Renee Workings Email and Phone Number
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Very strong Senior Clinical Research Professional with significant Education and focused Clinical Experience. Possesses excellent Clinical Research expertise for Medical Device, Pharmaceutical and IVD fields. Published Medical/Technical/Scientific Writer. Experienced in R&D, Project Management, and Clinical Site Management in multiple broad therapeutic indications. Professional /Clinical Skills: - Clinical Operations/Site Management (18 years); proven ability to interact effectively with all investigators and cross-functional teams within Sponsor/CRO/University Research Hospitals/KOLs, etc.- Medical/Scientific Research (15 yrs)- Statistical Analysis (8 yrs)- Published Professional Medical Writer, experienced with Editing & Publishing process (16 yrs)- AMWA member with thorough knowledge of GCP, GLP, ICH, ISO guidelines, MDD/EU MDR and additional U.S. and international clinical regulatory requirements. Meticulous detail towards compliance to FDA 21 CFR regulations and ICH GCP E6 (R2), ISOxxx- Strong work ethic and demonstrated ability to deliver assignments on time- Effective Communicator in-person and via professional documentation- Proven ability to mediate/resolve trial clinical issues with all clinical team members- Possess data management skillset for development, review, validation and verification - Extensive experience with development of clinical research documentation (SOPs, WIs, FDA support docs, CRFs, Study Forms/Templates, Training Materials, Abstracts, Technical Posters, Manuscript writing and publishing process)- Development of creative and innovative strategies; Individually, on Teams, and in Supervisory capacities- Experienced with multiple research EDC and eTMF systems- Proficient with all office and documentation systems (MS Office, Word, Excel; Google Office systems, Box, Endnote, PubMed, ClinicalTrials.gov, etc))- Technical/Clinical Instructor (15+ yrs); able to train and mentor clinical staff- Seasoned Traveler with ability to travel extensively and spontaneously. Direct access to two international airports within 40 mins. - Advanced Degree In Life Science; Applied Cognition and Neuroscience – University of Texas at Dallas
Icon Plc (Formerly Aptiv Solutions)
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- aptivsolutions.com
- Employees:
- 212
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Senior Clinical Research Associate And Senior Site ManagerIcon Plc (Formerly Aptiv Solutions)Rockwall, Tx, Us
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Senior Clinical Research Associate/Senior Site ManagerIcon Plc (Formerly Aptiv Solutions) Jul 2014 - PresentMarlborough, Massachusetts, UsContracted to Leica Biosystems; Senior Clinical Site Manager - In vitro diagnostics (IVD) clinical research; Multi-Center Study to Evaluate the Accuracy and Precision of the Aperio ePathology System for Primary Diagnosis of Formalin-Fixed Paraffin Embedded Tissue Sections. ePathology, WSI to LM specimen comparison for diagnostic concordance. 5 clinical sites across 4 time zones. Experienced with Aperio AT2 DX instrumentation. Acumen eCRF and medical management software. Managed all aspects of clinical research; site selection, Monitoring visits – SQV/SIV/IMV/COV, data management, protocol compliance, GCP, ICH, IP accountability & disposition. performed monitoring of clinical sites for continued compliance with applicable local regulatory requirements and ICH/GCP guidelines. Managed remote and on-site essential site documentation completion, collection and submission to CTMS. Performed source document verification and query resolution.Contracted to Roche Diagnostics; Senior Regional CRA for multiple concurrent US and International IVD (CDx) clinical protocols. Study indications included Oncology, Endocrinology, Cardiology and Neurology. Experienced with Electrochemiluminescence Immunoassays, Reagents and specified Biomarker research. Skilled w/ Roche 6000 analyzer e601; Medrio, Veeva Vault (eTMF), eCRF implementation. Performed IP accountability, dispensation, and compliance at the investigative sites. Reviewed and verified and validated accuracy of clinical trial data collected. Developed, performed, and assured documentation of, technical training of research investigators, technicians and staff. Very experienced with complete clinical trial support and management from SQV, SIV, IMV through Data-lock and COV. Completion of timely accurate study visit/status reports.
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Senior Clinical Research AssociateJohnson & Johnson 2012 - 2014New Brunswick, Nj, UsProvident Research CRO; Sourced to Johnson & Johnson DePuy. Regional medical device CRA/monitor for multiple clinical protocols (IDE, PAS and 522s). Concurrently monitored 6 protocols and 22 clinical research sites. Orthopaedic TH Arthroplasty indication. FDA 522 surveillance studies. Managed complete clinical research trial lifecycle from investigator/site selection, essential document collection, budgeting, contract negotiation, patient recruitment, informed consent, monitoring SIV/IMV, compliance assurance, data management, data validation and lock, through site close out (COV). -
Senior Clinical Research ScientistSt. Jude Medical Neuromodulation Division (Abbott Laboratories) May 2009 - Nov 2012Neuromodulation, Deep Brain Stimulation, Cortical Stimulation, Spinal Cord Stimulation, Movement Disorders Therapy.Produced and conducted Training Initiatives and field support for Neuromodulation research studies employing Deep Brain Stimulation for Parkinson’s disease, ET, Dystonia, Major Depressive Disorder; and Spinal Cord Stimulation for treatment of Chronic Pain. Developed Physician Initiated Clinical Research. Collaborated with physician researchers for the writing/publishing of professional clinical abstracts, presentations and manuscripts. Supported Monitoring activities of CRAs and Data Management for FDA submission, and US / OUS compliance requirements. Responsible for professional development and production of SOPs, WIs, and adherence to GCP, Research Protocols, CRFs, Informed Consent, etc. Skilled with assessments and outcome measures such as UPDRS, Hohn & Yahr, Beck BDI, ADL, Columbia Scale (C-SSRS), Hamilton (HRSD), QIDS-C/QID-SR, MMSE.
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Clinical Research Associate / Clinical SpecialistCoretex Neuroscience Associates 2000 - 2009• Clinical Research Coordinator; Neurology Specialists of Dallas, P.A. Texas Health Presbyterian Hospital Dallas - Neurological Research in Parkinson's Disease, movement disorders and Alzheimer's disease, Epiepsy, MS, and other neuropathology. Clinical Medical Device & Pharmaceutical Drug Trials.• OEN – Dallas/Houston, Texas Medical Technical Advisor “Prescription for Health” Television Series. Gamma Knife Neuro-oncology Surgical Program with W. Robert Hudgins, M.D. Attending Neurosurgeon, Presbyterian Hospital of Dallas, Texas • Aage Møller, Ph.D. – Brain and Behavioral Sciences Center – University of Texas Dallas, Texas Medical Writer/Editor. Medical Research Books include:Møller, A. “Neural Plasticity and Disorders of the Nervous System” – Cambridge Univ. Press (2005) Møller, A. “Intraoperative Neurophysiologic Monitoring” – Humana Press, Inc. (2006)
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Medical Clinical Consultant / Senior Project ManagerAnalysts International Corp. Feb 1994 - Dec 2000Minneapolis, Mn, UsELI LILLY/Control Diabetes Corp. -- Clinical Systems Project Manager; Dia-Trac (TM) DSME System. MCKESSON CORP/FOXMEYER PHARMACEUTICALS -- Senior Project ManagerHEWLETT-PACKARD -- Project Mgr./Technical Writer. HP High performance computing division for biomedical informatics research in neuroscience, breast cancer, prostate cancer, cardio-vascular disease, diabetes, and reproductive biology. ABBOTT LABORATORIES -- Senior Project Manager; Medical Devices; AxSYM immunoassay system and the collaborative Abbott Maestro workstation medical devices.
Renee Workings Skills
Renee Workings Education Details
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The University Of Texas At DallasApplied Cognition And Neuroscience -
Whitworth UniversityDevelopmental Disabilities
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Ygnacio Valley High SchoolGeneral Studies
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The University Of Texas At DallasNeuroscience (*In Progress)
Frequently Asked Questions about Renee Workings
What company does Renee Workings work for?
Renee Workings works for Icon Plc (Formerly Aptiv Solutions)
What is Renee Workings's role at the current company?
Renee Workings's current role is Senior Clinical Research Associate and Senior Site Manager.
What is Renee Workings's email address?
Renee Workings's email address is rw****@****ail.com
What is Renee Workings's direct phone number?
Renee Workings's direct phone number is +197294*****
What schools did Renee Workings attend?
Renee Workings attended The University Of Texas At Dallas, Whitworth University, Ygnacio Valley High School, The University Of Texas At Dallas.
What are some of Renee Workings's interests?
Renee Workings has interest in Scuba Diving Master Instructor, Teaching Sailing, Racing Sailboats.
What skills is Renee Workings known for?
Renee Workings has skills like Medical Devices, Clinical Research, Clinical Trials, Neuroscience, Neurology, Diabetes, Hospitals, Pharmaceutical Industry, Surgery, Clinical Trial Management, Life Sciences, Clinical.
Who are Renee Workings's colleagues?
Renee Workings's colleagues are Christina Caffelle, Nicola Thompson, Sofia Makesh, Jennifer Batzer, Kalpana J, Manjusha A, Chie Chie.
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