Kendra Sanders, MBA

*** **** **** *****

Norcross, Georgia

404-***-**** aca7ir@r.postjobfree.com

Profile: Experienced Clinical Research Coordinator qualified with over 5 years of

visible achievements in clinical trials of Orthopaedics, Oncology, and Hematology research.

Combined resourcefulness, problem solving skills, and clinical knowledge to consistently

deliver improved research and production results. Team player dedicated to quality,

continuous improvement and bottom line objectives.

QUALIFICATION HIGHLIGHTS

Knowledgeable in all areas of research including budgeting, GCP, IRB protocol

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submissions, on going regulatory and IRB phases and IND safety reporting.

Demonstrate competencies in managing clinical trials data, formulating source

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documents and data collection charts and severe adverse event reporting.

Outstanding interpersonal skills; equally comfortable communicating one on one or

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addressing large audiences. Solid ability to translate technical information and

effective communication to staff, physicians and patients.

Committed to quality patient care; frequently recognized by physicians for strict

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attention to detail, patient advocacy and decision making ability in critical

situations.

Performs all job responsibilities in accordance with standards of Good Clinical

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Practice, CNS Standard Operating Procedures (SOP’s), QA/QC procedures, OSHA

guidelines and other state and local regulations where applicable.

CAREER HISTORY

Clinical Research Coordinator (November 2011 September 2013) Orthopaedic

Trauma Study, The Geneva Foundation, Grady/ Atlanta Medical Center Atlanta,

Georgia

Promote safety and confidentiality of research subjects at all times

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Cognizant of and adhere to all applicable regulations and guidelines

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Responsible for data collection and management

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Perform research and development duties that assist current programs managed or

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developed to help insure work efforts are successful

Maintain a collaborative research environment between the site personnel, research

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participants, The Geneva Foundation and the funding organization

Maintain research study administrative, logistical, technical and data management

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functions, following proper security measures where appropriate

Maintain the physical security of the research office space and equipment to include

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key control

Demonstrate proficiency in performing study related procedures as required

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Assist in the preparation of all required technical progress reports

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Maintain and update files of all applicable regulatory documentation for IRB

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(including protocols, approvals, amendments, modifications, etc.) as well as any

communications with the sponsor or any other Federal or regulatory office (including

prior approvals change in scope, etc.)

Clinical Research Coordinator (November 2008 September 2010)

Emory University, Emory Children’s Center Atlanta, Georgia

Recruit research participants for new and existing cancer and hematology studies.

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Coordinate and schedule patient visits and determine eligibility and consent

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patients according to protocol requirements.

Serve as primary contact for monitor site visits and sponsors.

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Evaluate patient eligibility for Phase I, Phase II, and Phase III hemophilia clinical

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trials conducted at both Emory and Children’s Healthcare of Atlanta.

Interface with research participants, determines eligibility and consent patients

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according to protocol requirements.

To develop consent forms, synopses, and coordinate the approval process of clinical

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studies through the designated regulatory approval systems.

Supervise collection of study specimens and processing.

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Assess, grade, document and record clinical toxicities and adverse events according

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to protocol specific grading criteria and in the context of the clinical trial and patient

history and physical status.

Submit reports of serious adverse events to the Sponsor, IRB, and other agencies as

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required per protocol and federal and institutional guidelines.

Ensure compliance with research protocols, review case report forms and audits for

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accuracy with source documents, and attend monitoring meetings with Sponsors.

To develop the research aspects of budgets for sponsored trials and coordinate the

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approval process for Clinical Trial Agreements through the designated systems in

conjunction with the Director, PI, and Research Manager.

Manage research project databases, develop flow sheets and other study related

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documents, and complete source documentation.

Assists in preparation of internal budgets for Emory and CHOA and route the

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documents through the University.

Establish case packages for study procedures, monitor scheduling of procedures and

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charges, as well as coordinate other services necessary.

Obtain charges CPT/CDM codes and review billing for payments.

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Perform SiteMinder entry, sponsor templates for budget and clinical trials

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agreement for all clinical trials.

Clinical Research Coordinator (June 2007 November 2008)

Emory University, Winship Cancer Institute, Atlanta, Georgia 30322

Tracks patients off study and provide clinical coordination of follow up data.

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Provide questionnaires and research documents to potential patients.

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Assists with implementation of protocols.

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Collaborate with healthcare professionals.

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Collect data in a clinical setting.

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Charts documentation and review data as it relates to studies or trials.

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Fulfill other job requirements as appropriate and as directed.

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Respond to data queries, requests for additional information, and data collection and

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submission requirements.

Create forms to track and collect patient financial data.

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Conduct patient screening to determine eligibility and compliance

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Collect and process lab specimens

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Complete flow sheets, case report forms, and other data collection instruments as

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needed and as appropriate for the specific protocols, in association with other team

members

Assess, grade, document and record clinical toxicities and adverse events according

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to protocol specific grading criteria and in the context of the clinical trial and patient

history and physical status.

Submit reports of serious adverse events to the Sponsor, IRB, and other agencies as

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required per protocol and federal and institutional guidelines

Coordinate communication between physicians, mid level providers, other clinical

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staff, sponsoring agencies, and patients/families involved in clinical trials, as well as

between other team members and clinical research staff.

RELATED EXPERIENCE

Volunteered with Winship Cancer Institute performing tasks such as, greeting and

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providing hospitable services to patients and staff entering the building, as well as,

directions to navigate the building for appointments.

Additionally, I volunteered within the Clinical Trials area under the direction of

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Jane Clark, performing duties such as, data entry, SAEs, and organized case study

and clerical responsibilities needed to support various projects.

Volunteered throughout the school year with the Hospitality Committee and the

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School Improvement Committee, completing various tasks to promote an improved

school atmosphere

Volunteered for University Home Health Agency from May July 2005 with a number

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of responsibilities such as, filing, data entry, clinical research, and budget planning,

as well as customer relations

EDUCATIONAL ACHIEVEMENTS, CERTIFICATIONS & SKILLS

University of Phoenix, Atlanta, Georgia 30350

Master of Business Administration/ Health Care Management (2005)

Georgia State University, Atlanta, Georgia 30302

(Major: Biology Minor: Chemistry) Bachelor of Science Degree in Biology, (2002)

A.R. Johnson Health Science and Engineering High School, Augusta, Georgia 30909

Academic Diploma, Specialization in Public Health, (1996)

COMMENDATIONS & HONORS

National Dean’s List Honoree from 2001 2002

Paraprofessional of the year in 2004

Contact this candidate