Research Coordinator Clinical

Jean Marie Puorro, BS

* ******** ****** #** ******, New Jersey 07110

**********@*******.*** 224-***-**** (c)

Qualifications Profile

Detail-focused Clinical Research Coordinator committed to quality patient care as well as quality assurance and compliance within clinical settings.

Strong understanding and proficiency in ICH/GCP, FDA, local regulations and clinical trials research processes and systems.

Extensive clinical trial experience in Phase I studies in a variety of therapeutic areas including Oncology and Diabetes.

Ability to efficiently work independently, prioritize, multi-task and meet established deadlines while adhering to sponsor and FDA requirements.

Outstanding communication, listening and leadership skills complimented by commitment to continual personal and peer development.

Education and Credentials

Associate in Applied Science in Nursing, 2008

College of DuPage, Glen Ellyn, IL

Bachelor of Science in Biological Sciences, 2000

Rutgers University, New Brunswick, NJ

Licensure and Certifications:

IV Certification

NIH-Protecting Human Research Participants Certification

CITI-GCP Training Certification

IATA-Packaging and Shipping Infectious Materials Certification

Professional Experience

QUEENS MEDICAL ASSOCIATES, P.C. Fresh Meadows, New York

Clinical Research Coordinator, 02/2017 to 04/2017

Under the supervision of the Director of Clinical Research, was responsible for the successful and accurate progress of clinical trials from the planning stage through trial completion and study closure ensuring protection of research subjects and the integrity of all clinical trials.

Provided assistance to manage subject consenting/screening/enrollment/follow-up/scheduling/study procedures and data management including adverse and serious adverse event reporting and query resolution.

Assisted with routine data verification and quality control, ensuring data integrity and consistently with prescribed study protocol.

Collected, processed, and assisted in the compilation and verification of research data, samples, and/or specimens following strict protocol and detailed instructions.

Served as front liaison with sponsors, Institutional Review Boards and vendors

Demonstrated high proficiency with MS office, Outlook email, electronic case report form platforms and the internet

FRONTAGE CLINICAL SERVICES, Secaucus, New Jersey

Clinical Research Coordinator, 07/2014 to 04/2016

Executed and coordinated daily clinical research activities according to Frontage Clinical Services’ SOPs, GCPs and FDA/ICH guidelines under the supervision of the management team. Interacted with multi-functional study team including: project management team, sponsors, principal investigators, data management, biostatistics, quality assurance, accounting and business development.

Planned, managed and ensured successful execution and completion of routine to complex clinical trials; therapeutic areas included oncology, diabetes, and pain management.

Assisted with preparation of protocols, amendments, informed consents and other necessary documents for review by the sponsors and IRB.

Prepared and submitted regulatory documents to the sponsor and IRB for study approval and continuing review; maintained the Investigator Site File or Regulatory Binder for each study protocol.

Assisted with recruitment efforts, obtained informed consent from potential research subjects, conducted screening procedures and collaborated with the Principal Investigator, Sub-Investigator(s) and other Clinical Research Coordinator(s) to review inclusion/exclusion criteria to verify subject eligibility.

Performed all study related procedures including venipuncture and biological specimen processing; obtained vital signs and ECG recordings and performed safety assessments as indicated by the study protocols.

Ensured safety of study participants by working with the Principal Investigator and Sub-Investigator(s) on adverse event case processing, reporting and follow-up; alerted the Principal Investigator, Sub-Investigator(s), sponsor and IRB of serious adverse events within 24 hours.

Accurately completed and reviewed all study documentation forms including source documents and case report forms in a timely manner; responded to and resolved data queries in conjunction with the sponsor.

Attended and participated in Pre-Study Site visits, Site Initiation visits, sponsor monitoring visits and sponsor/FDA audits.

CAREPOINT HEALTH-CHRIST HOSPITAL, Jersey City, New Jersey

Staff Nurse-Medical-Oncology Unit, 10/2013 to 07/2014

Rendered professional nursing care to assigned patients in an acute hospital medical/oncology setting by assessing, developing, implementing and evaluating nursing care needs on an individual and continuing basis while adhering to CarePoint Health policies and procedures.

Collaborated with multidisciplinary medical team members on coordination of daily care plans for patients with a wide-array of medical conditions.

Educated patients and family members on disease states and processes, along with all aspects of therapeutic regimens.

Served as patient advocate providing updates and answers to questions expressed by the patient and associated family members, while adhering to HIPPA requirements.

Efficiently and accurately facilitated admissions, transfers, and discharges.

CAREPOINT HEALTH RESEARCH INSTITUTE, Jersey City, New Jersey

Clinical Research Coordinator/RN, 10/2012 to 05/2013

Executed and coordinated daily clinical research activities according to CarePoint Health Research Institute SOPs, GCPs and FDA/ICH guidelines under the supervision of the management team. Managed regulatory documents, prepared study budget proposals and evaluated protocol feasibility at the site.

Built physician/subject contact database for future studies classified by specialty and search criteria.

Obtained informed consent from research subjects, conducted screening procedures and collaborated with Principal Investigator(s), Sub-Investigator(s) and other Clinical Research Coordinator(s) to review inclusion/exclusion criteria to verify subject eligibility.

Prepared and submitted regulatory documents to the sponsor and IRB for study approval and continuing review; maintained the Investigator Site File or Regulatory Binder for each study protocol.

Dispensed study medications and maintained drug accountability logs, drug inventory logs, drug destruction logs and temperature logs for each study protocol.

Performed all study related procedures including venipuncture and biological specimen processing; obtained vital signs and ECG recordings as indicated by the study protocols.

Ensured safety of study participants by working with the Principal Investigator and Sub-Investigator(s) on adverse event case processing, reporting and follow-up; alerted Principal Investigator, Sub-Investigator(s), sponsor and IRB of serious adverse events within 24 hours.

Accurately completed and reviewed all study documentation forms including source documents and case report forms in a timely manner; responded to and resolved data queries in conjunction with the sponsor.

Attended and participated in Investigator meetings, Pre-Study Site visits, Site Initiation visits, sponsor monitoring visits and sponsor/FDA audits.

FRONTAGE CLINICAL RESEARCH CENTER, Hackensack, New Jersey

Clinical Research Nurse, 11/2011 to 11/2012

Interacted and worked under the guidance of the Principal Investigator, Sub-Investigator(s), Director, CRC Clinical Operations Manager, Study Conduct Manager and Clinical Research Coordinators to perform study procedures in compliance with the study protocols.

Maintained a high level of knowledge and understanding of assigned protocols, including all protocol requirements for obtaining written informed consent, subject screening visits, test procedures and subject follow-up visits.

Identified, recruited and screened potential study participants; reviewed and verified subject eligibility based on study inclusion/exclusion criteria.

Monitored subjects and performed nursing assessments during study visits; administered medications and non-medical therapies to subjects as ordered by the Principal Investigator.

Performed venipunctures for screening visit safety assessments and pharmacokinetic samples, and obtained IV access, vital signs, and ECG recordings as required by the study protocols.

Ensured safety of study participants by working with the Clinical Research Coordinator(s) and Principal Investigator on adverse event case processing, including call handling, reporting and follow-up; alerted Principal Investigator of serious adverse events.

Accurately completed and reviewed all study documentation forms including source documents and case report forms.

HACKENSACK UNIVERSITY MEDICAL CENTER, Hackensack, New Jersey

Staff Nurse – Medical / Surgical Unit, 11/2008 to 12/2009

Performed as RN on 33-bed medical-surgical floor and provided nursing care to non-critically ill patients with a wide array of medical conditions. Worked closely with physicians, surgeons, technicians, and therapy staff members on synchronizing patient care. Conducted in-depth assessments, communicated findings to physicians, and coordinated tests and treatments with ancillary departments. Administered medications, obtained IV access, managed peripheral and central IV lines, performed urethral catheterizations, provided wound care, and managed tube feedings.

CENTRAL DUPAGE HOSPITAL, Winfield, Illinois

Patient Care Technician – Medical-Oncology Unit, 09/2006 to 08/2007

Supported nursing staff with various aspects of general patient care, including collecting specimens, performing and transmitting EKG’s, and executing blood glucose testing. Accurately and efficiently documented patient ADLs, vital signs, weights, I&O, and calorie counts. Observed patients and reported any noticeable change in behaviors or condition to nursing team.

Instrumental in increasing patient satisfaction scores to 96% within the unit throughout improved hourly rounds.

Ensured safety of assigned patients by consistently following internal and external governing policies and procedures.

ABBOTT LABORATORIES, Abbott Park, Illinois

CAPA Specialist - Environmental Monitoring Organization, 06/2003 to 07/2005

Served as Corrective and Preventative Action (CAPA) expert for the Bio-Analytical Quality Assurance (BAQA) Environmental Monitoring organization. Conducted on-site investigations of manufacturing areas exhibiting environmental excursions and resolved associated issues with respective areas through the CAPA system. Authored, implemented, and completed non-conformance reports, corrective actions, corrections, deviation reports and risk assessments.

Ensured compliance with site-level policies and practices by implementing and monitoring quality programs.

Served as team mentor and shared in-depth quality assurance experience and scientific knowledge with all levels of staff.

ABBOTT LABORATORIES, Abbott Park, Illinois

Advanced Quality Technician – BAQA Microbiology, 06/2001 to 06/2003

Properly prepared, performed and documented a wide-array of microbial testing including Micro Membrane Filtration, Streak Plate, and Sterility testing on in-process and final product materials with strict adherence to GMP/GDP according to FDA regulations.

Drove continuous compliance within quality unit by developing and installing internal process improvements.

Reviewed and updated SOPs.

Research Experience

2015-2016 Clinical Research Coordinator- A Phase 1, Open-Label, Sequential, Multiple-Dose, Drug-Drug Interaction Study of GK Activator HMS5552 and Metformin in Patients with Type 2 Diabetes Mellitus (T2DM). Sponsored by Hua Medicine (Shanghai) Ltd.

Clinical Research Coordinator- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Four Once-Weekly Subcutaneous Doses of PB-119 to Subjects with Type 2 Diabetes Mellitus (T2DM). Sponsored by PegBio Co., Ltd.

Clinical Research Coordinator- A Phase 1,Open-Label, Single Center, Parallel Group Study of the Effect of Rociletinib on the Pharmacokinetics of Omeprazole and Digoxin and the Effect of Paroxetine or Omeprazole on the Pharmacokinetics of Rociletinib in Healthy Adult Subjects. Sponsored by Clovis Oncology, Inc.

2014 Clinical Research Coordinator- A Phase 1, Randomized, Open-Label, Single Dose, Crossover Study of the Effect of Food on the Pharmacokinetics of Rociletinib in Healthy Adult Subjects. Sponsored by Clovis Oncology, Inc

Clinical Research Coordinator- A Phase 1,Open-Label, Single Center, Parallel Group Study of the Effect of Rociletinib on the Pharmacokinetics of Omeprazole and Digoxin and the Effect of Paroxetine or Omeprazole on the Pharmacokinetics of Rociletinib in Healthy Adult Subjects. Sponsored by Clovis Oncology, Inc.

2013 Clinical Research Coordinator- A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib, and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma. Sponsored by Celgene Corporation.

Clinical Research Coordinator- A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma. Sponsored by EMD Serono, Inc.

Clinical Research Coordinator- Multi-Center, Randomized, Evaluator-Blind, Active Controlled, Parallel-Group Design to Determine Safety, Tolerability, and Efficacy of Multiple Daily Administration of LFF571 for 10 Days in Patients With Moderate Clostridium Difficile Infections. Sponsored by Novartis.

Clinical Research Coordinator- A Phase 3, Randomized, Double-Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12cm2 to < 36 cm2. Sponsored by Healthpoint.

2012 Clinical Research Nurse- Protocol BAY98-7111: A Bioavailability Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Under Fasting Conditions and Naproxen Sodium/Diphenhydramine Hydrochloride Combination Product Under Fasting and Fed Conditions. Sponsored by Bayer Healthcare.

Clinical Research Nurse- Protocol YPC 2012-001: A Randomized, Open-Label, Single Dose, Two-Period, Crossover Study to Assess the Bioequivalence of Reference and Test Formulations of Efavirenz 600 mg Tablet Administered Under Fasted Conditions in Healthy Male and Female Subjects. Sponsored by Yabao Pharmaceutical Co., Ltd.

Clinical Research Nurse- Protocol LY03003/CT-1S01: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03003 following Escalating Single Intramuscular Injection. Sponsored by Shandong Luye Pharmaceutical Co., Ltd.

2012 Clinical Research Nurse- Protocol HS-25-I: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of HS-25 Following Escalating Single Oral Administration. Sponsored by Zhejiang Hisun Pharmaceutical Co., Ltd.

Clinical Research Nurse- Protocol ABS-101: A Phase 1, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Determine the Safety, Tolerability and Pharmacokinetics of Piroxicam Following Single and Repeated Doses of a Topical Piroxicam Patch (AB001) and the Bioavailability of the Piroxicam Patch Relative to the Oral Piroxicam Capsule in Healthy Subjects.

Clinical Research Nurse- Protocol ZHU 2012-004: A Randomized, Open-Label, Single-Dose, Two-Period, Crossover Study to Assess the Bioequivalence of Reference and Test Formulations of Amoxicillin 500 mg Capsule Administered Under Fed Conditions in Healthy Male and female Subjects. Sponsored by Zhuhai United Laboratories (Zhongshan) Co., Ltd.

Clinical Research Nurse- Protocol RP-OX-PK002: A Pilot, Randomized, Open-Label, Two-Period, Crossover, Single Dose Relative Bioavailability Study of Oxycodone Hydrochloride Immediate-Release Tablets and Roxicodone in Healthy Adults under Fed Conditions. Sponsored by Rhodes Pharmaceuticals L.P.

2011 Clinical Research Nurse- Protocol TEV-2011-001: A Randomized, Open-Label, Single-Dose, Two-Period, Crossover Study to Assess the Bioequivalence of Reference and Test Formulations of Lamivudine/Zidovudine 150/300 mg Tablets Administered Under Fasted Conditions in Healthy Male and Female Subjects. Sponsored by TEVA Pharmaceuticals.

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