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Click here or scroll down to respond to this candidateCandidate's Name
Senior Clinical Research Associate IIStreet Address Woodmont DriveMarietta, Georgia Street Address
PHONE NUMBER AVAILABLEEMAIL AVAILABLECANDIDATE PROFILECandidate's Name being an integral part of the Clinical Research TeamTHERAPEUTIC EXPERIENCETherapeutic Units &Indications (yrs.) Cardiovascular, Metabolic and Critical Care: Diabetes Mellitus 2 (7 yrs), Heart Failure (0<1 yr), End Stage Hypertension (2 yr), coronary artery disease(CAD)-(1 yr) General Medicine: Orthopedic Cancer Pain (2 yrs.), Ulcerative Colitis (2 yrs), GERD (3 yrs.), Age related Macular Degeneration (2 yrs.) Infectious and Respiratory diseases: Community Acquired Pneumonia {1 yr), Nosocomial Acquired Pneumonia (1 yr), Helicobacter Pylori {2 yrs), Allergic Asthma (5 yrs), COPD (5 yrs), Seasonal Allergic Rhinitis (5 yrs), Perennial Allergic Rhinitis, Hepatitis B (2 yrs) Rare Dusease: Gaucher Disease (1 yr.) Neuroscience: Epilepsy (3 yrs), Relapsing Multiple Sclerosis (1 yr), Stroke (2 yrs), Bi-polar I and II (3 yrs), Post traumatic stress disorder (1 yr), MDD (2 yrs), Parkinsons Disease (2 yrs), Alzheimers Disease, (2 yrs), MDD (1 yr), Migraine Headache Pain (1 yr), Sleep Apnea (1 yr), Schizophrenia (1 yr)Study Phases PHASE I, II, III, IV Studies including double-blind, open-label, randomized, registry and observationalPatient Populations Pediatrics, Adult, Inpatient, Outpatient, Critical Care and Elderly PROFESSIONAL EXPERIENCEKPS ON ASSIGNMENT WITH PPD, MARIETTA, GEORGIA, USA On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD. SENIOR CLINICAL RESEARCH ASSOCIATE JAN 2024 TO 17MAY2024 (Limited Contract) As a Senior Clinical Research Associate performs and coordinates assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conducts site visits to determine protocol and regulatory compliance and prepares required documentation. Develops collaborative relationships with investigative sites and client company personnel.SYNEOS HEALTH, MARIETTA, GEORGIA, USA SENIOR CLINICAL REARCH ASSOCIATE, MAY 2022 NOV 2023 As a Senior Clinical Research Associate performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conduct site visits to determine protocol and regulatory compliance and prepares required documentation. Develop collaborative relationships with investigative sites and client company personnel.UBC, MARIETTA, GEORGIA, USA SENIOR CLINICAL REARCH ASSOCIATE, JUNE 2019 APRIL 2022 As a Senior Clinical Research Associate performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conduct site visits to determine protocol and regulatory compliance and prepares required documentation. Develop collaborative relationships with investigative sites and client company personnel.COVANCE, MARIETTA, GEORGIA, USA SENIOR CLINICAL REARCH ASSOCIATE, JANUARY 2012 JUNE 2019 As a Senior Clinical Research Associate performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conduct site visits to determine protocol and regulatory compliance and prepares required documentation. Develop collaborative relationships with investigative sites and client company personnel.PPD, MARIETTA, GEORGIA, USA SENIOR CLINICAL REARCH ASSOCIATE, JULY 2010 DECEMBER 2011 As a Senior Clinical Research Associate performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conduct site visits to determine protocol and regulatory compliance and prepares required documentation. Develop collaborative relationships with investigative sites and client company personnel.QUINTILES, MARIETTA, GEORGIA, USA ASSOCIATE MANAGER OF CLINICAL OPERATIONS, FEBRUARY 2007 OCTOBER 2009 Provided line management for a team of office based CRAs Clinical Operations personnel in the conduct of Phase I through Phase III clinical trial projects. Oversaw the development of clinical staff by teaching, mentoring and performing six-month and annual performance evaluations, as well as attended multiple on-site support and assessment visits for CRAs. Monitored overall workloads of direct reports. Identified training needs of direct reports through the creation and ongoing assessment of the training plan and records. Accompanied each CRA on site monitoring visits and complete assessment of on-site monitoring performance. Reviewed expense reports and timesheets; tracked vacation, sick leave, and non-billable time. Served as source of scientific and therapeutic expertise for Quintiles Clinical staff. Served as liaison between Quintiles, Inc. project teams and pharmaceutical clients. Oriented new employees to Quintiles policies and procedures, Quintiles specific data bases, and other specific job responsibilities required for Quintiles CRAs CLINICAL TEAM LEAD, NOVEMBER 2006 TO FEBRUARY 2007 As a Clinical Team Lead ensured all aspects of the clinical trials were completed according to the protocol and sponsor specifications. Create CMP and other tools required for use on the trial by the project team. Responsible for creating site assignments and ensured compliance with timelines for all types of monitoring activities such as PSV, SIV, RMV and COVs. Complete review of MVRs and ensured final documents were completed per guidelines. SENIOR CLINICAL REARCH ASSOCIATE, APRIL 2003 NOVEMBER 2006 As a Senior Clinical Research Associate performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conduct site visits to determine protocol and regulatory compliance and prepares required documentation. Develop collaborative relationships with investigative sites and client company personnel. CLINICAL REARCH ASSOCIATE, AUG 2001 APR 2003Responsible for on-site monitoring of clinical drug trials. Ensured adherence to good clinical practices, investigator integrity, and compliance with all protocol requirements and study procedures. Verified Case Report Forms (CRFs) against source documents for completeness and accuracy. Reviewed regulatory documents for availability and accuracy. Performed Clinical Trial Materials accountability. Maintained communication with site personnel, project team, and sponsor. SPECTRX, ATLANTA, GEORGIA, USA CLINICAL REARCH ASSOCIATE, MAY 2000 FEB 2001Responsible for on-site monitoring of clinical drug trials. Ensured adherence to good clinical practices, investigator integrity, and compliance with all protocol requirements and study procedures. Verified Case Report Forms (CRFs) against source documents for completeness and accuracy. Reviewed regulatory documents for availability and accuracy. Performed Clinical Trial Materials accountability. Maintained communication with site personnel, project team, and sponsor. GEORGIA NEUROLOGY ASSOCIATES, ATLANTA, GEORGIA, USA SITE DIRECTOR/LEAD STUDY COORDINATOR, SEP 1998 DEC 1999 Completed site management for all study activities and research personnel. Responsible for coordination of clinical drug trials. Ensured adherence to good clinical practices, and compliance with all protocol requirements and study procedures. Completed Case Report Forms (CRFs) with information gathered in source documents for all subjects. Maintained regulatory documents for availability and accuracy. Completed Regulatory start up and submission packets for submission to IRB. Performed Clinical Trial Materials accountability. Maintained communication with project team, and sponsor DIGESTIVE CARE ASSOCIATES, MARIETTA, GEORGIA, USA SITE MANAGER/LEAD STUDY COORDINATOR, SEP 1996 SEP 1998 Completed site management for all study activities and research personnel. Responsible for coordination of clinical drug trials. Ensured adherence to good clinical practices, and compliance with all protocol requirements and study procedures. Completed Case Report Forms (CRFs) with information gathered in source documents for all subjects. Maintained regulatory documents for availability and accuracy. Completed Regulatory start up and submission packets for submission to IRB. Performed Clinical Trial Materials accountability. Maintained communication with project team, and sponsor. GEORGIA ALLERGY AND RESPIRATORY, ATLANTA, GEORGIA, USA CLINICAL REARCH LEAD STUDY COORDINATOR, JUN 1994 AUG 1996 Responsible for coordination of clinical drug trials. Ensure adherence to good clinical practices, and compliance with all protocol requirements and study procedures. Completed Case Report Forms (CRFs) with information gathered in source documents for all subjects. Maintained regulatory documents for availability and accuracy. Performed Clinical Trial Materials accountability. Maintained communication with project team, and sponsor.ATLANTA MEDICAL ASSOCIATES, ATLANTA, GEORGIA, USA CLINICAL REARCH COORDINATOR SEP 1992 JUN 1994Responsible for coordination of clinical drug trials. Ensure adherence to good clinical practices, and compliance with all protocol requirements and study procedures. Completed Case Report Forms (CRFs) with information gathered in source documents for all subjects. Maintained regulatory documents for availability and accuracy. Performed Clinical Trial Materials accountability. Maintained communication with project team, and sponsor.ATLANTA ALLERGY CLINIC, ATLANTA, GEORGIA, USA CLINICAL REARCH COORDINATOR SEP 1992 JUN 1994Responsible for coordination of clinical drug trials. Ensure adherence to good clinical practices, and compliance with all protocol requirements and study procedures. Completed Case Report Forms (CRFs) with information gathered in source documents for all subjects. Maintained regulatory documents for availability and accuracy. Performed Clinical Trial Materials accountability. Maintained communication with project team, and sponsor.UNIVERSITY HOSPITAL, AUGUSTA, GEORGIA, USA LPN/CHARGE NURSE, JUN 1985 JUL 1987Administer Medications, Oversee CNA staff, Direct patient care EDUCATION Augusta Technical College-Augusta, Georgia-USAPractical Nursing Diploma-APR-1985LICENSE(S) AND CERTIFICATE(S)Vaccines Academy Certificate Program, 2024. A comprehensive global development program, designed to ensure that candidates reach a high level of understanding and performance within the vaccines therapeutic area; program content provided in a blended learning format with questions built into the modules to ensure learner understanding. Modules include: Basic Immunology for Vaccines, Vaccines Types, Vaccines Clinical Development, COVID-19 Vaccines, General Vaccines, and Trial Considerations. LANGUAGE(S)English Proficient:THERAPEUTIC EXPERIENCE AND EXPERTISEAllergy: Seasonal Allergic Rhinitis and Perennial Allergic Rhinitis Cardiology/Vascular Diseases: Coronary Artery Disease, End Stage Hypertension Digestive: Ulcerative Colitis, Gastroscopic Esophageal Reflux Disease, Hepatitis B, Endocrinology/Metabolic, Diseases: Diabetes Mellitus 2 Infectious/Parasitic Diseases: Community Acquired Pneumonia and Nosocomial Acquired Pneumonia Analgesia: Orthopedic Cancer PainNervous System: Migraine Headache, Relapsing Multiple Sclerosis stroke, Parkinsons, Alzheimers Ophthalmology: Age Related Macular DegenerationPsychiatry/Psychology/Mental Disorders: Bi-polar I and II, MDD, Schizophrenia, Post Traumatic Stress DisorderRespiratory: COPD, AsthmaADDITIONAL RELEVANT EXPERIENCEScale/Patient Reported Outcome MeasuresSponsor and FDA Audit Preparation and follow-up Experience Computer Experience: Microsoft Word, Power Point and Excel, EDC, IWRS, CTMS and eTMF |
