Experienced Study Coordinator with background managing multiple research studies in diverse scientific disciplines. Proven skills in study protocols, data collection, and participant recruitment. Strengths include effective communication, organization, and ability to meet project deadlines consistently. Previous work has demonstrated significant improvement in study efficiency and participant retention rates.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Study Coordinator
Clinical Research Puerto Rico
San Juan
01.2024 - Current
Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
Conducted screening interviews to determine eligibility of possible subjects.
Kept patient care protocols and clinical trial operations in compliance.
Served as primary contact between sponsor companies and investigators throughout each stage of the trial process.
Assisted in preparation of submissions for Institutional Review Board approval process.
Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Maintained close communication with project teams including investigators, CRAs, vendors and external partners regarding study milestones and timelines.
Participated in feasibility assessments at potential investigative sites in order to determine suitability for participation in a given study.
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Clinical Research Coordinator / Regulatory Official
Mindful Medical Research
San Juan
01.2022 - Current
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 .
Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
Coordinated investigator meetings, conference calls, and site initiation visits as needed.
Conducted screening interviews to determine eligibility of possible subjects.
Collected, processed and delivered specimens from trial participants.
Took vital signs and collected medical histories as part of study protocols.
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
Educated participants on studies and anticipated outcomes.
Case Investigator
Carolina Township
Carolina
01.2020 - Current
Created process to capture, integrate, and maintain data supporting field information applications.
Completed data entry to facilitate case interview and elicited close contacts into designated system immediately after obtaining.
Assisted individuals with navigating health care systems, appointments and classes.
Assessed the needs of those exposed to COVID-19 and connected them with appropriate resources.
Collaborated with public health officials and healthcare providers to ensure accurate information was shared regarding COVID-19 cases.
Maintained confidential records of contact tracing activities in accordance with HIPAA regulations.
Followed set protocol for contacting assigned newly diagnosed COVID-19 case patients and documented contact attempts and timeframes.
Education
Master's Degree -
NUC University
Rio Grande, PR
05.2025
Bachelor's degree - nursing
University of Puerto Rico
Mayaguez, PR
01.2019
Skills
Clinical research
Data management
Protocol adherence
Regulatory compliance
Effective communication
Project management
Patient education
Good clinical practices
IRB submissions
Patient care coordination
Certification
Register Nurse License-96079
Seminars Courses
Protecting Human Research Participants Online Training (PHRP), 01/01/24
Training for Responsibilities of Shippers/Cargo Agents for Transport of Dangerous Goods (IATA), 01/01/24
Basic Life Support Program (CPR & AED), 01/01/24
NIDA: Good Clinical Practice (GCP), 01/01/24
Research
MK8591B-060: A Phase 2b, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Islatravir (ISL) and Ulonivirine (ULO) Once Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily, 01/01/25
M24-541 A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment, 01/01/24
ESK-001-017 A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2), 01/01/24
M20-465 A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms, 01/01/24
GS-US-563-5925: A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir (B/F/TAF), 01/01/24
209639: Phase 2b Multicenter, Randomized, Open-Label Study comparing the Efficacy, Safety, PK and Tolerability of VH3810109, administered Either Intravenously or As A Subcutaneous Infusion with rHuPH20 in Combination with CabLA to Standard of Care In Virologically Suppressed Adults Living with HIV, 01/01/24
M19-965: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety,Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living with HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption, 01/01/24
Exhale-4 A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Dexpramipexole Administered Orally for 24 Weeks in Participants With Eosinophilic Asthma, 01/01/24
Exhale-3 A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 52 weeks in participants with severe eosinophilic asthma., 01/01/23
M23-716 A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata, 01/01/23
M23-699: SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE, 01/01/23
M19-44 A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo, 01/01/23
CNTO1959PSA3005- A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants with Active Psoriatic Arthritis who had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Agent, 01/01/22
EHP-101-SS01 A Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients with Diffuse Cutaneous Systemic Sclerosis., 01/01/22
J1V-MC-IMMA- A Master Protocol for a Randomized, Placebo-Controlled Clinical Trial of Multiple Interventions for the Treatment of Systemic Lupus Erythematosus (Pro00059195)., 01/01/22
I5T-MC-AACM- A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease (Pro00054759)., 01/01/22
M20-466- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs), 01/01/22
M20-186- A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or Combination (ABBV-599) in Subjects with Moderate to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT), 01/01/22
M19-130- A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus, 01/01/22
I4V-MC-JAJA- A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis, 01/01/22
J1P-MC-KFAJ A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of LY3471851 (NKTR 358) in Adults with Systemic Lupus Erythematosus ISLAND-SLE, 01/01/22
M16-011-A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1), 01/01/22
Languages
Spanish
First Language
English
Intermediate (B1)
B1
References
References available upon request.
Timeline
Study Coordinator
Clinical Research Puerto Rico
01.2024 - Current
Clinical Research Coordinator / Regulatory Official
Urban Planning & Research Specialist at Puerto Rico Science, Technology & Research TrustUrban Planning & Research Specialist at Puerto Rico Science, Technology & Research Trust
Coordinator at Office of Epidemiology and Research, Puerto Rico Department of HealthCoordinator at Office of Epidemiology and Research, Puerto Rico Department of Health