Registered Nurse
Resume:
Brenda Coldman
**** **** ****** ** 832-***-**** Wk
Missouri City, Texas 774**-***-*** 4887 CL
OBJECTIVE
Established clinical research professional in clinical trial support and management in research with years of practical experience in general healthcare and oncology, seeking a position with a dynamic company that operates exclusively in the areas of healthcare and/or research.
SUMMARY OF SKILLS
• Familiar with Regulatory guidelines such as GCP, FDA, NCI, ICH, IRB, SOP’s. CFR
• Familiar with regulatory compliance issues such as study site identification,
• Maintain logs such as signature and functions logs, screening logs, enrollment logs and financial disclosure logs. Filing of CV’s and 1572‘s.
• Submissions and tracking of protocols, amendments and revisions, notes to file, LOAs. Tracking of CLIA certifications and IRB approval dates.
• Responsible for drug accountability and the informed consent process.
• Reporting of SAE’s internal and external and protocol deviations to the IRB.
• Preparing for internal and external audits and annual reviews.
• Collaborate with monitors, sponsors, physicians, nurses and data managers.
• Staff education and coordination of protocol-specific inpatient and/or outpatient treatment
• Patient assessment, counseling, and education regarding chemotherapy, surgery and radiation
• Detailed documentation skills enhancing record management, case report forms, source documentation and electronic data entry.
• Management skills in oncology research settings
• Skilled in organizing and presentations.
• ECG Equipment Operation
• Computer skilled, including Microsoft Word, Windows, Excel, Access, PowerPoint, Lotus, E-mail, Type 50 WPM
EXPERIENCE
6/27 2011- Present St Luke’s Episcopal Hospital Houston, Texas
Lead Research Nurse Texas Heart institute
Conduct a large population screening study of middle school children in the Houston area
Field Screening Study Execution
Screening participant check-in, ID verification, and check-out
Assist as needed with pediatric assent process
Assist participant with preparation for ECG
Operate ECG instrument and control data acquisition quality
Obtain ECG per established procedures and protocols
Update screening register; communicate scheduling issues
Protect screening data integrity and transmit to central storage per established procedures.
ECG Equipment Operation
Daily facility opening and closing for the duration of field screening activities.
All equipment functional and quality management checks per established protocols.
Make equipment ready for relocation as required.
1/14/ 2011- 4/30/11 M. D. Anderson Cancer Center Houston, Texas
Senior Research Nurse: Palliative Care
• Senior Research Nurse
• Screen patients for protocol eligibility and manage patient participation in clinical trials
• Coordinate clinic visits, chart review and diagnostic test, and monitoring patient treatment
• Monitor, grade, document, and report adverse events and tumor response
• Identify patient recruitment methods
• Design research instruments and data analysis
2008 – 1/14/ 2011 2011 M. D. Anderson Cancer Center Houston, Texas
Research Nurse Manager: Palliative Care
- Create and publish standard operative procedures for Research Nurses and Data Managers and research operations.
- Clinical Trials Data collection and Data entry into protocol data management database.
Supervision of Research Nurses, Data Managers, Data Analyst, Clinical Studies Coordinator, Data Managers.
- Assign responsibilities and activities within the research team in accordance with individual strengths and expertise.
- Oversee activities of the research team in order to provide guidance, correction when needed, and coverage when short-staffed.
- Complete routine personnel paperwork, such as performance evaluations, and provide performance counseling.
- Coordinate the training and development of personnel.
- Communicate and administer department and institutional policies and procedures.
- Serve as information resource for the research team
2005-2008
Manager Clinical Protocol Administrations:
- Clinical protocol development and management
- Provide oversight and coordination of all clinical protocol initiatives and the protocol management activities handled by the clinical research regulatory group.
- Oversee the submission of new protocols, the revision of existing protocols, and editing of informed consent forms to be protocol-specific.
- Ensure the maintenance of and enhancements/improvements to a database of departmental clinical protocols.
- Ensure the maintenance and improvement of the protocol reference file system as an effective means of maintaining, storing, retrieving, and accessing up-to-date protocols, correspondence, etc.
- Develop and manage the departmental system, policies, and procedures that affect submission, review, approval, and activation, regulation, tracking, and reporting of protocols.
- Manage research activities related to implementation of clinical trials and regulatory compliance.
- Coordinate audits of systems and practices to ensure quality and regulatory compliance.
- Supervise the collection of data and oversee the preparation of scheduled status reports describing interim data, using the Patient Data Management System (PDMS).
- Ensure the preparation and submission of timely Serious Adverse Event reports to the IRB.
- Supervise and assist with protocol annual review process and IND/IDE status reports by ensuring the provision of response and toxicity information on assigned protocols.
- Assist clinical monitors to find study-related information.
- Coordinate site initiation visits for all new industry-sponsored clinical trials.
- Prompt staff to anticipate and meet deadlines for protocol processing.
- Function as liaison between regulatory group and research nursing group.
- Serve on department committees.
• THNMO Trials Committee (TTC)
• Quality Assurance Subcommittee of TTC Personnel Management
Coordination of regulatory correspondence on all departmental clinical research studies.
- Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., Surveillance Committee, IRB) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration).
- Ensure the completion of forms and compliance with institutional, state, and/or federal regulations for study initiation, conduct, and termination.
- Coordinate outgoing material and correspondence to institutional, state, and/or federal agencies.
- Oversee preparation of reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, semiannually, and annually for NCI studies.
- Inform sponsors and collaborators of regulatory status of protocols at least monthly in formal departmental protocol review meetings.
- Ensure the preparation of specific protocol reports and analyses to assist study investigators in the preparation of manuscripts and grants.
- Oversee the preparation of summaries regarding the progress, goals, and objectives of clinical research studies for annual reports and/or final reports
Supervision of protocol regulatory group personnel.
- Assign responsibilities and activities within the regulatory office in accordance with individual strengths and expertise.
- Oversee activities of regulatory personnel in order to provide guidance, correction when needed, and coverage when short-staffed.
- Complete routine personnel paperwork, such as performance evaluations, and provide performance counseling.
- Coordinate the training and development of personnel.
- Communicate and administer department and institutional policies and procedures.
- Serve as information resource for regulatory personnel.
1996 – 2005 M. D. Anderson Cancer Center Houston, Texas
• Research Nurse Supervisor- Management of 25 research nurses and 11 data managers.
• Provided training and development of Research Nurses and other research personnel in the department of Thoracic, Head and Neck and Chemoprevention
• Collaborate with the physician and protocol sponsor regarding protocol design, implementation, and evaluations.
• Design research instruments and data analysis
• Creation of process improvement plans to include en electronic data base to capture daily and weekly activities of the research nurses and data managers associated with clinical trials.
• Review Budget and Cost Analysis of clinical trials
• Data entry, monitoring data, and data corrections via CRF, eCRF
• Administer employee evaluations and encourage t employee advancement.
1995 – 1996 Helix IV Infusion Therapy Houston, Texas
• Home Healthcare field nurse
• Insertion and monitoring of intravenous catheters for home infusion therapy
• Medicare, Medicaid assessments and documentation
• Independently plan and schedule patient visits.
1993-1995 M. D. Anderson Cancer Center Houston, Texas
• Senior Research Nurse
• Screen patients for protocol eligibility and manage patient participation in clinical trials
• Coordinate clinic visits, chart review and diagnostic test, and monitoring patient treatment
• Monitor, grade, document, and report adverse events and tumor response
• Identify patient recruitment methods
• Design research instruments and data analysis
• Provided training and development of research nurses.
1991 – 1993 Lubbock Independent School District Lubbock, Texas
• School Nurse
• Oversee health needs of elementary and secondary students and faculty
• Vision and hearing screening
• Collection and tracking of immunization records
• Health Education to students and staff
1980 – 1991 M. D. Anderson Cancer Center Houston, Texas
• Oncology Clinical Nurse in the following areas.
o Charge Nurse- Medical/Surgical Oncology-Monitored daily clinical operation of assigned LVNs and nurses assistants in the area of head and neck surgery. Created and implemented patient care plans. Medication administration per standard operative procedures. Staff education.
o Staff Nurse -Intensive Care –Implemented homodynamic patient care to the critically ill patient including ventilators, intravenous infusions, telemetry etc...
o Team Leader-Operating Room. GYN – Responsible for timely placement of patient and room set up for patient GYN surgery. Collaboration with physicians and their needs in the operating room. Ability to circulate and scrub duties. Implementation of OR documentation.
Credentials
1980 -Board Examination
1980- BSN License, State of Texas
2001 -Certified Clinical Research Professional
2004- MBA, HCM
Education
1980 Bachelor of Science in Nursing
Prairie View A&M University, Prairie View, Texas
2004 Masters in Business Administration with a focus in Healthcare Management.
University of Phoenix, Phoenix Arizona
Affiliations
Society of Clinical Research Association (SOCRA)
Nursing Society of Clinical Oncology (OCN)
Accomplishments
Co-authored in the publishing of abstracts submitted for the American Society of Clinical Oncology
• Phase I Trial of Oral Green Tea in Adults with Solid Tumors
• Topotecan. Paclitaxel Altering with Etopiside./Cisplatin and Thoracic Radiation in patient with Limited Small Cell Lung Cancer
• Oral TAC-101 in Patients with Advance Malignancies
• Successful Educational PowerPoint Presentations
• Poster Presentations
• Article writing
Community Service
Community Glaucoma Screening associated with the Light House for the Blind Houston, Texas
Children’s Wellness Examinations and Health Fair for the Nehemiah Neighborhood Center Houston, Texas
Collaboration with Minority Coalition Groups for clinical Trials Recruitment
Community Health Fairs Churches, schools, Houston, Texas
References
Available Upon Request
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