CURRICULUM VITAE

Gregory A. Babyak, RN, BSN

**** **** ********** ******, **********, PA 15135

Ph: 412-***-****, Cell: 412-***-****

adaxqn@r.postjobfree.com

PROFESSIONAL EXPERIENCE

CLINICAL RESEARCH

Abiomed, Danvers, MA December 2018-May 2019

Senior Clinical Research Associate/Consultant.

Contracted by Real Staffing New York, NY.

Assigned to monitor the east coast region and Canada, of a cardiac device project.

Responsible for reviewing closed, but not locked, data for the purpose of locating, assessing and follow-up of subject AEs and preparing assigned sites for COV.

General on-site monitoring responsibilities;

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review

Monitor data for missing or implausible data.

Oxford Global Resources, Palm Beach Gardens, FL July-October 2018 Senior Clinical Research Associate

Contracted to Cognitive Research Corporation (CRC), St Petersburg, FL

Assigned to monitor CNS / Driving Simulator / Sleep Studies.

Exclusively Canadian assignments.

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, liaise with vendors; and other duties, as assigned

Responsible for all aspects of site management as prescribed in the project plans

General On-Site Monitoring Responsibilities:

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review

Monitor data for missing or implausible data

Ensure the resources of the Sponsor and CRC are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to CRC travel policy

George Clinical US, Tampa Bay, FL June-Oct 2017

Senior Clinical Research Associate.

Assigned to monitor Oncology projects; Metastatic/Advanced RCC, CINV via AC naive Breast Cancer in phase I.

Complex problem solving, site management, site payment application, drive recruitment and enrollment with high success rate for dormant sites.

Ensure compliance with Good Clinical Practices, Regulatory Regulations, SOPs and Protocols.

Prepare accurate and timely trip reports, central network monitoring responsibilities, train new CRAs.

Primary liaison for Site Staff, Vendors and Sponsor.

Timely, executable resolutions to audit.

EDC experience including CTMS, Medidata Rave, including specific attention to conducting Power Point presentations.

Address client needs.

Juno Therapeutics, Seattle, WA. Sep-Oct 2016

Senior Clinical Research Associate

Leukemia projects/autologous bone-marrow acquired stem-cells via laboratory processes.

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned

Responsible for all aspects of site management as prescribed in the project plans

General On-Site Monitoring Responsibilities:

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review

Monitor data for missing or implausible data

Ensure the resources of the Sponsor and Juno are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Juno travel policy

Prepare accurate and timely trip reports

Manage small projects under direction of a Project Manager/Director as assigned

Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned

Review progress of projects and initiate appropriate actions to achieve target objectives

Participate in the development of protocols and Case Report Forms as assigned

Participate in writing clinical trial reports as assigned

Act as contact for clinical trial supplies and other suppliers (vendors) as assigned

Conduct, report and follow-up on Quality Control Visits (CQC) when requested

Quintiles, Cary, NC June-Aug 2016

Senior Clinical Research Associate/Contract through Beaufort, LLC.

Rescue allergy study involving “Risk-Based” data.

Traveling 60-80% as primarily requested for nationwide sites.

Assess for risk-based information required for CTMS confirmation.

EDC experience including CTMS, InForm 5.

Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

Independently perform CRF review; query generation and resolution against established data review guidelines on Quintiles or client data management systems as assigned by management

Assist with training, mentoring and development of new employees, e.g. co-monitoring

Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

Perform other duties as assigned by management

PAREXEL, Waltham, MA Aug-Oct 2015

Senior Clinical Research Associate

Oncology study utilizing bone-marrow and protein isolation/activation vaccine.

Traveled 40-60% conducting monitoring visits; (Site Initiation Visit, Interim Monitoring Visit and Close Out Visit)

Checked drug supplies, site compliance with protocol and all current and ethics submissions and relevant regulations

Conducted source data verification, ensured all serious adverse events (SAEs) were reported appropriately and provided all follow-up requests to sites to correct any issues identified at monitoring visits

Reviewed and provided site progress

Performed source data/CRF verification, regulatory document/Investigator Site File review, drug accountability, queries and submit monitoring reports on time

Conducted ongoing CRF discrepancy resolutions

Monitored SAE reporting by the sites

Assisted Sponsors in finding qualified investigators and patients in finding appropriate clinical trials sponsored by research centers in their locale.

Clinipace Worldwide, Morrisville, NC Feb-July 2015

Senior Clinical Research Associate

Cardiac and oncology device projects, isolating bone-marrow acquired stem cells.

Monitored clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures

Regional Clinical Research Associate II for various Sponsors; Oncology- Phase III Metastatic Sarcoma, Oncology- Phase III Head and Neck Squamous Cell Carcinoma, (Oncology- Phase III Chronic Pain), Endocrinology- Phase II Chronic Kidney Disease, sickle cell, COPD and others

Performed pre-study, initiation, interim monitoring and close out visits as required

Traveled 70% conducting monitoring visits; (Pre-Study Visit, Site Initiation Visit, Interim Monitoring Visit and Close Out Visit)

Replaced CRA for high enrolling sites for Phase II-III clinical studies

Reviewed and provided site progress, performed source data/CRF verification, regulatory document/Investigator Site File review

Primary Liaison for Sponsors, Project Leaders, PI’s, Lead Clinical Research Associates, RN’s and outside vendors; Central Labs, IRB’s and drug shipments/storage facilities

Ensured adequacy of drug shipment, drug accountability, reconciliation counts with CRF, source data, dispensing logs and clinical/lab supplies

Reconciled and returned Investigational products

EDC experience including CTMS, Inform PhaseForward IV, Impact, Recruitment Tracker, Medidata, Clinphone, Oracle RDC, IVRS and electronic subject diaries

Proven leadership skills in team environment, strong verbal, oral and written communication skills, organizational skills, prioritization skills and excellent attention to detail

Previously responsible for subject recruitment and enrollment, reviewed patients’ charts, ensured informed consent proper administration, issued queries/discussed execution issues

Monitored Investigator compliance for reporting of adverse events and serious adverse events

GENO, LLC, Cocoa, FL Aug 2015-Jan 2016

Senior Clinical Research Associate/Contract through ASG, Inc.

Respiratory delivery device study for PAH patients.

DOCs Global, Inc., Raleigh, NC Mar 2011-Mar 2014

Senior/Lead Clinical Research Associate/Contractor

Cardiac Device (AVI-Medtronic) and Oncology Device (ICON rescue study/Hepatic iso.).

Kendle Intl., Cincinnati, OH Mar 2008-Mar 2009

Senior Clinical Research Associate

Oncology, Cardiac, Immunology and endocrine (Nephritis/Proteinuria).

Premier Research Group, PLC, Philadelphia, PA Apr 2007-Mar 2008

Senior Clinical Research Associate

Cardiovascular Device, Urology (UTI/Nephritis), and Ophthalmology in phases II and III.

i3Research, LLC, Cary, NC Mar 2006-Apr 2007

Senior Clinical Research Associate

Oncology, GI, CNS and Endocrine studies in phases II, IIb and III.

Advanced Biologics, New Hope, PA Feb 2004-Mar 2006

Senior Clinical Research Associate

Rheumatology, Pulmonary, CNS, Oncology, Ophthalmology and Immunology in phases II, IIb, III, and IIIb.

ASG, Inc., for TAP Pharm., Vernon Hills, IL Feb 2003-04

Clinical Research Associate/Contract

Oncology, Pulmonary and Cardiac studies in phases II and III.

Integrium, LLC, Orange, CA

Clinical Research Associate Jan 2001-Feb 2003

Cardiac Device, Endocrine Device, GI, Hematology, and Immunology in phases II, IIb, III and IIIb.

PPDI contract/ClinForce, Inc., Morrisville, NC Jan 2000-01

In-House Clinical Research Associate/Contract

CNS, GI and Endocrine in phases II and Iib.

NURSING EXPERIENCE

Bayada Home HealthCare Services, Pittsburgh, PA Oct 2014-Pres

Registered Nurse (part-time)

Maintain established Plan of Care for assigned patients in their homes.

Specifically trained for tracheotomy and ventilator patients.

Since leaving the hospital environment and pursuing clinical research in 2000 I have maintained my nursing license in my state of residence; PA-RN518524L.

Maxim Healthcare Services, Inc, Raleigh, NC/Phila, and Pgh., PA Mar 2000-July 2014

Registered Nurse (part-time)

Specifically trained in tracheotomy and ventilator patients.

Rex Healthcare Inc., Raleigh, NC Aug 1998- Mar 2000

Staff RN, Surgery/ICU/ASU

Maintained the operating theatre and supervised the surgical procedure as a Circulating Nurse or in the capacity of a Scrub Nurse. Orientations in ICU and ASU.

SUMMARY

Eighteen-years as a Regional CRA utilizing a variety of therapies, my most recent project was a Cardiac Hemostasis Device, prior to that was an Oncology (RCC), prior to that was Oncology and another Cardiac Device. Some of these recent studies utilized bone-marrow acquired isolated proteins for oncology and cardiac stem-cells for patients with a recent MI and damaged myocardium. I have a great knowledge and familiarity in ICH/GCP Guidelines. I have nine-year’s experience utilizing EDC and CTMS applications such as TEMPO, DataTrak, SAP, eLinks, SFE, Impact, Medidata Rave, Inform, Oracle and Oasis. My nursing background in surgery and ICU have provided me unique experiences with an expertise of medical language and judgment to assure communication, confidence and rapport with my assigned sites.

EDUCATION

Waynesburg College School of Nursing, Waynesburg, PA Aug 1992-May 1996

Intensive studies of nursing theory for the purposes of creating, fostering and implementing critical thinking with the intentions of patient safety, health, and advocacy.

Acquired BSN.

THERAPEUTIC EXPERIENCE

Cardiovascular:

HTN; 8 studies - 6 phase III, 2 phase IIIb, 4-yrs. TIA; 2 studies (1 rescue study), phase II/IIb, 2-yrs. CVA; 2 studies, phase III/IIIb, 2-yrs. Tamponade; 1 study, phase I/ II, 1-yr. AVI, 1 study, phs III, 1-yr. Pacemaker/Defib, 1 study, phs II, 1-yr. Stent; 1 study, phs IIb, 1-yr. Shunt; 1 study, phs III, 1-yr. Intra-Coronary Infusion; 1 study, phs II, 1-yr. Cardiac Implant/Hemostasis; 1-study, phs III, COV, 1-yr.

Endocrinology:

IDDM; Insulin delivery system, 1 study, phase III, 1-yr. Hypo/Hyperglycemia, 2 studies, phs II/III, 2-yrs. Nephritis (proteinuria); 1 study, phs II, 6-mos. Gout; 5 studies, phs I/II/IIb/III/IIIb, 5-yrs.

Urology:

CUTI; 4 studies, phs I/II/IIb/III, 4-yrs. UTI; 2 studies, phs III/IIIb, 2-yrs. Nephritis (infection); 1 study, phs IIIb, 1-yr.

Immunology;

ID; 3 studies; phase III/IIIb, 3-yrs. Wound care; 2 studies, phase III/IIIb, 1-yr. HIV; 3 studies, phase II/III/IIIb, 2-yrs. Septicemia; 3 studies,1-rescue study, phase III/IIIb, 3-yrs. Hepatitis B/C; 3 studies, phase II/IIb, 3-yrs.

Dermatology;

Eczema/Psoriasis, 2 studies, phs II, 2-yrs.

Ophthalmology/Otology:

Detached Retina; 2 studies, phase II/IIb, 1-yr. Cataract; 1 study, phase IIIb, 1-yr. Eye-dryness; 2 studies, phase III, 2-yrs.

Neurology/CNS:

Bi-Polar Disorder; 2 studies, phase III/IIIb, 2-yrs. Alzheimer’s; 2-studies, phase I/II/IIb, 2-yrs. Epilepsy; 3 studies, phase III/IIIb, 2-yrs. Pain Management; 4 studies, phase III/IIIb, 3-yrs. Parkinson’s; 1 study, phase IIb, 1-yr.

Oncology:

Metastatic/Advanced RCC; 1-study, phase I, 1-yr. CINV via Anthracycline-Cyclophosphamide (AC), 1-study, phase IIIb, 1-yr. Lymphoma; 4 studies, phase I//II/IIb, 4-yrs. Melanoma/Duel-therapy vaccine; 1 study, phase IIb, 1-yr. Melan. /Device using hepa. Isolation; 1 study, phase II, 1-yr. Leukemia (all 4-types); 4 studies, phase II/IIb, 3-yrs. NSCLC; 1 study, phase II, 1-yr. Cutan. Mel. Mets. To Hepatic (liver); 1 study/rescue, phs III, 1-yr. Breast; 1-study, phase II, 1-yr.

Hematology:

Anemia; 1-study, phase II, 1-yr. Blood Dyscrasia; 1-study, phase II, 1-yr.

Gastrointestinal (GI):

GERD; 2 studies, phase III, 1-yr. Diverticulitis; 2 studies, phase III, 2-yrs. Ulcerative Colitis/Crohn’s Disease; 2 studies, phase III, 2-yrs. IBS; 2 studies, phase III, 2-yrs.

Pulmonary:

Asthma; 3 studies, phase III, 2-yrs. COPD; 3 studies, phase III, 3-yrs. Emphysema; 2 studies, phase III, 2-yrs. PAH; Nitric Oxide inhaled DS weaning PGI subjects; 1-study, phs III, 1-yr. Allergy; Rescue Project, 1-study, phs II, 1-yr.

Rheumatology:

Rheumatoid Arthritis; 3 studies, phase I/II/IIb, 2-yrs.

Device:

Cardiology, oncology, endocrinology, ophthalmology; 13 studies.

Visit approximations:

PSSV; 200, SIV; 300, IMV; 2600, COV; 200.

Software

Applications; Impact, Citrix, Windows 95/98, 2000, XP Professional and Widows 7. Microsoft Word, Office, WebEx, Egencia, MasterControl, Excel, RightFax, Orbit Documentation, Novell, PQRS, Crystal Web, Q-Star, QMS, Documetrix, Work Manager, Data Manager. EDC: TEMPO, DataTrak, SAP, eLinks, SFE. CTMS; eCaselink, Medidata Rave, Inform 4.6-5, Field Glass, Turbo Scan, Trial Watch, Trial Web, Oracle, and Oasis.

Professional Affiliations -Pennsylvania Nursing Association, North Carolina Nursing Association.

Awards and Honors -Academic Dean’s List/Waynesburg College (1994-95), Waynesburg, PA 15370.

Presentations -“Smokeless Tobacco and Rural Adolescence”; Waynesburg College School of Nursing, 1995. “Euthanasia”, For “Nursing Ethics”, a senior level class, Waynesburg College School of Nursing, 1996.

Publications -“Euthanasia”, a video-taped presentation, submitted and accepted by the National League of Nursing from Waynesburg College School of Nursing, presentation group 4, class of 1996.

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