Clinical Research Associate/RN/BSN
Resume:
Gregory A. Babyak, RN, BSN
Saltsburg, PA
PROFESSIONAL EXPERIENCE
Allucent February-June 2023
Senior Clinical Research Associate
Clients; LAVA Therapeutics. IDEAYA Therapies.
Responsible for all aspects of clinical research monitoring for oral and injection cell-based study utilizing the CAR-T platform. Responsibilities included but were not limited to; Start-up, routine monitoring, and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits for Phases II-IIIB in the USA and Canada.
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.
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 and mentor new CRAs.
EDC experience including BioClinica, Medidata, Trial Interactive, NetExtender, Solabs, CTMS, Inform, PhaseForward IV, Impact, Recruitment Tracker, Medidata, Clinphone, Oracle RDC, IVRS and electronic subject diaries including specific attention to conducting Power Point presentations.
Innovaderm October 2021-February 2023
Senior Clinical Research Associate
Clients; Arcutis.
Responsible for all aspects of clinical research monitoring for four arms of a dermatological study including start-up. routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits for Phases II-IIIB in the USA and Canada.
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.
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 and mentor new CRAs.
EDC experience including BioClinica, Medidata, Trial Interactive, NetExtender, Solabs, CTMS, Inform, PhaseForward IV, Impact, Recruitment Tracker, Medidata, Clinphone, Oracle RDC, IVRS and electronic subject diaries including specific attention to conducting Power Point presentations.
Senior Clinical Research Associate/Consultant August 2015-May 2019
Clients: Abiomed, Cognitive Research Corporation (CRC), George Clinical US, Juno Therapeutics, Quintiles, PAREXEL, Clinipace Worldwide, GENO, LLC
Projects:
Cardiac Device project.
CNS / Driving Simulator / Sleep Studies.
Oncology projects; Metastatic/Advanced RCC, CINV via AC naive Breast Cancer in phase I.
Leukemia projects/autologous bone-marrow acquired stem-cells via laboratory processes.
Rescue allergy study involving “Risk-Based” data.
Oncology study utilizing bone-marrow and protein isolation/activation vaccine
Cardiac and oncology device projects, isolating bone-marrow acquired stem cells.
Respiratory delivery device study for PAH patients.
Responsible for all aspects of study site monitoring including start-up. routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits for Phases II-IIIB in the USA and Canada
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.
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.
EDC experience including CTMS, Inform, PhaseForward IV, Impact, Recruitment Tracker, Medidata, Clinphone, Oracle RDC, IVRS and electronic subject diaries including specific attention to conducting Power Point presentations.
DOCs Global, Inc., Raleigh, NC Mar 2011-Mar 2014
Senior Clinical Research Associate/Consultant
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, Dermatology, 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
Dermatology, Rheumatology, Pulmonary, CNS, Oncology, Ophthalmology and Immunology in phases II, IIb, III, and IIIb.
TAP Pharm., Vernon Hills, IL Feb 2003-04
Senior Clinical Research Associate/Consultant
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, 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.
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. TIA; 2 studies (1 rescue study), phase II/IIb. CVA; 2 studies, phase III/IIIb. Tamponade; 1 study, phase I/ II. AVI, 1 study, phs III. Pacemaker/Defib, 1 study, phs II. Stent; 1 study, phs IIb. Shunt; 1 study, phs III. Intra-Coronary Infusion; 1 study, phs II, Hemostatic implant; 1-study, phs III, COV.
Endocrinology:
IDDM; Insulin delivery system, 1 study, phase III. Hypo/Hyperglycemia, 2 studies, phs II/III. Nephritis (proteinuria); 1 study, phs II. Gout; 5 studies, phs I/II/IIb/III/IIIb.
Urology:
CUTI; 4 studies, phs I/II/IIb/III. UTI; 2 studies, phs III/IIIb. Nephritis (infection); 1 study, phs IIIb.
Immunology;
ID; 3 studies; phase III/IIIb. Wound care; 2 studies, phase III/IIIb. HIV; 3 studies, phase II/III/IIIb. Septicemia; 3 studies,1-rescue study, phase III/IIIb. Hepatitis B/C; 3 studies, phase II/IIb.
Dermatology;
Eczema/Psoriasis, 2 studies, phs II.
Ophthalmology/Otology:
Detached Retina; 2 studies, phase II/IIb. Cataract; 1 study, phase IIIb. Eye-dryness; 2 studies, phase III.
Neurology/CNS:
Bi-Polar Disorder; 2 studies, phase III/IIIb. Alzheimer’s; 2-studies, phase I/II/IIb. Epilepsy; 3 studies, phase III/IIIb. Pain Management; 4 studies, phase III/IIIb. Parkinson’s; 1 study, phase Iib.
Oncology:
Injection and Oral Cell-Based Therapy; 2-Studies, phase I. Metastatic/Advanced RCC; 1-study, phase I. CINV via Anthracycline-Cyclophosphamide (AC), 1-study, phase IIIb. Lymphoma; 4 studies, phase I//II/IIb. Melanoma/Dual-therapy vaccine; 1 study, phase IIb. Melan. /Device using hepa. Isolation; 1 study, 1-yr. contract, phase II. Leukemia (all 4-types); 4 studies, phase II/IIb. NSCLC; 1 study, phase II. Cutan. Mel. Mets. To Hepatic (liver); 1 study/rescue, phs III.
Hematology:
Anemia; 1-study, phase II. Blood Dyscrasia; 1-study, phase II.
Gastrointestinal (GI):
GERD; 2 studies, phase III. Diverticulitis; 2 studies, phase III. Ulcerative Colitis/Crohn’s Disease; 2 studies, phase III. IBS; 2 studies, phase III.
Pulmonary:
Asthma; 3 studies, phase III. COPD; 3 studies, phase III. Emphysema; 2 studies, phase III. PAH; Nitric Oxide inhaled DS weaning PGI subjects; 1-study, phs III. Allergy; Rescue Project, 1-study, phs II.
Rheumatology:
Rheumatoid Arthritis; 3 studies, phase I/II/IIb.
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.
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