Sabina Wlazlo Cascalheiro
MORRISVILLE,NC
Summary
Experienced Clinical Research Coordinator with over 3 years of on-site and remote work experience. Adept at managing complex studies from start-up to close-up. Successfully coordinates 16 projects/studies simultaneously, specializing in Phase I-IV clinical trials in Oncology, Orthopedics, and Medical Devices. Published scientific papers in the prestigious North American Journal of Medical Sciences, as well as projects and poster presentations. Results-oriented individual with exceptional oral and written communication, organizational, and problem-solving skills. Collaborates closely with the Principal Investigators, Sub-Investigators, Study Nurses, Monitors, and study team to recruit, consent, screen, and enroll participants for clinical research studies. Efficiently manages multiple research studies using electronic Data Capture systems for accurate data entry. Works effectively with multiple teams to prepare for subject enrollment. Takes responsibility for preparing kits for research blood draw according to protocol, ordering supplies, and working closely with a study monitor (CRA) and sponsor. Possesses critical thinking and problem-solving skills to effectively manage challenging situations and handle meetings. Manages regulatory documents, receives and dispenses Investigational Product (IP) per protocol, and monitors potential IP temperature excursions. Proactively schedules and coordinates subject visits as well as payments. Interacts seamlessly with multidisciplinary, multilingual, and cross-cultural health professionals and patients/clients in the clinical setting. A versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples, and compliance documents for diverse clinical trials. Highly organized and thorough with excellent planning and problem-solving abilities. Utilizes analytical skills to identify data or patient safety issues.
Overview
9
9
years of professional experience
Work History
Clinical Research Coordinator Managing 16 Studies
Duke Cancer Institute, GI Oncology
03.2022 - Current
- Work closely with Principal Investigators, Sub-Investigators, Study Nurses, Study Sponsors, Monitors, Finance team
- Research Study start-up trough close-up, 16 studies simultaneously
- Perform recruitment, consents, screen, and enroll participants, collect and data completion
- Prepare kits for research blood draw assigned for each visit per protocol, order supplies
- Managed regulatory documents
- Communicate effectively with sponsors in timely manner, manage and schedule monitor's and audit onsite/remote visits
- Keep subjects files with the standards of GCP.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Followed informed consent processes and maintained records.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Reviewed referral information and kept track of intakes from various referral sources.
- Facilitated focus group sessions with project patients.
Clinical Research Coordinator, Spanish Interpreter
Wake Research, M3 Emerging Medical Research
04.2021 - 03.2022
- Work closely with Principle Investigators
- Study monitors, and Sponsors
- Perform Inform Consent, data entry, screening subjects/clients, scheduling, and issue payments
- Maintaining regulatory binders, case report forms, charts, and regulatory documents
- In charge of drug accountability, second verifier, and an injector in COVID19 vaccine study.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Reviewed referral information and kept track of intakes from various referral sources.
- Collected, evaluated, and modeled collected data.
- Interpreted conversations simultaneously to help both parties conduct business, handle medical needs or manage personal concerns.
- Interpreted spoken and written languages other than English and vice versa.
- Interpreted conversations between foreign language-speaking clients and others.
Physical Therapy Tech, Spanish Interpreter
EmergeOrtho
02.2018 - 04.2021
- Assist Licensed Physical Therapist with the supervision of exercise programs and the administration of modality treatments
- Coordinates of Wellness aquatic exercise program for geriatric patients.
- Spanish interpreter during Physical Therapy visits of various specializations.
- Facilitated communication between law enforcement personnel and individuals involved in crimes such as witnesses, persons of interest, and suspects.
- Maintained message content, tone, and emotion as closely as possible.
- Stayed current on new expressions and cultural changes impacting language translation.
- Assisted foreign language-speaking clients with inquiries.
- Interpreted conversations simultaneously to help both parties conduct business, handle medical needs or manage personal concerns.
- Interpreted conversations between foreign language-speaking clients and others.
- Interpreted spoken and written languages other than English and vice versa.
Physical Therapy Observation
Duke University Hospital, Spine Clinic Outpatient
01.2017 - 01.2018
- Shadow the Licensed Physical Therapist during treatments and exercises
- Assisting patient's recover from mobility limitations and injuries
- Develop personalized treatment plans
- Increase mobility and educate with appropriate exercise techniques to improve their health at outpatient setting.
- Observed and recorded patients' responses to therapies and exercises to report to practitioners and recommend adjustments to treatment plans.
- Adapted therapy sessions and exercises according to patient progress and limitations.
- Taught patients how to use braces, crutches, and prosthetic devices to reduce pain.
- Discussed rehabilitation and reconditioning options to improve patients' function and quality of life.
- Educated patients on proper body mechanics and injury prevention to avoid risk of re-injury.
- Administered sports injury rehabilitation, facilitating return to pre-injury levels of activity.
- Utilized evidence-based practices to improve patient outcomes
Rehab Volunteer
WakeMed Hospital
01.2016 - 01.2018
- Assist Licensed Physical Therapist with the supervision of exercise programs
- Administration of modality treatments at inpatient setting.
- Supported engaging, fun, and smooth-running events by helping with organization and planning.
- Maintained clean, neat, and operational facilities to serve program needs.
- Used strong interpersonal communication skills to convey information to others.
- Communicated with staff members to stay informed about volunteer opportunities and events.
- Represented organization positively and professionally while providing community with much-needed services.
- Tracked service activities and outcomes against outlined plans and goals.
- Approached issues proactively to best meet current and future community needs.
Education
BS - Physical Therapy
Campus Academico De Silves, Escola Superior De Saude JeanPiaget De Algarve, Portugal
Silves, Portugal06.2014
Skills
- Microsoft Office, Excel, Powerpoint
- Microsoft Windows
- Adobe Acrobat
- Serious Adverse Event Reporting
- Medidata RAVE
- Good Documentation Practice
- Team Management
- Project Management, for clinical needs and scientific research
- Adaptive to changing environment
- Exceptional communication skills
- Specimen handling
- Trial oversight
Skillshighlights
- Microsoft Office
- Medical Terminology
- Self-motivated
- Telecommunication skills
- Strong planning skills
- Technical expertise
- Public speaking
- Detailed-oriented
Vendorexperience
- Signant (IRT/ IXRS)
- 4G Clinical
- BIOCLINICA/CLARIO
- BioMed
- BioTel
- Cell Carta
- CLARIO IRT
- ERT-eCOA
- ICON iSITE 4
- IMAGING PLATFORM - KEOSYS
- IMedidata (EDC)
- IMedidata RAVE (EDC)
- IWRS
- LABCORP
- MayoClinic
- MEDRIO IRT/EDC
- MG MedNet/images
- PPD PRECLARUS
- SUVODA
- TrialManager
- Wcg trifecta -Investigator Space
- YPrime
Presentations
Effectiveness of static stretching time in improving flexibility in master swim team athletes, Days of Physical Therapy (Universidade Fernando Pessoa, Porto, Portugal)
Gcpciticourses
- Biomedical Research with GCP - Basic/Refresher
- Responsible Conduct of Research - Staff - BASIC
- Vulnerable Subjects - Research Involving Children
- Vulnerable Subjects - Research Involving Pregnant Women, Fetuses, and Neonates
- Vulnerable Subjects - Research Involving Prisoners
Publications
Prevalence of Temporomandibular Disorder in Children and Adolescents from Public Schools in Southern Portugal, North American Journal of Medical Sciences
Timeline
Clinical Research Coordinator Managing 16 Studies
Duke Cancer Institute, GI Oncology
03.2022 - Current
Clinical Research Coordinator, Spanish Interpreter
Wake Research, M3 Emerging Medical Research
04.2021 - 03.2022
Physical Therapy Tech, Spanish Interpreter
EmergeOrtho
02.2018 - 04.2021
Physical Therapy Observation
Duke University Hospital, Spine Clinic Outpatient
01.2017 - 01.2018
Rehab Volunteer
WakeMed Hospital
01.2016 - 01.2018
BS - Physical Therapy
Campus Academico De Silves, Escola Superior De Saude JeanPiaget De Algarve, Portugal
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