Research Coordinator Data Entry
Resume:
Deborah A. Appleton
Liverpool, NY 13088
Professional Experience:
Clinical Affiliate:
Saint Joseph’s and Crouse Hospitals, Syracuse, New York,
Areas of Clinical Experience:
Urology, Cardiology, Oncology, GI, Pulmonology, Vascular, Endovascular Surgery,
2021- Present- CRA/Clinical Training Specialist -Care Access
Supported all aspects of clinical trial training efforts for both the traditional and decentralized site models. Responsible for ensuring compliance and regulations. Served as a clinical trials expert for DRO and IRO teams according to corporate SOPs, GCP and FDA/ICH, and all other applicable Regulatory Guidelines. Responsibilities include managing research activities at sites, ensuring research project’s timelines and monitoring the sites activities. Monitoring and ensuring GCP, ICH and protocol training is followed. Performed various study start up activities including collection of sites appropriate regulatory documents while supporting the varies stages of protocol training and site startup. Monitoring sites data collection and ensuring potential safety related events are reported properly.
2018-Oct 2021- CRA /Manager-HOA. CNY PC
Responsibilities include managing research activities at sites, ensuring research project’s timelines and monitoring the sites activities. Conducting study initiation visits ensuring GCP, ICH and protocol training is followed. Conducting study initiation visits identifying potential sites to participate in clinical research efforts. Performed various study start up activities including collection of sites appropriate regulatory documents while supporting the varies stages of contract negotiation and budgets. Monitoring sites data collection and ensuring potential safety related events are reported properly.
Performed all tasks related to the CRA responsibilities including pre-clinical trial monitoring, budget negotiations, recruitment, screening, informed consents. Monitoring of Investigational product inventory. Ensuring potential safety related events and adverse events are reported properly, Verifying and auditing all source documentation. Areas of Clinical Experience: Urology, Cardiology, Oncology, GI, Pulmonology, Vascular, Endovascular Surgery,
2016 -2017 Clinical Research Manager- Central New York Research Corporation:
Performed all tasks related to the research manager responsibilities including -clinical trial monitoring, budget negotiations, institutional review board, recruitment, screening, enrolling obtaining informed consents; monitoring patients; Auditing IP medications; ensuring adverse event reporting and source documentation are within ICH and GCP guidelines. Ensuring CRC’s documentation and data completion. Areas of Clinical Experience: Urology, Cardiology, Oncology, GI, Pulmonology, Vascular, Endovascular Surgery,
2014- 2016 Clinical Research Coordinator- Associated Medical Professionals:
Performed all tasks related to the research coordinator responsibilities including pre-clinical trial monitoring, budget negotiations, institutional review board, recruitment, screening, enrolling obtaining informed consents; monitoring patients; administering study medications; adverse event reporting and documentation. Created source documents. Performed patient follow-up visits and CFR documentation completion.
2010-2011 Clinical Research Coordinator/ Nurse- SJH Cardiology Associates, New York
Performed all tasks related to the research coordinator responsibilities including pre-clinical trial monitoring, budget negotiations, institutional review board, recruitment, screening, enrolling obtaining informed consents; monitoring patients; administering study medications; adverse event reporting and documentation. Created source documents. Performed patient follow-up visits and CFR documentation completion.
2009-2010 Dialysis Nurse- CNY/ Liverpool Dialysis Center LLC, North Syracuse, New York
Provided direct patient care on specialty units treating patients with end stage renal failure via hemodialysis treatment and administering IV push medication. Performed sub-claven intrajugular and central venous catheter care.
2004-2009 Clinical Research Coordinator Nurse/Manager – New York Heart Center, Syracuse, New York
Performed all tasks related to the research coordinator responsibilities including pre-clinical trial monitoring, budget negotiations, institutional review board, recruitment, screening, enrolling obtaining informed consents; monitoring patients; administering study medications; adverse event reporting and documentation. Created source documents. Performed patient follow-up visits and CFR documentation completion.
2003-2004 Cardiovascular Interventional Lab Nurse- St. Joseph’s Hospital, Syracuse, New York
In the Cardiovascular Lab, I have work as a Surgical / Scrub technician, preparing the table, prepping the patient and monitoring the patient during and post procedure while maintaining a sterile field. Assisting the Cardiovascular Interventionalist with the following procedures: diagnostic catheterization, angioplasty, the placement of cardiovascular stents, intra-aortic balloon pumps, intravascular echocardiogram and closure of the access site.
1998-2003 Dialysis Nurse- St. Joseph’s Hospital, Syracuse, New York
Provided direct patient care on specialty units treating patients with end stage renal failure via hemodialysis treatment and administering IV push medication. Performed sub-claven intrajugular and central venous catheter care.
1996-1998 Manager/ Medical Assistant- Empire Vision, Syracuse, New York
Pre-screened patient and performed vision and glaucoma tests. Performed measurements for contact lens fittings and provided patients with new fit care and instruction. Office duties included: scheduling appointments and referral appointments. Performed office inventory and audits and balancing of cash draw and closeout of daily sales. Trained and supervised staff members. Bookkeeping and adjustments, data entry, patient scheduling and customer service.
Education:
Onondaga Community College
Syracuse, New York
Major: Nursing/Sciences
Licensed Nursing Program
Liverpool, New York
Bryant –Stratton Business College
Syracuse, New York
Major: Business Management/ Accounting
Additional Education:
CITI course in the protection of Human Research Subjects
Hemodialysis Core Curriculum I
OSHA Seminar (annually)
National Cancer Institute Human Participant Protections
Cardiology & Interpreting ECG’s Class
Investigators Drug Conferences
Advanced Cardiac Life Support Certification
ICH Good Clinical Practice Certification
Grants Funded:
Phase 1, Randomized, Double Blinded, Placebo –Controlled, Dose Escalation Pharmacokinetic and Pharmacodynamic Study of Ularitide in Treatment of Subjects with Acute Decompensated Heart Failure-$45,000.00 per patient.
CV185030: A Phase III, Active (Warfarin) Controlled, Randomized, Double –Blind, Parallel Arm study to evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation IND 66106-$6,000.00 per patient.
Early Glycoprotein IIb/ IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A randomized, Placebo –Controlled Trial Evaluating the Clinical Benefits of Early Front-Loaded Eptifibatide in the Treatment of Patients with Non-ST segment Elevation Acute Coronary Syndrome (EARLY ACS)-#3,000.00 per patient.
A multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs. Simvastatin Monotherapy in High –Risk Subjects presenting with Acute Coronary Syndrome (Improved Reduction of Outcomes: Vytorin Efficacy International Trial – Improve IT) -$6,000.00 per patient.
A Randomized, Double Blind, Parallel-Group, Phase 3, Efficacy and Safety Study of AZD6140 compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST Elevation Acute Coronary Syndromes (ACS) PLATO- $7,500.00 per patient.
Amgen Inc. Pharmaceuticals- A Double Blind, Randomized, Placebo –Controlled, Multicenter Study to Access the Efficacy and Safety of Darbepoetin alfa treatment and Mortality and Morbidity in Heart Failure (RED-HF) Subjects with Symptomatic Left Ventricular Dysfunction and Anemia- $24,000.00 per patient.
Additional Studies:
Torcetrapib/Atorvastatin Pfizer: A study of the efficacy of Torcetrapib/ Atorvastatin v. Atorvastatin alone.
ETC-642: A dosing/ efficacy trial for ETC-642
TIMI-38: A comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects who are to Undergo Percutaneous Coronary Intervention / TIMI-38
TCWYRE: A retro study looking at the efficacy of Taxus and Cypher Stents.
ATHENA: A trial to Assess the Efficacy of Dronedarone 400mg for the prevention of Cardiovascular Hospitalization or Death from any cause in patients with Atrial Fibrillation/Atrial Flutter (AF/AFL).
L-TAP: Pfizer: A study to look at the management of patients with dyslipidemia.
STILLER: Cypher vs. Taxus stents.
HAT: Home Automatic External Defibrillator Trial.
Early ACS: Early Glycoprotein IIb/IIa Inhibition in Non-ST segment Elevation ACS patients
Alisken: HTN study
PLATO: A study of Platelet inhabitation and patient outcomes.
IMPROVE-IT: A study to establish the Clinical benefit and safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs. Simvastatin Monotherapy in High Risk Subjects presenting with Acute Coronary Syndrome (Improved Reduction of Outcomes: Vytorin Efficacy International Trial, Improve-IT)
Ularitide Study: Acute Decompensated Heart Failure patients and the MTD of Ularitide.
EDUCATE: Endeavor drug eluting stenting: Understanding Care, Antiplatelet agents and Thrombotic Events.
CorPath: Percutaneous Robotically-Enhanced Coronary Intervention Study
HCRI DAPT: Antiplatelet vs. Placebo beyond standard of care 12 months.
SAFE PCI for Women: A study to compare the efficacy and feasibility of the trans radial approach compared with the transfemoral approach.
PROTECT: a 5 yr follow up study to evaluate the efficacy of the Endeavor stent.
Bayer 16544: A study evaluating bone scan response following treatment with Radium 223 alone or in combination with Abiraterone acetate or enzalutamide in subjects with castration prostate cancer with bone metastases.
GENOMIC Health Oncotype: A study evaluating the use of Oncotype prostate assay on treatment decision making in localized prostate cancer.
JANSSEN 3001: A study evaluating the use of JNJ-56021927 in combination with Abiraterone Acetate and patients with Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer.
BAYER 16506: A study evaluating the4 Re-treatment of radium 223 in castration- resistant prostate cancer with bone metastases.
DENDREON Corporation Protocol 12-2: This study is a comparison of two ways of delivering two FDA approved Therapies.
ALLERGAN Pharmaceuticals: A study of the safety and efficacy of Botox in Overactive bladder and Urinary incontinence.
C Defense: A study evaluating the use of a vaccine in patients at risk for Clostridium difficile. infection.
ALLERGAN 125: A study evaluating the efficacy and safety of Botox and Solifenacin in patients with overactive bladder and urinary incontinence.
POMVwC: Prevalence of Malnutrition in Veterans with Cancer.
FRAILTY: Identifying a Practical Office-based frailty assessment for pre-operative evaluation of patients with peripheral arterial disease.
PAIN study: Pilot study of SCN9A Genotype in Non-responders to Chronic pain Management.
PAION: A Phase III study evaluating the efficacy and safety of Remimazolam (CNS7056) Compared to Placebo and Midazolam in patients undergoing Bronchoscopy.
ACTELION: A mutli-center Randomized, Double Blind study to compare the Efficacy and safety of Cadazolid vs. Vancomycin in subjects with Clostridium difficile associated diarrhea (CDAD)
REBIOTIX: An open-labeled safety and efficacy assessment of Rebiotix RBX2660 (microbiota suspension) for the treatment of recurrent Clostridium difficile infection.
Licensure:
New York State Nurse, License Number 260873,
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