1. Summary
A professional offering 6+ years of experience in clinical research coordination. Strong Ability to
practice including but not limited to study procedures, drug assignments, Informed consent, screening
and enrollment procedures, regulatory requirements per sponsor requirements, IRB, AE and SAE’s
submission to sponsor and IRB, specimen processing and shipments, source document creations, CRF,
and ECRF completion and Executes and coordinates daily clinical research activities according to site’s
SOPs, GCP and FDA/ICH Guidelines.
Work Experience
RESEARCH CONCEPTS, GP, LLC
CLINICAL RESEARCH COORDINATOR, HOUSTON, TEXAS — SEP 2015-PRESENT
-Provide clinical trial coordination as specified in IRB approved pharmaceutical studies. -
Report serious adverse events to the IRB and study sponsor including follow-up.
-Ensure accurate, concise and timely completion of case report forms/Data entry, source documents,
AE’s and SAE’ reporting
-Perform pharmacokinetic sampling, blood and urine sampling, specimen processing, PK storage and
shipment of blood samples.
-Screen/phone screen potential patients for multiple clinical trials
-Consenting subjects in pre-admit testing or pre-op holding area -
Consolidating data and data management
-Participate in SIV, phone/web trainings, investigator meetings and monitoring activities.
-Drug accountability
-Completing all study related assessments and determining eligibility
-Communicating with and assisting PI with lab results and research related work
-Assists CRAs and sponsor staff with correspondence, regulatory documents, study updates,
completion of study related logs (enrollment/screening) and query resolution
-Completion of all required training for various protocol
-Pre-operative, Intra-operative, Post-operative Assessments
-Assists Supervisor in training new employees with clinical research ethics, research-related processes
and protocol related procedures
-Venipuncture/Phlebotomy, ECG’s and Vital signs and scheduling study visits with subjects -
Strong attention to detail and obtains all the needed study related documents (electronic medical
records, anesthesia records, hospital medications) for completion of source document and ECRF
completion prior to monitoring visits, ensuring that the data matches with the source and ECRF data
CLINICAL RESEARCH COORDINATOR
SOUTHWEST HOUSTON RESEARCH, HOUSTON, TEXAS — DEC 2006 - MAY 2012
-Assists PI in potential pre-screening, screening and recruitment and ICF process
- Creation of source documents (if not provided by sponsor) using microsoft office or excel based on
protocol requirements
-Venipuncture and obtaining blood/PK/urine samples
-Ensures appropriate specimen collection and processing and shipping as per protocol requirement
and IATA guidelines
Michelle Ann Galenzoga
832-768-2844 michelle.galenzoga@gmail.com 14902 Sugarmist lane, Sugarland, Texas, 77498

2. -Maintains inventory, temperature-maintained, secured storage and replenishment of all study-related
supplies such as lab kits, study-related devices, and study drug
-Assists with the preparation and submissions of sponsor or IRB related documents prior to start-up
and continuation of study
-Exhibits strong compliance with protocol guidelines and requirements of IRB
-Timely submissions of study requirements (enrollment/ICF logs, AE’s, SAE’s and protocol deviations) to
sponsor and IRB
-Communication and correspondence with the sponsor and CRA (scheduling monitoring visits and
query resolution, improvements in study procedures, study issues) -
Attends and participates in Investigator meetings, trainings and web conferences as needed
-Managed multiple protocols, simultaneously at a time (3-5+ studies)
-Participates and assists PI/Sub-I during site initiation visits, monitoring visits and Dialysis Clinics Staff
In-Services
-Ensures source documents are complete, data management/ECRF completion, data is consistent with
protocol requirement and data is entered unto ECRF in a timely manner.
Education
Houston Community College- Associates in Arts Graduate 2015
Future completion of additional 2 years to obtain a Bachelors in Nursing at a University
Skills
Conducting surgical research trials in a hospital, office/clinics and Dialysis clinic setting, knowledge of
iMedidata, Inform, Datalabs and Axiom, high-speed keyboarding skills, knowledge in MS excel, office,
word, powerpoint, creation of Note-to-file, coordinating data from a variety of sources, exceptional
communication, professionalism, customer service skills, knowledge of medical terminology and
processes, phlebotomy/venipuncture, blood sample processing and shipping, operating ECG, CPR
trained, urinalysis, subcutaneous injection. I possess a strong attention to detail, strong organization,
planning and follow-up skills, ability to prioritize, self-directional and very motivated. I am also a
responsible, hard-working, and trustworthy person with professional ethics both in and out of the
workplace and a natural-innate of care and respect towards patients.
Research Experience
* “Evaluation of XXXXX Therapy to Lower Cardiovascular Events.”
* “A Phase III, Open-Label Study of XXXX for Restoration of Function in Dysfunctional Hemodialysis
Catheters.”
* “A Phase III, Randomized, Active-Controlled, Open-Label, Multi-Center Study of the Safety and
Efficacy of XXXX Injection for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously
Treated with Epoetin.”
* “Outcome Trial Evaluating the Efficacy and Safety of XXXX in Adult Patients on Chronic Hemodialysis,
A Randomized Double-Blind, Parallel Group, Placebo Controlled, Multi-Centre Trial.”

3. * “A Randomized, Open-Label, Multicenter, Study of XXX XXX Comparing Two-Extended Dosing
Regimens, Once Every Two Weeks and Once Every Four Weeks, with the Once Weekly Dosing
Regimens for Maintenance Treatment in Anemic Subject with Chronic Kidney Disease.”
* “A Multi-Centered, Two-Arm, Randomized Study Comparing the Effects of XXX-XXX Solution and
Heparin on the Incidence of Catheter Related Blood Stream Infections In Tunneled Chronic Central
Venous Catheters for Dialysis.”
* “A Phase II, Randomized, Double-blind, Placebo-Controlled, Parallel Group, Fixed Dose of Study of
XXXXX in Subjects with Chronic Kidney Disease on Hemodialysis with Hyperphosphatemia.”
* “A Single-Dose, Two-Period, Open-Label, Dose Determination, Randomized, Cross-Over,
Pharmacokinetic Study of XXXXXX Injection and Doxercalciferol (Hectorol) Injection in Subjects with
Stage 5 Chronic Kidney Disease and Secondary Hyperparathyroidism on Hemodialysis.”
“A Multi-center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous
XXXX-XXXX vs. Standard Medical Care in Treating Iron Deficiency Anemia.”
* “The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in
Subjects with Chronic Kidney Disease Stage 5.”
* “An Open-Label, Randomized, Active-Controlled Multi-Center Phase II Dose Finding Study to
Evaluate the Ability of XXX to Lower Serum Phosphate Levels and the Tolerability in Patients with
Chronic Kidney Disease on Maintenance Hemodialysis.”
* “A Randomized, Double-Blind, Placebo-and Sitagliptin-Controlled, Multi-Center Study to Evaluate
safety and Efficacy of XXXXX in Type 2 Diabetes Mellitus Subjects with Moderate and Severe Renal
Impairment Including Subjects on Hemodialysis.”
* “An Open, Randomized, Controlled, Parallel group, Phase III Study to Investigate the Safety and
Efficacy of XXX and Sevelamer Hydrochloride in Hemodialysis.”
* “Study to Evaluate the Improved Management of iPTH with XXXXX-Centered Therapy vs. XXXXX
Therapy with Low-Dose XXXXX in Hemodialysis Patients with Secondary Hyperparathyroidism.”
* “A Double-blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability of
Single Ascending Doses of XXX-XXX in Hemodialysis Subjects with Secondary Hyperparathyroidism.”
* “A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing XXXXXX in Chronic
Kidney Disease Patients Receiving Hemodialysis: The Continuous Replacement Using Iron Soluble
Equivalents Study.”
* “XXXX-XXX Evaluation In Patients with Chronic Kidney Disease and Type 2 Diabetes: The
Occurrence of Renal Events.” A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of a

4. Sublingual sufentanil Tablet 30mcg for the Treatment of Acute Pain in Patients in Emergency Room
Setting.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study Evaluating the
Analgesic Efficacy and Safety of Intravenous CR845 in Patients Undergoing Abdominal Surgery.
Randomised, Double-Blind, Placebo-Controlled Study of ***** (amilsupride for IV Injection) as
treatment of established Post-Operative Nausea and Vomiting, in Patients Who Have had no Prior
Prophylaxis.
Randomised, Double-Blind, Placebo-Controlled Study of ***** (amilsupride for IV injection) as
Treatment of Established Post-Operative Nausea and Vomiting, in Patients Who Have Had Prior
Prophylaxis.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy, and
Safety of ***** Following Abdominoplasty Surgery.