Quality Assurance Manager
Resume:
Nancy D. Resmini, CCRC, CEM
Arlington, Texas 76002
Curriculum Vitae
SUMMARY OF EXPERIENCE:
Twenty years’ of experience conducting clinical trials as a Senior Clinical Enrollment Manager, Clinical Research
Associate, Certified Clinical Research Coordinator, Site Manager, Monitor Consultant for Clinical Research
Companies, Trainer of Research Coordinators, EDC Trainer, Team Lead, Supervisor of Clinical Research,
Senior Quality Assurance Lead and SOP site writing. Twenty years’ of experience detailing organizational
skills to handle multiple ongoing projects. Twenty years’ of handling 20 or more Clinical Research Sites,
Research Studies, Consulting and FDA audits. Knowledgeable of all updated FDA guidelines, regulations
governing Sponsors, CRO’s and clinical research. Experience knowledge of all updated GCP/ICH guidelines
and regulations. Twenty years’ of Reliable reputation among the Sponsor’s, CRO’s, Co Workers, Site staff and
Physicians. Twenty years’ of experience in all phases of Clinical Studies. Twelve years’ experience providing
on site recruitment and spirometry training support to sites. Experience a working relationship with the
Sponsors, CRO’s and clinic sites. Three years of experience in helping Clinical Sites enhance enrollment
opportunities, and to focus on improvement of increasing their recruitment goals.
THERAPEUTIC AREA EXPERTISE:
Significant experience in Hypertension, COPD, Diabetes, Cholesterol, Triglycerides, Prostate Cancer, Kidney
Disease, Asthma, Allergies, Auto Immune Disease, Ankle Sprain, Pain Management, Cardiology, Atrial
Fibrillation, Pediatric H1N1, Erectile Dysfunction, Antigen Cells, Renal Carcinoma, Uveitis Implant, Retina
Disease, Bone Cancer, Osteoporosis, Laser Coagulation, Sub Macular Disease, Obesity, Enrollment Specialist
and Retention Specialist.
PROFESSIONAL EXPERIENCE:
PAREXEL INTERNATIONAL
SENIOR CLINICAL ENROLLMENT MANAGER 2013 to 2014
Reports to: CPS Manager
Works closely with: Principal Investigator, Sub Investigators, Study Coordinators, Recruiters, Study Nurses,
LFT Specialist, CRA’s, CMA’s and Patients.
Responsibilities:
• Maintain updated patient database plus regular site contact and visits.
• Collaborate and exchange information with site staff on a regular basis.
• Collaborate and exchange information with CRAs (as appropriate) on a regular basis.
• Identify opportunities for the LES service to be offered, through an appreciation of the sites’ needs,
awareness of the enrolment needs, information arising out of site meetings.
• Contribute to the development and maintenance of an effective patient database.
• Review patient notes, select and present high quality, patients to fulfil enrolment needs.
• Review site screening records to identify potential subjects. Work with local centres to facilitate a patient
referral process to main centres
• Supply (and coordinate) information for brochures, newsletters, proposals and advertisements concerning
the study recruitment.
• Organise spirometry training and co ordinate other appropriate trainings in co operation with site staff to
ensure continuous development.
Nancy Resmini, CCRC CV Version Date:
23March2014
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Nancy D. Resmini, CCRC, CEM
611 East Lynn Creek Drive
Arlington, Texas 76002
Curriculum Vitae
• Undertake the full range of duties relevant to the LES to ensure that performance meets and/or exceeds the
enrolment for the study.
• Maintain a positive, results oriented work environment, building partnerships and modeling teamwork,
communicating to the site staff in an open, balanced and objective manner.
• Fixed period of support to the data cleaning activities
• Maintains updated Regulatory documents and Informed Consents with all sites.
Blue Chip Marketing Company
Senior Clinical Enrollment Specialist/ CRA/Senior Retention Specialist 2012 to 2012
• Maintain updated patient database plus regular site contact and visits.
• Collaborate and exchange information with site staff on a regular basis.
• Collaborate and exchange information with CRAs (as appropriate) on a regular basis.
• Identify opportunities for the LES service to be offered, through an appreciation of the sites’ needs,
awareness of the enrolment needs, information arising out of site meetings.
• Contribute to the development and maintenance of an effective patient database.
• Review patient notes, select and present high quality, patients to fulfil enrollment needs.
• Review site screening records to identify potential subjects.
• Supply (and coordinate) information for brochures, newsletters, proposals and advertisements concerning
the study recruitment.
• Organise spirometry training and co ordinate other appropriate trainings in co operation with site staff to
ensure continuous development.
• Undertake the full range of duties relevant to the LES to ensure that performance meets and/or exceeds the
enrolment for the study.
• Maintain a positive, results oriented work environment, building partnerships and modeling teamwork,
communicating to the site staff in an open, balanced and objective manner.
• Fixed period of support to the data cleaning activities
• Maintains updated Regulatory documents and Informed Consents with all sites.
• To perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs.
• Performing clinical on site monitoring activities
• Drive Patient Recruitment
• Source data verification
• Drug Accountability
• Data Collection
• Collecting Regulatory Documentation
• Site qualification and initiation of Investigator Sites
• Monitoring and termination of investigator sites in accordance with ICH GCP guidelines.
Discovery Clinical Trials/Dr. Michael Dao Clinical Research Site
Manager/CRA/Senior Quality Assurance Consultant 2010 to 2012
• Maintain updated patient database plus regular site contact and visits.
• Collaborate and exchange information with site staff on a regular basis.
• Contribute to the development and maintenance of an effective patient database.
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Nancy D. Resmini, CCRC, CEM
611 East Lynn Creek Drive
Arlington, Texas 76002
Curriculum Vitae
• Review patient notes, select and present high quality, patients to fulfil enrollment needs.
• Review site screening records to identify potential subjects.
• Supply (and coordinate) information for brochures, newsletters, proposals and advertisements concerning
the study recruitment.
• Organise spirometry training and co ordinate other appropriate trainings in co operation with site staff to
ensure continuous development.
• Undertake the full range of duties relevant to the LES to ensure that performance meets and/or exceeds the
enrolment for the study.
• Maintain a positive, results oriented work environment, building partnerships and modeling teamwork,
communicating to the site staff in an open, balanced and objective manner.
• Fixed period of support to the data cleaning activities
• Maintains updated Regulatory documents and Informed Consents with all sites.
• To perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs.
• Managed 6 Clinical Trials
• Managed 12 Clinical Sites
• Performing clinical on site monitoring activities
• Drive Patient Recruitment
• Source data verification
• Drug Accountability
• Data Collection
• Collecting Regulatory Documentation
• Site qualification and initiation of Investigator Sites
• Monitoring and termination of investigator sites in accordance with ICH GCP guidelines.
• Ensured all sites were in compliance with the FDA regulatory requirements and Good Clinical Practices
• Monitored sites tracking and reviewing regulatory documents
• Reviewed data in source documents for accuracy and completion
• Maintains updated Regulatory documents and Informed Consents with all sites.
• Resolved queries before and within the sponsor time frame
• Creation of standard of Operating Procedures, forms, and operational standards
Dallas Allergy, Immunology Research Dallas, TX 2005 2010
Team Lead/CRA/Associate Monitor Consultant/Senior Quality Assurance
• Team lead on Immunology Study
• Monitor Consultant for Study Trials
• Managed 6 clinical trials
• Maintained updated Regulatory documents and Informed Consents for all studies.
• In compliance with the FDA regulatory requirements and Good Clinical Practices
• Reported all AE’s and SAE’s in a timely manner and follow up activities are conducted as necessary
• Resolved all queries before and within the sponsor time frame
• Monitoring of enrollment patients
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Nancy D. Resmini, CCRC, CEM
611 East Lynn Creek Drive
Arlington, Texas 76002
Curriculum Vitae
• Quality of data accuracy and completion of source documentation and EDC
• Verified subjects safety and site adherence to FDA regulations and GCP/ICH Guidelines
• Acquired specific clinical and therapeutic knowledge related to studies monitored
• Worked with initiation, Interim an Close out Monitoring Visits
• Present Clinical Trial time line to study team
• Prepare for and respond to Sponsor/CRO or FDA Audits
• Collaborate and exchange information with site staff on a regular basis.
• Contribute to the development and maintenance of an effective patient database.
• Review patient notes, select and present high quality, patients to fulfil enrollment needs.
• Review site screening records to identify potential subjects.
• Organise spirometry training and co ordinate other appropriate trainings in co operation with site
staff to ensure continuous development.
• Maintain a positive, results oriented work environment, modeling teamwork, communicating to the
site staff in an open, balanced and objective manner.
• Maintain support to the data clean up
• Maintain updated Regulatory documents and Informed Consents
• To perform the clinical monitoring in accordance with applicable SOPs.
• Performing clinical on site monitoring activities
• Drive Patient Recruitment with all staff
• Source data verification
• Drug Accountability
• Data Collection
• Review Regulatory Documentation
• Ensured all sites staff are trained in compliance with the FDA regulatory requirements and Good
Clinical Practices
• Monitored site staff tracking and reviewing regulatory documents
• Monitor site staff data in source documents for accuracy and completion
• Training site staff on Regulatory documents and Informed Consents with all sites.
• Training staff on resolving queries before and within the sponsor time frame
• Creation of standard of Operating Procedures, forms, and operational standards
Retina Consultants, Fort Worth, TX 2004 2005
Team Lead/Fundus Photographer
• Ensured all Fundus Photography was accurately performed for studies and office visits
• Performed Medical History and work ups on all patients
• PPD 30ml injections on patients over a 10 minute period
• Scheduled Surgeries
• Reviewed information with patients about procedures
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Nancy D. Resmini, CCRC, CEM
611 East Lynn Creek Drive
Arlington, Texas 76002
Curriculum Vitae
Urology Associates of North Texas Fort Worth, TX 2002 2004
Team Lead/CRA/Quality Assurance /Monitor Consultant
• Leadership and training of clinic team
• Monitored Coordinator Studies for quality accuracy
• Train staff site on all aspects of Clinical Research studies
• Ensured all site staff are trained in compliance with the FDA regulatory requirements and Good
Clinical Practices
• Monitored site staff’s source documents for accuracy
• Reviewing regulatory documents for all studies
• Compare data in source documents to Electronic Data Capture for accuracy and completion
• Train site staff on completing Informed Consents accurately
• Train site staff on resolving queries before and within the sponsor time frame
• Train site staff on accuracy of drug accountability on all trials
• Creation of Standard of Operating Procedures, forms, and operational standards
• Train site staff on compliance with the FDA regulatory requirements and Good Clinical Practices
• Report all AE’s and SAE’s in a timely manner and follow up activities are conducted as necessary
• Acquired specific clinical and therapeutic knowledge related to studies monitored
• Present Clinical Trial time line to study team
• Prepare for and respond to Sponsor/CRO or FDA Audits
• Collaborate and exchange information with site staff on a regular basis.
• Contribute to the development and maintenance of an effective patient database.
• Review with site staff patient notes, select and present high quality, patients to fulfil enrollment
needs.
• Review with site staff screening records to identify potential subjects.
• Organise spirometry training and co ordinate other appropriate trainings in co operation with site
staff to ensure continuous development.
• Maintain a positive, results oriented work environment, modeling teamwork, communicating to the
site staff in an open, balanced and objective manner.
• Maintain support to the data clean up
• To perform clinical monitoring of site staff trials in accordance with applicable SOPs.
• Train site staff on how to drive patient recruitment beyond the goal
Minimum Work Experience:
• Current CCRC with COPD background
• Site Manager
• Site Trainer
• Spirometry Trainer/Lung Function Trainer
• Experience in Auto Immune Disease Trials
• Experience in all study trial phases (I IV)
• Experience in Phase I H1N1 study for babies
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Nancy D. Resmini, CCRC, CEM
611 East Lynn Creek Drive
Arlington, Texas 76002
Curriculum Vitae
Skills:
• Excellent interpersonal, written and verbal communication skills including experience of making
presentations.
• Proficiency in Microsoft Word, Excel, power point and Outlook.
• Stay on task with all assignments
• Excellent in organizational skills
• Patient focussed and recruitment awareness, to be able to interact effectively.
• A flexible attitude to work assignments and travel extensively within specified country
• The ability to manage multiple and varied tasks with enthusiasm and prioritise work load with
attention to detail.
• ICH/GCP trained
Advantageous Experience:
• Knowledge of the Pharmaceutical /Clinical Research industries
• Senior Clinical Enrollment Manager
• Experience in spirometry training
• Experience in dealing with low recruitment; Sites meet goals
• Experience with handling data queries and data clean up
• Experience with Regulatory Documents and Informed Consents
• Experienced with Auto Immune Disease
• Experienced with H1N1 Disease
• Senior Quality Assurance
• Monitor Consultant
• CRA experience
• Experienced in all Phases of Research (I IV)
• Experience in Monitoring a variety of Clinical Research Studies
• Experience with Allergy Testing
• Experience with Asthma
• Experience in Internal Medicine Trials
• Experience with All areas of Ophthalmology
• Experienced with FDA Audits
EDUCATION:
• To Degree level or equivalent nursing background
• Associates of Applied Science Degree
• Certification for Clinical Research Associates
PROFESSIONAL ASSOCIATIONS:
• Accredited member, Association of Clinical Research Professionals
• Association of Clinical Research Professionals Meet and Greet Committee Leader for the North Texas
Chapter
PUBLICATIONS:
• Arch Ophthalmology. 2004 November; 122(11): 1597 1611 doi: 10.1001/archopht.122.11.1597
2008 by the American Academy of Ophthalmology
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