Ginna Fominaya-Pardo
Sunrise,United States
Overview
24
24
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Coordinator II
Riverchase Dermatology and Cosmetic Surgery
09.2021 - 09.2023
- Trained new team members on the principles of Good Clinical Practice and ICH regulations.
- Gathered and reviewed study data.
- Conducted pre-study site visits to assess compliance with protocols and applicable regulations.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Served as a liaison between sponsors, investigators, vendors throughout the duration of the study.
- Collected, processed and delivered specimens from trial participants.
- Took vital signs and collected medical histories as part of study protocols.
- Educated participants on studies and anticipated outcomes.
Clinical Research Coordinator I
South Florida Research Institute
01.2020 - 09.2021
- Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
- Monitored patient safety during clinical trials according to established guidelines.
- Collected, processed and delivered specimens from trial participants.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Educated participants on studies and anticipated outcomes.
- Developed case report forms for data collection at investigational sites.
- Conducted screening interviews to determine eligibility of possible subjects.
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Gathered and reviewed study data.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Organized, analyzed and modeled study data.
- Kept patient care protocols and clinical trial operations in compliance.
- Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
- Provided training to study staff on protocol requirements and GCP regulations.
- Placed orders for medications to be used in studies.
- Reviewed CRFs for completeness and accuracy before database entry.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Coordinated investigator meetings, conference calls, and site initiation visits as needed.
Clinical staff
Alexander Medical Spa
10.2019 - 12.2019
Clinical staff
Opa-Locka Medical Clinic
03.2017 - 09.2019
Licensed Physician, Vascular Technologist, Research in vascular Diseases
CDR
Barranquilla, Colombia
01.2012 - 01.2015
Licensed Physician, Research in Vascular Diseases
Clínica de La Costa
Barranquilla, Colombia
01.2011 - 01.2012
Licensed Physician
Clínica General Del Norte
Barranquilla, Colombia
01.2007 - 01.2011
Licensed Physician
Ecocaribe
Barranquilla, Colombia
01.2005 - 01.2007
General Practitioner
ESE Hospital San José
Fusagasuga
01.2003 - 01.2004
Social Services Emergency Doctor
Clínica de La Costa
Barranquilla, Colombia
01.2002 - 01.2003
Social Services Licensed Physician
Estación de guardacostas
Turbo, Colombia
01.2000 - 01.2001
Research Coordinator II
Cleveland Clinic Florida Hematology-Oncology
04.2023
Education
Registered Nurse - Associate of Science in Nursing
Antigua College International
01.2023
Post-Graduate training - Non-Invasive Vascular Diagnostic Studies
Colombia
01.2008
Post-Graduate training - Lymphoedema Treatment
Argentina
01.2006
Doctor of Medicine -
Universidad del Norte
01.1999
Clinical Internship -
Hospital San José
01.1998
Skills
- Microsoft Office (Word, Excel, Power Point, Microsoft outlook)
- Clinical Conductor CTMS
- Real Time CTMS
- Vial CTMS
- MCT CTMS
- IRT/IWRS/IVRS Endpoint, Clinphone,4G, Signant Health)
- EDC (iMedidata, RedCap,Inform,Clincapture etc)`
- Electronic Medical Records (Athena, EMA, EPIC)
- RESEARCH
- Coordinated phase II, III, and IV clinical trials
- Communicated with IRBs, Pharmaceutical companies and CROs to assure regulatory requirements are followed according to research protocols, GCP’s and FDA’s guidelines
- Processed and maintained regulatory documents for each trial
- Trained new study coordinators and research assistants
- Generated source documents for different trials
- Maintained CRFs, and source documents Ensured the prompt solution of queries
- Familiar with Electronic data capturing
- Assessed patients for safety and efficacy of study medications
- Ensured the timely report of SAEs
- Performed assessment of patients including lab procedures and ECGs
- Dispensed medications and maintained drug accountability logs
- Coordinated patient screening and enrollment through telephone interviews
- Conduct Pre-site qualification visits, Site initiation visits, Monitoring visits and close out visits
- FDA Audits
- Investigator meeting
- Phlebotomy /blood collection and preparation for specific test/ urine and other specimen samples/Administer injections and other investigational products
- Perform routine laboratory and study specific test and sample analysis/Explain treatment procedures and medication to the patients or subjects
- Record medical history, information and vital statistics in medical review medical records and laboratories results
- EKG and other medical equipment
Certification
Registered Nurse, RN9643102, 10/02/2023, 4/30/2025
Accomplishments
- RN - Antigua College International
- M.D. - University Del Norte
- R.V.T - Colombian Vascular Surgery and Angiology Association
Experience As Speaker
- IV Symposium of practical applications in Vascular Diseases - Barranquilla Colombia February 2007- Speaker
- V Symposium of the Colombian Angiology and Vascular surgery Association -Barranquilla Colombia March 2008-Speaker
- VI Symposium of the Colombian Angiology and Vascular surgery Association -Barranquilla Colombia March 2009-Speaker
- III Workshop of ulcers and Lymphoedema Barranquilla - Colombia March 2010- Speaker
Certifications Courses
- Clinical Research Coordinator course (CITI Program)
- CITI Health information Privacy and Security (hips) for Research Coordinators
- GCP For Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
- Good Clinical Practice (FDA Focus)
- Transporting Dangerous Goods
- IATA
- HemoCue Certification
- Registered Medical Assistant -RMA
- Registered Phlebotomy Technician (HPRUS)
- Registered EKG Technician (HPRUS)
- OSHA Certification
- HIPAA certification
- Medidata Certified Clinical Research Coordinator
- CPR and BLS certification
Registered Vascular Technologist
MD, Colombia, Perform and interpretation of non-invasive studies and treatment of Lymphatic diseases, Peripheral Arterial and Venous Doppler Ultrasound, Abdominal arterial and venous doppler ultrasound, Carotids and Vertebral arteries Doppler Ultrasound, Renal Doppler Ultrasound, Plethysmography, Management of patients with Lymphoedema- integral management with manual lymphatic drainage, compression therapy, pressotherapy machine.
Research
- NEPHROLOGY TRIALS:
- GSK 200807- A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin, following a switch from erythropoietin-stimulating agents.
- GlaxoSmithKline GSK 200808- A Phase 3 randomized, open-label, active-controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of GSK1278863 compared to darbepoetin alfa.
- GlaxoSmithKline GSK 205270. A 28-Week, randomized, double-blind, placebo-controlled, parallel-group, multi-center, study in recombinant human erythropoietin (rhEPO) naïve non-dialysis participants with anemia associated with chronic kidney disease to evaluate the efficacy, safety, and effects on quality of life of daprodustat compared to placebo.
- Gilead Sciences Inc - GS-US-223-1017- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Selonsertib in Subjects with Moderate to Advanced Diabetic Kidney Disease
- Tricida Inc -TRCA303 - A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis
- Reata Cardinal- 402-C-1603. A phase 2/3 trial of the efficacy and safety of bardoxolone methyl in patients with Alport Syndrome.
- Reata Eagle-402-C-1803 An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease
- AstraZeneca – SAPPHIRE D5495C00002 A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients with Chronic Kidney Disease and Hyperuricemia
- MegaPro Biomedical Company, LTD IOP-CT-004 “A 2-Part, Open-Label, Phase II Study of Intravenous, Single Ascending Dose Administrations of IOP Injection in Patients With Iron-Deficient Anemia”
- Ardelyx, Inc. TEN-02-401: A Long Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination with Sevelamer to Treat to Goal Serum Phosphorus in patients with End-Stage Renal Disease on Dialysis (NORMALIZE)
- Ardelyx, Inc. TEN-02-402: Randomized Open Label Study to Evaluate the use of Tenapanor as the core therapy in the treatment of Hyperphosphatemia in patients with chronic kidney disease on Dialysis (NORMALIZE)
- AstraZeneca PROVENT-D8850C00002 Study Phase III Randomized study, double blind, Placebo controlled, Multi-center Study in adults to Determine safety and Efficacy of AZD7442, a combination of two monoclonal antibodies (AZD8895 and AZD1061) for pre-exposure Prophylaxis of COVID-19
- Vertex Pharmaceuticals Incorporated - VX19-NEN-801, A Study of the Prevalence of Apolipoprotein L1(APOL1) Alleles Among Individuals with Proteinuric Kidney Disease Who Are of Recent African Ancestry or Geographic Origin (Pro00040455)
- DERMATOLOGY TRIALS:
- Galderma Arcadia Protocol RD.06.SPR.118161 A Randomized Double blind, Placebo Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects with Moderate to-Severe Atopic Dermatitis
- Galderma Arcadia LTE Protocol RD.06.SPR.118163 – Rollover study - A Randomized Double blind, Placebo Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects with Moderate to-Severe Atopic Dermatitis
- UCB- Biopharma PS0015 -A Multicenter, Randomized, Double blind, Secukinumab-Controlled, Parallel Group Study to evaluate the Efficacy and Safety of Bimekizumab in Adults Subjects with Moderate to severe Psoriasis
- Castle Biosciences- Prospective Development and Validation of a Gene Expression Assay to predict the risk of recurrence Disease in Cutaneous Squamous Cell Carcinoma
- Corrona Psoriasis (PSO) Registry, Non- Interventional Psoriasis Registry Study.
- Mindera Corporation -An Exploratory Multicenter, Observational Study to examine RNA biomarkers of psoriasis subjects through the application of the Mindera Kit Part 2 (STAMP-2)
- Amgen Inc, A multicenter, Randomized, Double blinded Study, evaluating the Pharmacokinetics, Efficacy, and safety of Multiple Switches between Ustekinumab in Subjects with Moderate to Severe Plaque Psoriasis
- Novartis CLOUA0642302 -A multicenter randomized, double blind, placebo-controlled Phase 3 Study with Remibrutinib (LOU064) to investigate the efficacy, Safety, and tolerability for 52 weeks in adult chronic spontaneous urticaria in patients inadequately controlled by H1- Antihistamines
- UCB Biopharma SRL- Protocol HS0004 A phase 3, Randomized, Double-Blind, placebo-controlled, Multicenter study, evaluating the efficacy, Safety, and tolerability of Bimekizumab in Study participants with Moderate to Severe Hidradenitis Suppurativa
- Galderma Olympia A prospective, Multicenter, Long-term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis
- Galderma Olympia LTE – rollover study A prospective, Multicenter, Long-term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis
- UCB Biopharma Protocol PS007-Multicenter, Randomized, Parallel group. Double-Blind Placebo-controlled (12-17 years) Including a single Open Label Arm(6-11yrs) Study to evaluate the efficacy of Certolizumab Pegol in Pediatric participants.
- Janssen CNTO1959PSO3018- A Phase 3b Multicenter, Randomized, Double blind, Placebo controlled Study evaluating the Safety and Efficacy of Guselkumab for the Treatment of participants with Skin color who have Moderate to-Severe Plaque Psoriasis and/or Moderate-to-Severe Scalp Psoriasis
- Alumis ESK-001-006- a Randomized, Double blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ESK-001 in patients with Moderate to Severe Plaque Psoriasis
- ONCOLOGY TRIALS:
- Genie-B – Genetic and Inflammatory Biomarkers in Neuropathic Pain Secondary to chemotherapy- A study in patients undergoing treatment for Breast Cancer
- Art and Music- A Randomized controlled trial to assess the benefit of Art and Music Therapy in quality of life in patients with Breast Cancer.
- NSU Biomarkers- Clinical evaluation of NSE and S100B as Biomarkers for chemotherapy induced peripheral neuropathy. CIPN
- Janssen MMY3021-A randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance treatment in patients with newly diagnosed Multiple Myeloma who are minimal Residual Disease positive after frontline Autologous Stem Cell Transplant.
- CAEL 101-301 CAELUM Cardiac amyloid reaching for extended survival -A phase 3 Double blind, multicenter study to evaluate the efficacy and safety of CAEL-101 and plasma cell dyscrasia treatment vs placebo and plasma cell dyscrasia treatment naïve patients with Mayo stage IIIB AL Amyloidosis
- CAEL302CAELUM Cardiac amyloid reaching for extended survival -A phase 3 Double blind, multicenter study to evaluate the efficacy and safety of CAEL-101 and plasma cell dyscrasia treatment vs placebo and plasma cell dyscrasia treatment naïve patients with Mayo stage IIIA AL Amyloidosis
- MA39 Tailor RT A randomized trial of regional radiotherapy in Biomarker low risk Node positive Breast Cancer
- EAA173-Daratumumab to enhance therapeutic effectiveness of Revlimid in Smoldering Myeloma
- BMS-IM048-022 A Phase 3, Two stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide maintenance to Lenalidomide maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in participants with newly Diagnosed Multiple Myeloma (NDMM)
- CARIS-The CARIS Biorepository Research Protocol-Blood collection.
Languages
- English
- Spanish
Hobbies and Interests
- Music
- Travelling
- Photography
Timeline
Research Coordinator II
Cleveland Clinic Florida Hematology-Oncology
04.2023
Senior Clinical Research Coordinator II
Riverchase Dermatology and Cosmetic Surgery
09.2021 - 09.2023
Clinical Research Coordinator I
South Florida Research Institute
01.2020 - 09.2021
Clinical staff
Alexander Medical Spa
10.2019 - 12.2019
Clinical staff
Opa-Locka Medical Clinic
03.2017 - 09.2019
Licensed Physician, Vascular Technologist, Research in vascular Diseases
CDR
01.2012 - 01.2015
Licensed Physician, Research in Vascular Diseases
Clínica de La Costa
01.2011 - 01.2012
Licensed Physician
Clínica General Del Norte
01.2007 - 01.2011
Licensed Physician
Ecocaribe
01.2005 - 01.2007
General Practitioner
ESE Hospital San José
01.2003 - 01.2004
Social Services Emergency Doctor
Clínica de La Costa
01.2002 - 01.2003
Social Services Licensed Physician
Estación de guardacostas
01.2000 - 01.2001
Registered Nurse - Associate of Science in Nursing
Antigua College International
Post-Graduate training - Non-Invasive Vascular Diagnostic Studies
Colombia
Post-Graduate training - Lymphoedema Treatment
Argentina
Doctor of Medicine -
Universidad del Norte
Clinical Internship -
Hospital San José
Registered Nurse, RN9643102, 10/02/2023, 4/30/2025
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