patient referrals. Follow-up with sources of patient referrals including referring doctors, various Medical Center labs, and other sources. Maintained appropriate patient records as necessary. This includes charting the condition of the patient and determining their continued eligibility in the study. Screened potential subjects and verified eligibility and consented subjects. Performed day-to-day administrative and clerical duties such as designing brochures, stationary and data forms. Create reports and graphs pertinent to the study including presentation of the final results of the study.

Prepared data collection forms for electronic and paper case report forms. Consulted and cooperated with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study.

Handled all regulatory IRB related matters for each study.

Outcomes, Inc., Alpharetta, GA

Position: Field Reviewer for North Carolina (Contract work)

10/1/10-05/01/2011

Accurately and efficiently conducted medical record audit services (Blue Cross Blue Shield, United Health Care, Medicare-HEDIS review). Scanned relevant components of the medical record to support reviews performed. Uploaded and scanned medical records daily. Maintained communication lines with Outcomes Health advocate. Successfully completed required training, testing and quality assessments. Communicated effectively and professionally with care provider offices, clinics, hospitals, other clinical facilities. Traveled to medical facilities in specified area of region from home to complete review services Abided by all HIPAA and associated patient confidentiality requirements

Wake Forest University Health Sciences, Winston Salem, NC

Position: Assistant Project Manager- Public Health Sciences-Section on Social Sciences and Health Policy

12/13/04 -8/29/08

Responsibilities:

Responsible for the planning, development, implementation and evaluation of certain phases of the assigned project(s); translate planning and design decisions into concrete activities and tasks to be undertaken and set priorities as appropriate. Prepared and submitted grants/Developed budgets for grant proposals and tracked budgets, contracts and payments. Made sure all invoiceable items were complete. Responsible for ensuring that aspects of the study are conducted in accordance with the study protocol. Handled regulatory/IRB approvals: submissions; renewals; amendments; closures; research and submit new protocols. Developed consent forms and upon receipt of scientific section, complete protocols for new studies. Coordinate recruitment, data collection, and follow-up activities. Monitored and tracked research accounts. Develop projections as requested. Oversee and develop collection methods; create and revise study materials, forms, manuals, and brochures as requested. Scheduled, met, consented and followed up with study participants. Made sure all CRFs were complete. Develop computerized methods for monitoring and reporting on various aspects of the study. Establish and maintain separate billing files on specific accounts related to individual departments/sections during the course of the project. Provided progress reports, FSR’s, and carryovers with grantors. Designed and composed posters for PI review. Prepared and submitted manuscripts according to publisher’s guidelines. Arranged conferences and committee meetings.

Position: Assistant Project Manager - Comprehensive Cancer Center of Wake Forest University CCOP Research Base

9/23/02-12/13/04

Responsibilities:

Responsible for the direct interaction and supervision of the development and coordination of protocols and data collection. Developed data collection methods Coordination of audit and quality assurance data. Assisted Principal Investigators in planning and developing clinical trial protocols. Maintained IRB regulatory files for the clinical research group for NCI funded Research Base Coordinating Center which included 20 clinical community oncology programs within the United States

Position: Clinical Research Associate (CRA) - Comprehensive Cancer Center of Wake Forest University

01/01/01-09/23/02

Responsibilities:

Major Duty: Clinical trial data entry per protocol specific instructions; ensure data collection accuracy and compliance throughout the duration of patient's study treatment. Created and maintained patient's protocol chart by keeping an accurate filing system of pertinent information. Communicated effectively with the Research Base team, Research Base CCOP's and Non-CCOP members, and other internal and external institutions to ensure quality patient care. Collection of protocol data and meticulous maintenance of flow sheets and all study records.

Entry of all data that is required per protocol into database. Report Adverse Events/Serious Adverse Events to appropriate staff and complete all necessary associated documents and reports. Ensured all work is performed efficiently and effectively, query reports are generated to provide quality feedback, by means of query letters in request for data. Assisted with development of Data Management Forms (DMF's). Conducted quality checks on protocols for statistician when notified. Attended professional meetings and the Annual Research Base Meeting to keep abreast of current protocols and protocols in development. Participated in audits as needed.

Position: Administrative Assistant - Comprehensive Cancer Center of Wake Forest University

11/19/99-01/01/01

Responsibilities:

Travel arrangements for 3 faculty members

Maintained yearly calendar for faculty

Scheduled lectures

Word processing (CV's, teaching portfolio, general letters), PowerPoint presentations

Transcription for Doctors of the Comprehensive Cancer Center

Form preparation

Back up for patient bone marrow harvest scheduling

Position: Secretary II - Southeast Cancer Control Consortium

5/19/97-09/99

Responsibilities:

Word Processing compiling, preparing and editing (Microsoft Word, Excel, Word Perfect)

Document/Forms preparation (e.g. consent forms, NCI grant renewal)

Knowledge of medical oncology terminology and familiarized with ICD-9 coding

Dictation of meeting minutes

Queries for URCC (University of Rochester Cancer Center)

Data management files and record maintenance

Entered protocol information into ORIS

Secretarial support for 5 people, general office activities, maintain supplies for general office and office equipment

Prepared grants for submission

Responsible for direct interaction inquiries from CCOP's (Community Clinical Oncology Programs)



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