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