EDWARD GRUDUS RN BSN ACRP-CP
614-***-**** email@example.com https://www.linkedin.com/in/edward-grudus-75175b54/ SUMMARY
Highly experienced Clinical Research Trials Coordinator and Emergency Department nurse with management experience and exceptional people skills. Versed in all aspects of Clinical Research Trials from site initiation to close out visits and storage of documentation. Desire a challenging Clinical Trials Coordinator or Research Nurse role with a Hospital or Pharmaceutical/Medical Device company. Self- motivated and dependable while achieving high performance with minimal supervision. Demonstrated the ability to complete tasks accurately and timely despite interruptions and competing demands. EDUCATION AND TRAINING
2019 Certified Association of Clinical Research Professional (ACRP--CP) 2017 Nurse Refresher Course: Cleveland State University 2009 First year completed towards Master's Degree: Medical Ethics and Law Kings College London UK
1986 Bachelors of Science: Nursing (focus on Emergency Department) The Ohio State University – Columbus Ohio
1992 Bachelors of Fine Arts: Acting
Acting Wright State University Fairborn Ohio
1992 Bachelors of Fine Arts: Directing/Stage Management Wight State University – Fairborn Ohio
RELEVENT WORK EXPERIENCE
11/2010 to 11/2011 Senior HIV Research Nurse
Guy's and St. Thomas' Hospital -- London United Kingdom
• Coordinated all Medical Research Council (MRC) HIV trials at St Thomas' Harrison Wing.
• Evaluated new trials adapting and implementing them for suitability in accordance with our available services.
• Identified patients for trials by screening patient medical history.
• Enrolled subjects for random and open label and blind trials.
• Obtained Informed Consent from patients ensuring understanding of possible benefits, risks, side effects, appointment and treatment obligations.
• Dispensed medication and monitored patients through the trial for efficacy, side effects and Serious Adverse Events (SAEs).
• Collected and processed all blood/urine specimens for onsite and outsourced evaluations.
• Submitted regulatory documentation, correspondence and protocol updates to the LREC, Clinical Trials Office, and MHRA.
• Collected and recorded patient data and lab results for statistical scrutiny.
• Interacted with multi-disciplinary team to coordinate necessary study evaluations for patients including appointments, radiology, laboratory, outpatient and in-patient services.
• Scheduled all follow-up and supportive care for patient discharge referrals.
• Provided study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines.
• Created Standard Operating Procedures for each study or protocol, and procedural operations of the clinical trial office.
• Administered/Interpreted psycho-social standardized tests.
• Interoperated data for translational research and disease progression studies. 06/2005 to 08/2010
Senior Oncology Research Nurse
Royal Free Hospital moving to University College London Hospital (UCLH) -- London United Kingdom
• Lead Research Nurse—trained, mentored and supervised trial requirements to other nurses (including those new to the research process), and ancillary staff in the Phase 1 Clinical Trials Office. Team Leader for ADEPT trial – a monoclonal targeted therapy for CEA+ GI tumors.
• Conducted and implemented Phase I/2 clinical trial protocols in the department of oncology.
• Administered oral, IV (drip/push) non-approved and approved chemotherapy agents including phase I and 2 experimental cytotoxic and biological agents involving targeted monoclonal antibodies, radio-isotypes, and small molecule inhibitor agents.
• Performed phlebotomy and processing of patient specimens for pharmaco- kinetics, including centrifugation, aliquoting, storage, and shipping to outside facilities per UK and EU regulations. Acquired bedside ECGs.
• Identified pre–trial screening of potential patients, obtaining Informed Consent.
• Identified and documented Adverse/SAEs, developed programs of patient care and education, assisted in the writing of trial protocols and amendments, Patient Information Sheets and Consent Forms, Standards of Practice (SOP) and their submissions to LREC, MREC, R&D, solving issues with Government sponsors: CRUK, NCRN, MRC, and commercial sponsors.
• Monitored and reported risk assessment for trials and related procedures.
• Ensured all code of ethics were met for regulatory documentation per MHRA, NREC, and GCP guidelines, including case report forms and Investigator Files, collection of data and data transfer, monitoring and reporting SAE's.
• Assisted in the analysis of research results and interpretation for publication and presentation at international conferences.
• Increased continuity of care with the re-infrastructure of early phase clinical trials between the inpatient UCLH and outpatient Rosenheim and the new UCLH Cancer Institute.
• Planned and contributed blue print designs for the Royal Free Hospital with UCLH merger to create a larger and more comprehensive Phase1oncology trials unit.
• Continuously updated skills travelling to conferences to learn and incorporate new practices into daily operations.
• The ability to bring smiles to client’s faces when they needed it the most—in response, received a large number of the tackiest snow globes you can imagine from around the world in appreciation.
CRUK ADEPT CEA + GI tumors Phase 1
CRUK CHT-25 Lymphoma Phase 1
NCRN CHRONICLE Rectal Cancer Phase 3
Royal Free Trust Proteomics Translational Blood Study MRC COIN Colorectal Phase 3
OCTO QUASAR2 Colorectal Phase 2
MRC PICCOLO Colorectal Phase 3
CRUK PARP Breast/Ovarian Phase 2
Astra-Zeneca Recentin Multi-site Phase 1 PK study
PPh Philogen L-19 radiolabel Multi-site Phase 1
10/1999 to 05/2002 HIV Research Nurse
HIV Institute for Research and Treatment California Pacific Medical Center, Davies Campus San Francisco, California
• Managed various HIV drug trials (phase II, III, IV, open label compassionate use) including screening appropriate patient placement, enrollment, clinic appointments, obtaining informed consent, collection and recording data for CRFs.
• Presented new trial proposals to the IRB, and all follow-up regulatory documentation in accordance with GCP and FDA, and SOP guidelines.
• Performed investigative site file reconciliation queries from Sponsor and IRB.
• Cross referenced site-related essential documents reviewing them for content, consistency with other documents, and compliance with appropriate local regulatory bodies, ICH guidelines, project SOPs and Sponsor requirements.
• Prepared and presented to the IRB applications and amendments including protocol/informed consents.
• Reported Adverse/Serious Adverse Events to Sponsor/IRB.
• Collected and processed specimens including phlebotomy for PK studies.
• Verified drug accountability logs and storage requirements.
• Dispensed antiretroviral drugs and ensured inventory and proper safety storage.
• Scheduled inpatient/outpatient care visits, including hospice care, during and at conclusion of the trial.
• Performed ECG testing, and scheduled trial related radiology exams per prerequisite requirements.
• Also conducted trials for Hepatitis C and Oncology. Trials Conducted:
Gilead Tenofovir HIV-Phase II-IV
Roche Valocyte Herpes-Phase III
Abbott ABT-378/r HIV-Phase III
Astra-Zeneca Iressa Lung Cancer-Phase III/IV
Agouron AGL 1549 HIV Phase III
Diagnostics-Oncology Viro-Cept Viral Load Test HIV Phase II Merck Agenerase/Ritonovir HIV-Phase
Romark NTZ Cryptosporidium-Phase III
10/1997 to 05/2003 Emergency Room Nurse (and HIV Research Nurse 1999 to 2003) Davies Hospital (California Pacific Medical Center)—San Francisco, California
• Level 2 Emergency Room
• Triaged incoming patients to assign appropriate level of care
• Advance Cardiac Monitoring
• Care of emergent and non-emergent patients
• Care of Acute and Chronically ill patients including BLS and ACLS training
• Knowledgeable of basic hemodynamics. Basic IV and central line, portacath skills
• Identifying and managing life sustaining physiological functions in unstable patients
• Assess need for appropriate, ordered and obtained lab tests including blood urine and tissue samples, and report to appropriate personnel
• Oversee and mentor support staff in patient care activities while maintaining high standards of care and delegate staff duties
• Instructed patients and family and proper discharge care
• Closely monitored acute conditions
• Perfumed and reported 12 lead EKGs
• Performed basic and advanced physical assessments
• Administered infusions, medications and assisted with intubations and bedside endoscopies
• Followed infection control procedures
• Interpreted limited histories and used physical examinations to identify underlying critical issues
• Demonstrate high standards of performance including teamwork, communication and compassion
• Charge nurse on ER to include lead charge nurse duties CURRENT WORK
02/2012 to Current
Standardized Patient Program
The Ohio State University Columbus, Ohio
• Participate in mock doctor-patient encounters trained to accurately and consistently recreate the history, personality, physical findings, emotional structure and response patterns of actual patients consistent with various medical modules at a specific point in time.
• Critique oral and written skills of the medical student's performance and professionalism.
• Research case studies and disease processes to accurately and realistically portray the patient experience.
• Instruct students on performing hands on physical examinations. Office Associate
Beckenhorst Press Inc Columbus, Ohio
• This is a publisher of sacred choral music.
• Update electronic files, arrange shipment delivery and accounts receivable.
• Manage daily office operations and equipment maintenance.
• Automate office operations, managing client correspondence, record tracking and data communications.
• Manage receptionist area, including greeting visitors and responding to telephone and in-person requests for information.
• Draft meeting agendas, supply advance materials and execute follow-up for meetings and team conferences.
• Maintain up-to-date department organizational chart.
• Organize incoming and outgoing correspondence.
• Proactively identify and solve complex problems that impact management and business direction, and client satisfaction.
Evidence of efficacy of antibody directed enzyme prodrug therapy (ADEPT) in a Phase I trial in patients with advanced carcinoma. Co-author The Journal of Cancer Research 04/12/2008 http://cancerres.aacrjournals.org/content/68/9_Supplement/LB-200.1 PROFESSIONAL MEMBERSHIPS
Association of Clinical Research Professionals (ACRP) ACRP-CP Current Certification North East London Local Research Ethics Committees (LREC) from July 2006 to September 2008
Royal College of Nursing
United Kingdom Royal College of Nursing Early Phase Cancer Trials Phase 1 Unit UCLH Development Board
CONTINUING EDUCATION UNITS
Human Subjects Protection (Biomedical) 2019
Recognizing Impairment in the Workplace 2019
Human Subjects Research - Biomedical Refresher 2019 Substance Abuse and the LGBT Community 2019
BPH and Cancer Research 2019
Ethics for Healthcare Professionals 2019
Ohio Nurse Practice Act 2019
Cardiac Emergencies: Assessment, Angina, and MI 2019 Depression 2019
AIDS/HIV Current Evidence Based Practice 2019
Suicide Prevention Training for Health Professionals 2019 GCP for Clinical Trials with Investigational Drugs and Medical Devices U.S.FDA Focus 2019 All Party Parliamentary Group on Cancer
Research Clinical Trials: Advanced Approaches and Methods Radiation Safety Training for Laboratory
Biological Agent Protection
UKCRF Annual Conferences
Radiation Protection for Administration
Human Tissue Act
ASCO attendance, Atlanta Georgia
Fraud and Misconduct in Clinical Research
Risks and Harm in Research
Advanced Communication Skills in Oncology Practice Research Clinical Approaches and Methods (Advanced Training) Certified to administer Cytotoxic/Chemotherapy Agents ECG Certification
Audit Preparation and Inspection
Communication in Cancer Research
Cancer Policy and Politics: Influences upon Cancer Clinical Research in NHS
Sample Management in Early Phase Clinical Trials
National Cancer Research Network Conference 2005 Birmingham Tumor Site and Trial Specific Workshop: Colorectal Cancer Good Laboratory Handling of Unsealed Radioactive Sources Advanced Good Clinical Practices
Barnett International Clinical Research Educational Series Street Drugs
Chinese Alternative Medicines
Closer Look at Lab Values
Dealing with Psychiatric Emergencies
Microsoft PowerPoint Certificate
Microsoft Word Certificate
Ohio Speech and Debate Association (College and High School level). Currently judge statewide and national tournaments Centerville Ohio High School. Coach high school speech and debate skills to students. Personally, a highly decorated public speaker winning dozens of state wide and national speech tournaments at both levels.
Suicide Prevention Program Columbus Ohio. From 1982 to 1986 answered phone lines for crisis intervention. Taught community outreach programs on suicide prevention and support of those who have experienced suicides in their communities.
CRUK (Cancer Research UK) Volunteer for Runathons supporting fund raising for Cancer Research. Camden Drug Action Team from March 2008 to 2011—provided evidence and support to eliminate illegal drug activity along Camden’s Regents Canal.
Dogs Foundation (UK) since June 2008 supporting abused and abandoned animals. PAWS (Pets Are Wonderful Support) San Francisco California. This agency supports AIDS patients who need assistance caring for their animals while the client is incapacitated. Activities included dog walking and grooming, foster care for cats, and delivering food supplies. Columbus AIDS Task Force (Now AIDS Resource Center) From 1988 to 1990 worked at an anonymous testing site drawing blood and counseling people receiving HIV test results. Clinical Research Coordinator Redcap Clinical Research Nurse CRF Documentation Nurse HIV Oncology Phase 1 2 3 trials SAE AE Cancer FDA IRB GCP Good Clinical Practices Veeva, Wingspan Trial Interactive PhlexEview, FirstDoc Documentum IRBClinical Research Trials Emergency Room Nurse Phlebotomy EKG ACRP Registered Nurse SOP Standard Operating Procedures Protocol
Nurse BSN RN AIDS HIV Oncology CRA Clinical Res earch associate Parkinsons Can cer Masters Medical ethics and Law Coordinator ACRP Phase 1 2 3 4