CLINICAL STUDY COORDINATOR II Professional Background Clinical professional proven ability work diverse clients staff. Recognized capacity learn willingness take new challenges responsibilities. Interested advancing personally professionally Clinical Research field. Skill Highlights Microsoft Office applications Proficiency multiple CTMS, eCRF, EDC, IWRS/IXRS platforms Professional Experience Clinical Study Coordinator II October 2015 Current Company Name － City State Coordinate clinical trials Surgical Research department primary focus Cardiovascular Vascular device related studies. Communicate closely surgical staff, pharmaceutical companies, surgical device manufacturers contract research organizations. Author informed patient consent forms clinical trials, accordance Internal Review Board (IRB) trial sponsor standards. Monitor studies ensure continued compliance federal IRB regulations. Author IRB clinical trial submission, planned changed, continuation end study forms. Collect data patient medical records, examinations procedures, prepare complete sponsor's clinical report forms. Monitor document AE SAE occurence submission appropriate entities. Responsible device drug accountability study. Communicate closely hospital pharmaceutical service ensure adherence pharmacy ans sponsor protocols. Introduced department efficient improved patient payment process. Created department wide documents improve trial efficiency including AE SAE monitoring source documents, proof patient payment forms, temperature monitoring logs drug/device storage. Assisted trained fellow staff use Epic EHR/EMR systems. Clinical Research Coordinator I November 2014 October 2015 Company Name － City State Coordinated pharmaceutical Phase II, III, IV clinical trials across multiple therapeutic areas, collaborating closely physicians staff, representatives pharmaceutical companies, contract research organizations academic institutions. Developed materials tools necessary appropriately carry study procedures including source document development, study timelines study related procedure strategies execution plans. Interviewed recruited patients studies following protocols established jointly study staff project sponsors. Ensured materials clinical trial protocol available subject enrollment properly maintained. Maintained extensive patient contact, via telephone written correspondence. Monitored patients track follow-up visits, record AE SAE's patient outcomes. Performeded specimen collection, processing shipment biological specimens. Experience multiple therapeutic areas including: Asthma, COPD, Women's Health, Hyperlipidemia, Gastrointestinal, Gout, Diabetes, Immunology Vaccine trial studies. Exercise Specialist July 2013 October 2014 Company Name － City State Supervised exercise sessions phase II III cardiac rehabilitation patients, including monitoring cardiac telemetry unit, response exercise, patient safety. Conducted patient orientations, prescribe cardiovascular strength training exercise tailored individual needs patient. Provided developed educational services materials. Oversaw student internship program, develop educational materials, assess student learning. Performed clerical duties including billing, insurance verification patient registration. Cardiovascular Medical Technician July 2013 March 2014 Company Name － City State Conducted noninvasive cardiovascular testing procedures including; exercise pharmacologic stress echos, exercise pharmacologic nuclear stress tests tilt table testing. Prepared patients 24-hour holter 30-day event monitor services, conducted inpatient outpatient ECGs. Exercise Specialist May 2013 October 2013 Company Name － City State Consulted patients exercise health promoting behavior. Designed customized training programs addressed health problems, risk factor modification, specific injuries/physical limitations, fitness goals. Performed analyzed DEXA body composition scans. Fitness Specialist January 2013 May 2013 Company Name － City State Taught group exercise classes senior independent, assisted, Alzheimer/dementia residents promote functional, aerobic, strength flexibility benefits. Provided individualized exercise instruction requested residents based goals needs. Monitored wellness center promoted participated resident activity department events. Fitness Specialist December 2012 August 2013 Company Name － City State Measured clients' fitness completing comprehensive fitness evaluations acquiring physician clearances based risk stratification needed. Designed customized client programs meet individual fitness needs. Served point reference fitness expertise within facility. Clinical Exercise Physiologist Intern July 2012 January 2013 Company Name － City State Clinical Exercise Physiologist Intern September 2010 November 2010 Company Name － City State Group Exercise Class Coordinator/Instructor April 2010 June 2011 Company Name － City State In charge overall efficiency class procedures including: instructor replacement training, class scheduling cancellation, emergency procedures, documentation organization paperwork class supplies. Led exercise groups 40 participants aged 50 years older; Educated participants proper exercise form health benefits; Endorsed local community health promotion programs. Education Training Master Science Clinical Exercise Physiology June 2012 Ohio University － City State Clinical Exercise Physiology Graduate Recruitment Scholarship Recipient Student Exercise Physiologist O'Bleness Memorial Hospital Heartworks Cardiac Rehab Student Fitness Specialist Ohio University WellWorks Fitness Center WellWorks Risk Reduction Program Health Coach/Personal Trainer Bachelor Science Kinesiology May 2011 Michigan State University － City State Specializations Health Promotion Bioethics Humanities Member Phi Epsilon Kappa, Academic Fraternity Kinesiology Students Student Teaching Assistant Cadaver Anatomy Lab 2011-2012 Certifications BLS Healthcare Provider Completion Phlebotomy Skills Healthcare Professional Course CITI GCP Certified IATA Certified Skills Academic, administrative support, agency, back-up, benefits, billing, Cancer, clerical, clinical research, Coach, Oral, community health, client, clients, data collection, Diabetes, documentation, educational materials, functional, GCP, HR, Immunology, instruction, instructor, insurance, managing, Market, materials, Microsoft Office applications, Page, patient safety, Phlebotomy, Physiologist, prescribe, processes, promotion, protocols, Recruitment, rehabilitation, Safety, scheduling, specimen collection, Surgery, telemetry, Therapy, Trainer, training programs, Vaccine, composition