Clinical Research Coordinator
Resume:
JESUS GUTIERREZ
*****.***********@*****.***
Education & Certification:
● Bachelor of Science -- Biology - Cal State Long Beach 2018
● Certified Phlebotomy Technician - U.S. Colleges of Health and Sciences 2018
● Associates Degree - Santa Ana Community College 2016
● CA Technician 1 License 2018-current
● National Phlebotomy Technician 1 2018-current
● IATA 2019-current
● Good Clinical Practice (GCP) 2019-current
Experience
Folio Clinical Research, Murrieta Dr. Madhumitha Reddy M.D. Lead Clinical Research Coordinator September 2024
● Conduct subject visits of multiple phase II-IV for urology and oncology
● Manage drug accountability by balancing both incoming medication and medication being dispensed to subjects.
● Assisting with the creation of paper source via the eCRF guidelines and reading through the protocol
● Assisting with monitoring visits and making sure that all queries are answered and completed.
● Manage kit inventory and order more kits as needed for the subject’s blood draws.
● Lab processing lab specimens that were drawn for the day
● Shipping lab specimens via Fedex or UPS to LabCorp, Covance, Q2 Solutions, etc
● Support in outreach events in informing the community on clinical research Syrentis Clinical Research, Santa Ana Dr. John Duffy M.D. Clinical Research Coordinator June 2022- August 2024
● Conduct subject visits of multiple phase III-IV clinical trials for COPD, Alzeheimers, and Psoriasis.
● Manage drug accountability by balancing both incoming medication and medication being dispensed to subjects.
● Assisting with the creation of paper source via the eCRF guidelines and reading through the protocol
● Assisting with monitoring visits and making sure that all queries are answered and completed.
● Manage kit inventory and order more kits as needed for the subject’s blood draws.
● Lab processing lab specimens that were drawn for the day
● Shipping lab specimens via Fedex or UPS to LabCorp, Covance, Q2 Solutions, etc
● Support in outreach events in informing the community on clinical research First OC Dermatology Clinic, Fountain Valley Dr. Vivian Laquer M.D. Clinical Research Coordinator April 2019 – June 2022
● Conduct subject visits of multiple phase III-IV clinical trials for psoriasis, atopic dermatitis, acne vulgaris, psoriatic arthritis, vitiligo, hidradenitis suppurativa, etc
● Manage drug accountability by balancing both incoming medication and medication being dispensed to subjects.
● Assisting with the creation of paper source via the eCRF guidelines and reading through the protocol
● Assisting with monitoring visits and making sure that all queries are answered and completed.
● Manage kit inventory and order more kits as needed for the subject’s blood draws.
● Lab processing lab specimens that were drawn for the day
● Shipping lab specimens via Fedex or UPS to LabCorp, Covance, Q2 Solutions, etc Additional Information
● Computer skills: Windows, Mac OS X, Microsoft (Word, Excel, Powerpoint)
● Languages: English, Spanish
First OC Dermatology
● Clinical Research Coordinator for M16-005- A Multicenter, Single-Arm, Open-Label Study to Assess the Usability of the Risankizumab Autoinjector Combination Product in Adult Patients with Moderate to Severe Plaque Psoriasis
● Clinical Research Coordinator for M16-046 - A Phase 3b Multicenter, Randomized, Double- Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis
● Clinical Research Coordinator for M19-850 - A Phase 3b, open-label treatment extension study of upadacitinib for the treatment of adult subjects with moderate to severe atopic dermatitis who completed treatment in Study M16-046
● Clinical Research Coordinator for M19-977- A Randomized, Active-controlled, Efficacy Assessor-blinded Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
● Clinical Research Coordinator for M19-973- A Phase 3 Multicenter, Single-arm, Open- label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977
● Clinical Research Coordinator for ASLAN004-003 - A Randomized, Double-Blind, Placebo Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Adult Patients with Moderate-to-Severe Atopic Dermatitis
● Clinical Research Coordinator for AUR101-202 - A Phase II, Multicenter, Double blind, Double-dummy, Placebo controlled, Randomized Study to Evaluate the Efficacy and Safety of AUR101 in patients with Moderate-to-Severe Psoriasis
● Clinical Research Coordinator for Amgen 20190232- A Phase 3, Multicenter, Randomized, Double-Blind Study Evaluating the Efficacy and Safety of ABP 654 Compared with Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
● Clinical Research Coordinator for Amgen 20190194- A Randomized, Double-Blind, Placebo- Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria
● Clinical Research Coordinator for DRM06-AD07/J2T-DM-KGAA- A Long-Term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis
● Clinical Research Coordinator for KPL-716-C201- A Phase 2a/b, Randomized, Double- Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects with Prurigo Nodularis
● Clinical Research Coordinator for HS0004- A Phase 3, Randomized, Double-blind, Placebo- Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants with Moderate to Severe Hidradenitis Suppurativa
● Clinical Research Coordinator for HS0005- A Phase 3, open-label, parallel group, multicenter, extension study evaluating the long-term treatment of bimekizumab in study participants with moderate to severe hidradenitis suppurativa
● Clinical Research Coordinator for TILD-19-07- A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Experienced Subjects with Active Psoriatic Arthritis I
● Clinical Research Coordinator for TILD-18-19- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis
● Clinical Research Coordinator for TILD-18-20- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Plaque Psoriasis of the Scalp
● Clinical Research Coordinator for C3291035- A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction with Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) with Mild-to-Moderate Atopic Dermatitis, who Responded to Twice Daily Crisaborole Ointment, 2%,Treatment
● Clinical Research Coordinator for LP0162-1337- An open-label, single-arm, multi-center, long- term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab clinical trials
● Clinical Research Coordinator for B7931022- A Phase 2b, multicenter, randomized, double- blind, vehicle controlled, parallel group dose ranging study to assess efficacy, safety, tolerability and pharmacokinetics of PF-06700841 cream in participants with mild or moderate atopic dermatitis
● Clinical Research Coordinator for B7931023- A Phase 2B Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants with Chronic Plaque Psoriasis
● Clinical Research Coordinator for I6T-MC-AMAH- A Multicenter, Long-Term Extension to Evaluate the Long-Term Safety and Maintenance of Treatment Effect of Mirikizumab in Patients with Moderate-to-Severe Plaque Psoriasis
● Clinical Research Coordinator for I7P-MC-DSAD- A Multicenter, Randomized, Double- Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3041658 in Adults with Moderate-to-Severe Hidradenitis Suppurativa
● Clinical Research Coordinator for J1B-MC-FRCC(e)- Phase 1, Multicenter, Randomized, Placebo-Controlled, Triple-Blind, Single-Ascending Dose and Repeat-Dose Trial in Healthy Participants and Participants with Atopic Dermatitis
● Clinical Research Coordinator for I4V-MC-JAIX- A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Moderate to Severe Atopic Dermatitis
● Clinical Research Coordinator for I1F-MC-RHCR- A 24-Week Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients with Moderate-to-Severe Plaque Psoriasis
● Clinical Research Coordinator for CAIN457P12302- A Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks with Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects with Active Psoriatic Arthritis
● Clinical Research Coordinator for Pfizer B7451050- A Study to Assess the Safety and Efficacy of Abrocitinib Compared with Dupilumab in Adult Participants with Moderate to Severe Atopic Dermatitis
Syrentis Clinical Research
● Clinical Research Coordinator for NEUP11-7- A Randomized, delayed start, double blind, parallel group, placebo controlled, multicenter study of piromelatine 20 mg in participants with mild dementia due to Alzheimer's disease
● Clinical Research Coordinator for PAD-NY-22-05- A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Padagis Israel Pharmaceuticals, Ltd.’s Roflumilast Cream 0.3% to Arcutis Biotherapeutics, Inc’s Zoryve
(Roflumilast Cream 0.3%) and Both Active Treatments to a Vehicle Control in the Treatment of Plaque Psoriasis
● Clinical Research Coordinator for Chiesi Triton COPD- A phase III, 52-week, multinational, multicenter, randomized, double-blind, 2-arm parallel group study comparing efficacy, safety and tolerability of the fixed dose triple combination of beclomethasone dipropionate plus formoterol fumarate plus glycopyrronium bromide (CHF 5993) with the fixed dose dual combination of beclomethasone dipropionate plus formoterol fumarate (CHF 1535), both administered via pMDI in subjects with chronic obstructive pulmonary disease. Folio Clinical Research
● Clinical Research Coordinator for Debio 4228-201 - A Phase 2, randomized, open-Label, dose-finding study of Debio 4228, an extended-release formulation of gonadotropin-releasing hormone antagonist in participants with locally advanced/metastatic prostate cancer
● Clinical Research Coordinator for CORE-008- A Phase 2, Multi-Arm, Multi-Cohort, Open- Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
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