Fabricio Nunez

• Coordinated clinical trial activities, ensuring compliance with regulatory standards and protocols.
• Managed subject recruitment processes to optimize enrollment and retention rates.
• Oversaw data collection and management, ensuring accuracy and integrity of study information.
• Collaborated with cross-functional teams to streamline trial processes and enhance operational efficiency.
• Trained research staff on protocols, procedures, and best practices to ensure adherence to guidelines.
• Implemented process improvements that enhanced trial operations and reduced turnaround times for results.
• Lead coordinator of Cardiometabolic trials, Vaccine trials, Weight loss trials in different phases.

Lead CRC of 5 studies, back up CRC of 10 studies.

Research Duties.

• IRB Submissions.
• Conducting visits for Spanish-speaking participants.
• Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the course of the study.
• Managed multiple research studies simultaneously while ensuring accurate record keeping.
• Managed study communication with CRO's, Families/Subjects and Sponsors.
• Conducted pre-screening interviews to determine eligibility of possible subjects.
• Obtained Medical records from Subjects/Health facility for eligibility.
• Helped Principal investigator set up to administer informed consent/assent.
• Maintained Investigator Site File binders, adding IRB approved documents, filing updated staff medical licenses/certifications and NTFs.
• Maintained Patient Binders , adding visits CRF's, Lab results, Physical therapy worksheets.
• Updated Participants AE, ConMed, ConProcedure logs when necessary.
• Managing study communication with CRO's, Families/Subjects and Sponsors.
• Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
• Developed case report forms for data collection.
• Verified accuracy of data by conducting quality assurance checks on collected materials.
• Monitored subject enrollment and tracked dropout details.
• Adhered to ALCOA for good documentation practices.
• Adhered to HIPPAA guidelines.
• Adhered to Good clinical practice guidelines.
• Adhered to study specific protocols.
• Adhered to tasks in DOA.
• Entering data in EDC and resolving queries in a timely manner.
• Scheduled participants visits including travel arrangements with Sponsor's travel agencies.
• Scheduled CRA monitoring visits.
• Used DocuSign to document relevant staff training for changes in Protocol.
• Monitored Room temperature for Sample stability.
• Monitored Refrigerators and freezers for sample/ IP stability.

Clinical Duties

• Performed participants Clinical assessments during visits such as recording of Vital signs, Weight, Height and ECG's.
• Collected medical histories as part of study protocols.
• Monitored Patient safety during clinical trials through assessing of AE's/SAE's and concomitant medications.
• Setting up surgical room for muscle biopsy procedures/ assisting PI in processing of sample.
• Assisting Nurse in infusion procedures by helping get IV access and Vital signs recording.
• Oversaw Clinical supplies and placed orders to expand inventory.
• Assisted Nurses during Home health visits in the collection of blood.

Laboratory Duties

• Performed venipuncture and other blood collection procedures according to established standards.
• Collected, processed and delivered specimens from trial participants.
• Ordering Dry Ice for Sample shipment.
• Setting up Laboratory in advance of Participants visits.
• Performing point of care testing such as in house urinalysis.
• Archived Lab results in Participant binders.
• Cleaned and prepared lab equipment for solutions, specimens and samples.
• Kept lab space and equipment clean to prevent contamination with hazardous substances.
• Identified and fixed issues with lab equipment to achieve more accurate lab results.
• Employed scientific methods to promote quality of collected samples and stored specimens.
• Oversaw lab equipment stock and placed orders to expand inventory.
• Disposed of hazardous materials according to established protocols.

Indication Experience

Gastrointestinal- GERD, IBS-D, Nash/Mash

Neurological - Migraines

Vaccines - RSV, FLU, Chikungunya

Immunological - Celiac Disease

Primary CRC and back up CRC/RA of 6 active clinical studies.

Research Duties

• Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the course of the study.
• Managed multiple research studies simultaneously while ensuring accurate record keeping.
• Managed study communication with CRO's, Families/Subjects and Sponsors.
• Conducted pre-screening interviews to determine eligibility of possible subjects.
• Obtained Medical records from Subjects/Health facility for eligibility.
• Helped Principal investigator set up to administer informed consent/assent.
• Maintained Investigator Site File binders, adding IRB approved documents, filing updated staff medical licenses/certifications and NTFs.
• Maintained Patient Binders , adding visits CRF's, Lab results, Physical therapy worksheets.
• Updated Participants AE, ConMed, ConProcedure logs when necessary.
• Managing study communication with CRO's, Families/Subjects and Sponsors.
• Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
• Developed case report forms for data collection.
• Verified accuracy of data by conducting quality assurance checks on collected materials.
• Monitored subject enrollment and tracked dropout details.
• Adhered to ALCOA for good documentation practices.
• Adhered to HIPPAA guidelines.
• Adhered to Good clinical practice guidelines.
• Adhered to study specific protocols.
• Adhered to tasks in DOA.
• Entering data in EDC and resolving queries in a timely manner.
• Scheduled participants visits including travel arrangements with Sponsor's travel agencies.
• Scheduled CRA monitoring visits.
• Used DocuSign to document relevant staff training for changes in Protocol.
• Monitored Room temperature for Sample stability.
• Monitored Refrigerators and freezers for sample/ IP stability.

Clinical Duties

• Performed participants Clinical assessments during visits such as recording of Vital signs, Weight, Height and ECG's.
• Collected medical histories as part of study protocols.
• Monitored Patient safety during clinical trials through assessing of AE's/SAE's and concomitant medications.
• Setting up surgical room for muscle biopsy procedures/ assisting PI in processing of sample.
• Assisting Nurse in infusion procedures by helping get IV access and Vital signs recording.
• Oversaw Clinical supplies and placed orders to expand inventory.
• Assisted Nurses during Home health visits in the collection of blood.

Laboratory Duties

• Performed venipuncture and other blood collection procedures according to established standards.
• Collected, processed and delivered specimens from trial participants.
• Ordering Dry Ice for Sample shipment.
• Setting up Laboratory in advance of Participants visits.
• Performing point of care testing such as in house urinalysis.
• Archived Lab results in Participant binders.
• Cleaned and prepared lab equipment for solutions, specimens and samples.
• Kept lab space and equipment clean to prevent contamination with hazardous substances.
• Identified and fixed issues with lab equipment to achieve more accurate lab results.
• Employed scientific methods to promote quality of collected samples and stored specimens.
• Oversaw lab equipment stock and placed orders to expand inventory.
• Disposed of hazardous materials according to established protocols.

Pharmacy Duties

• Randomizing Participants in IRT.
• Investigational Product dispensing and accountability.
• Notified Participants of known side effects of IP.
• Ordering a new shipment of IP to the site when needed.

Indication Experience

Genetic: Duchenne muscular Dystrophy, Beckers Muscular Dystrophy.

RA of 2 active studies

Research Duties

• Performed data entry, organized and maintained participant records, monitored patient safety and prepared reports.
• Resolve queries in EDC.
• Administered informed consent to participants.
• Tracked interested and enrolled participants on spreadsheet.
• Pre-screened potential participants for eligibility.
• Provided support with the development of case report forms and other study related documents.
• Reviewed medical information from source documents to verify accuracy of CRF entries prior to database lock.
• Educated clinical study participant and addressed concerns.
• Adhered to HIPAA.
• Adhered to ALCOA for good documentation practices.
• Adhered to Study protocol.
• Adhered to Good clinical practices.
• Updated and maintained information accuracy within patient database.
• Scheduled Participants visits, Including travel arrangements.
• Sent Reminder cards of upcoming visits to participants.
• Verified appointment times with patients, preparing charts, pre-admission and consent forms.
• Helped CRC with Patient binder maintenance.

Clinical Duties

• Prepared treatment rooms for patient examinations, including for PAP smears.
• Performed Pulmonary function tests on participants.
• Processed orders for medical supplies and lab equipment.
• Kept facility stocked with necessary supplies, equipment and instruments.
• Assisted in the preparation of laboratory specimens for analysis and testing.

Laboratory Duties

• Performed venipuncture and other blood collection procedures according to established standards.
• Collected, processed and shipped specimens from participants.
• Collected, labeled and stored laboratory specimens properly prior to testing.
• Cleaned and sterilized instruments and disposed of contaminated supplies.
• Assisted in the preparation and maintenance of laboratory equipment and supplies.
• Kept lab space and equipment clean to prevent contamination with hazardous substances.
• Assisted in the preparation of laboratory specimens for analysis and testing.
• Performed Vaginitis Wet mounts.
• Recorded Room, Refrigerated and Frozen temperatures.

Indication Experience

Infectious Disease - HIV

• Assisted in patient care by providing specimen collection, specimen processing, and specimen testing.
• Responsible for providing phlebotomy and specimen collection for outreach programs.
• Processed and package all referred laboratory specimens.
• Maintained specimen tracking logs, receive and disseminate all referred test results.
• Positively identify all patients, verify that patient and requisition information match.
• Perform venipuncture, capillary punctures following all required safety procedures and wearing appropriate PPE as required by policy/procedure.
• Process patient specimens as required.
• Package test specimens appropriately for reference laboratories.
• Maintain adequate supply of stock in the phlebotomy area.
• Monitor stock expiration dates
• Performed laboratory tests such as hemoglobin, hematocrit, and Glucose tests.
• Maintained laboratory equipment in proper condition by conducting regular maintenance checks.
• Entered Data in EPIC the medical record system.
• Observed safety protocols while working with hazardous materials in the lab setting.
• Answered phone calls from patients or other healthcare staff regarding lab services.
• Coordinated prioritization, receipt and delivery of laboratory specimens.
• Identified and corrected problems that could adversely affect test performance or reporting of test results.
• Performed quality control procedures to validate test results according to established standards.
• Followed laboratory guidelines for handling biological specimens.
• Assisted in the preparation of laboratory specimens for analysis and testing.
• Adhered to HIPPA.
• Adhered to Durham/laboratory SOP's.

• Performed venipuncture and other blood collection procedures according to established standards.
• Assisted in the preparation of laboratory specimens for analysis and testing.
• Maintained a clean, safe, and organized work environment.
• Verified patient information prior to specimen collection.
• Educated patients on proper blood draw techniques.
• Provided assistance to clinical staff during patient visits.
• Collected specimens from pediatric, adult, geriatric, and special needs patients.
• Processed samples accurately and efficiently.
• Followed all safety protocols when handling hazardous materials.
• Calibrated equipment according to manufacturer specifications.
• Ensured compliance with federal regulations governing laboratory procedures.
• Monitored inventory levels of supplies used in phlebotomy services.
• Documented patient information into electronic medical records system.
• Prepared specimens for transport to external laboratories.
• Adhered to HIPAA guidelines regarding patient privacy.
• Adhered to UNC/Laboratory SOP's.
• Provided excellent customer service while interacting with patients.
• Assisted in the training of new phlebotomists.
• Performed quality control tests on collected specimens.
• Reported any abnormal results or trends to supervisor or laboratory manager.
• Responded quickly and effectively to emergency situations.
• Located veins suitable for puncture to draw blood using sterilized needles, vials and other equipment.
• Identified patients using proper procedures prior to specimen collection.
• Prepared and packaged specimens for courier transport.
• Entered date in EPIC, the medical record system.

• Performed venipuncture and other blood collection procedures according to established standards.
• Assisted in the preparation of laboratory specimens for analysis and testing.
• Maintained a clean, safe, and organized work environment.
• Verified patient information prior to specimen collection.
• Provided assistance to clinical staff during patient visits.
• Collected specimens from pediatric, adult, geriatric, and special needs patients.
• Processed samples accurately and efficiently.
• Followed all safety protocols when handling hazardous materials.
• Calibrated equipment according to manufacturer specifications.
• Ensured compliance with federal regulations governing laboratory procedures.
• Monitored inventory levels of supplies used in phlebotomy services.
• Documented patient information into electronic medical records system.
• Adhered to HIPAA guidelines regarding patient privacy.
• Provided excellent customer service while interacting with patients.
• Observed patient for unusual reactions or events to take appropriate action under established guidelines.
• Interpreted medical information accurately and effectively between Spanish-speaking patients and healthcare providers.
• Assisted Spanish-speaking patients in understanding their diagnosis and treatment plans.
• Worked with physicians to ensure accurate communication during patient exams.
• Helped facilitate culturally appropriate care for Spanish speaking populations.
• Acted as a cultural bridge between providers and Spanish speaking families regarding health care decisions.