Director of Clinical Operations
Marice Arcia
FMD, RN, Senior CRC
Invictus Clinical Research Group
Research experience
A phase III study to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in adults.
A Phase III Randomized, Double-Blind, Placebo- controlled, Multicenter study to determine the safety and efficacy of AZDxxx for the treatment of COVID-19 in non-hospitalized adults (Tackle) 2021 ongoing.
A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZDxxxx, a Combination Product of Two Monoclonal Antibodies (AZDxxxx and AZDxxxx), for Pre-exposure Prophylaxis of COVID-19– PROVENT -2020-ongoing.
ASTRA ZENECA
2020 – 2021
A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZDxxxx, a Combination Product of Two Monoclonal Antibodies (AZDxxxx and AZDxxxx), for Post -exposure Prophylaxis of COVID-19– STORM CHASER- 2020 ongoing
Others studies
- Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to
- Evaluate the Dose-Response Relationship of the Efficacy and Safety of Two Concentrations of
- XXX cream, in Subjects with Actinic Keratosis (AK) of the Face and/or Scalp. Over a 12-week Treatment Period.
- A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy, and Safety Study of XXX Ointment in Adult Subjects with Actinic Keratosis on the Face or Scalp.
- A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of XXX for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris.
- A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of XXX Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea.
- An Open-Label Study to Evaluate the Long-Term Safety of Topical Administration of XXX for 40 weeks in the Treatment of Moderate to Severe Facial Papulopustular Rosacea.
- A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety and Efficacy of XXX in Patients with Type 2 Diabetes with Albuminuria Treated with Renin-Angiotensin System Inhibitors.
- A Phase 3, multi-center, multi-national, placebo-controlled, randomized,
- Double-blind 26-week study to assess the safety and efficacy of XXX in patients with severe hypertriglyceridemia.
- A randomized, parallel-group, double-blind and open-label, placebo-controlled, multicenter study to assess the efficacy and safety of XXX in subjects with uterine fibroids
- A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of XXX and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis.
- A Phase 3b Study to Evaluate the Long-Term Safety and Efficacy of XXX in Combination with XXX for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women
- A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Bexagliflozin Tablets as Monotherapy on HbA1c in Subjects with Type 2 Diabetes Mellitus
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Long-Term Safety and Tolerability Study Of ETC-1002 in Patients with Hyperlipidemia at High Vascular Risk who are not Adequately Controlled By Their Lipid-Modifying Therapy.
- A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
- Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability, and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris
- A 10-week double-blind parallel group to evaluate the efficacy of one daily dose of XXX (300 mg) qd to twice daily dosing of XXX 150 mg BID in subjects with essential hypertension.
- A 26-week open-label active comparator three-armed parallel group to evaluate the effect of Liraglutide compared to XXX both in combination with Metformin in subjects with type II Diabetes Mellitus.
PROFESSIONAL EXPERIENCE
Invictus Clinical Research Group
NOV 2020 – Current
Director of Clinical Operations
Impact Health Biometric Testing, Inc
Aug 2020 – MAR 2021
– Responsible to administer the PCR nasal and oral test for COVID-19 detection.
– Responsible to administer the antibody test to determine the presence of COVID-19 antibodies.
ALC Home Health
DEC 2019 – AUG 2020
Responsible for providing critical care to patients such as, tracheostomy care, Gastric tube care, medication administration, wound care, IV management.
Larkin Community Hospital
Per diem
Responsible for providing critical care to patients such as, tracheostomy care, Gastric tube care, medication administration, wound care, IV management.
Sweet Hope Research Specialty Inc.
2015 – 2019
Their primary responsibilities include managing clinical trials and collecting data, informing participants about study objectives and administering questionnaires, Phlebotomy, ECG, GCP guidelines.
CDI, El Manzanillo, Venezuela
2013 – 2014
Work with the primary healthcare team to provide patients with primary medical care services within the standard of care for Internal Medicine patients. Order laboratory and radiology tests and refer patients to specialists when appropriate and called for. Analyze reports, test results, medical records and examinations to diagnose condition of patients and propose treatment options. Prescribe pharmaceuticals, other medications, and treatment regimens to treat identified and documented medical conditions. Discuss potential side effects of medication/treatment with patients and ensure that all allergy information is up-to-date before prescribing medication/treatment. Provide advice to patients for lifestyle and diet changes that may improve their health or help to treat the health issue they are experiencing.
Education
Registered Nurse
mar 2019
State of Florida Department of Health Division of Medical Quality Assurance.
Tallahassee, FL
Associate of Science in Nursing
AUG 2018
International Institute for health care professionals.
Boca Raton, FL
Intensive Care
sep 2013
Aleida Fernandez Hospital.
Havana, Cuba
Medical Degreee – FMD
sep 2007 – jun 2013
University of Havana
Havana, Cuba
Licensure | Certifications
Registered Nurse
mar 2019
State of Florida Department of Health Division of Medical Quality Assurance.
Tallahassee, FL
Medical Asistant
SEP 2014
American Registry of Medical Assistant
Registered Medical Assistant Certification
Westfield, MA
Phlebotomy Technician
sep 2014
American Registry
Phlebotomy Technician Certification
Miami, FL
CPR & ACLS/BLS
MAY 2014
Miami, FL
HOME HEALTH AIDE
MAY 2014
Miami, FL
TRAININGS
- National Institutes of Health (NIH) Training Course “Protecting Human Research Participants”
- Guidance on Good Clinical Practice (GCP) Training
- Mayo Clinic, Mayo Medical Laboratories, Transporting Dangerous Goods, IATA
- CITI, Human Subjects Training Program Rave/iMedidata, Inform, Data Labs.
The Role of Institutional Review Boards (IRBs) in Safeguarding Ethical Research
Introduction: In the realm of research, ensuring ethical standards and protecting the rights and welfare of participants are of paramount importance. This responsibility falls upon Institutional Review Boards (IRBs), which play a vital role in safeguarding ethical...
What are the rights of clinical research participants?
Clinical research participants have several rights that protect their well-being and ensure ethical treatment throughout the research process. These rights are designed to safeguard their autonomy, privacy, safety, and dignity....
What is a clinical trial?
A clinical trial is a research study conducted on human subjects to evaluate the safety, efficacy, and effectiveness of a new medical intervention, such as a drug, medical device, treatment procedure, or preventive measure. Clinical trials are an essential part of the...