Responsibilities as a Clinical Research assistant are to inform trial subjects and securing their consent, conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator. Day to day work for a research assistant includes blood draws, process blood specimens, ship blood specimens to laboratory, ECG, obtaining demographics, vitals, documenting adverse events/ serious adverse events (AE/SAE) and data sourcing from the subject's lab results, comments, and observations. This information is then input into electronic data capture (EDC) for the sponsor company's to collect and formulate presentation to the FDA.
- Clinical Research Assistant at National Institute of Clinical Research
- Outpatient Case Management Coordinator at Regal Medical Group
- Medical Assistant Back and Front Office at United Surgical Partners Inc
- Medical Assistant Back and Front Office/ Ward Clerk (Temporary) at Henry Mayo Newhall Memorial Hospital
5 months at this Job
- Diploma - Medical Assistant
Private training organization focused on analyzing and evaluating clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives.
CLINICAL RESEARCH ASSISTANT (CRA) ORLANDO, FL
2018 - Present
This role is part of an intensive educational and training program for new CRAs. Highlights:
• Managed and responded to project related email.
• Attended project meetings, area seminars, and other meetings as necessary.
• Conducted and recorded face-to-face and/or telephone interviews with subjects, in accordance with predetermined interview protocol, data collection procedures and documentation standards.
• Identified and compiled lists of potential research subjects in accordance with study objectives and parameters, as appropriate to the individual position.
• Developed or assisted in the development of interview schedules; contacted potential subjects to introduce and explain study objectives and protocol and to arrange interviews, either in person or by telephone. ARBEITER-SAMARITER-BUND DEUTSCHLAND (ASB) ASB launched a multi-sectoral program in September 2013 to strengthen the disaster resilience of the rural population in Petit-Goave and Grand Goave through the establishment of resilient infrastructure and provisional training in the areas of safe construction practices, disaster risk reduction in schools, and food security.
- CLINICAL RESEARCH ASSISTANT (CRA) at NEW HORIZON RESEARCH SOLUTIONS
- EMERGENCY RELIEF COORDINATOR at WASH, Construction, Multi-Purpose
- PROGRAM MANAGER at
- SENIOR PROGRAM OFFICER - HAITI RECOVERY INITIATIVE at OTI
1 year at this Job
- BACHELOR'S - BUSINESS ADMINISTRATION
- Certificate of completion - Clinical Research
- Certificate in Governance and Democratic Practices in War
- Certificate in Human Resources Management
Clinical Research Assistant II
• Analyzed clinical data using designated software
• Participated in and presented virtually at research summits
• Designed and analyzed Post Join Replacement Patient Outcomes Reports
• Adjudicated post surgical complications (MI, DVT, Fracture, Tachycardia, AKI, etc.)
• Verified database input accuracy
• Maintained regulatory compliance pursuant to CME requirements
- Clinical Research Assistant II at St Francis Hospital and Medical Center- Connecticut Joint Replacement Institute
- Licensed Practical Nurse at Hospital for Special Care
- Traveling Nurse at Hospital for Special Care
1 year, 8 months at this Job
- Bachelor of Science in Bimolecular Science - Bimolecular Science
Morehouse School of Medicine (MSM), located in Atlanta, Ga., was founded in 1975 as the Medical Education Program at Morehouse College. MSM is among the nation's leading educators of primary care physicians and was recently recognized as the top institution among U.S. medical schools for its social mission.
Clinical Research Assistant II 2006 to Present
Manage the day-to-day operations of clinical trials within the center which includes laboratory operations and participant flow.
• Facilitate, conduct, and store clinical research studies materials and blood samples in Shared Use Lab.
• Oversite of the MRC Freezer Room for the Clinical Research Center and the Institution.
• Provide test results for patient diagnosis and treatment by both operating chemistry equipment and performing hand chemistries
• Perform EKG and phlebotomy on study participants
• Train Research Assistants and Clinical Coordinators on performing laboratory specimen processing.
• Instruct Research Assistants and Clinical Coordinators on collecting, managing and warehousing of specimens for long term storage
• Maintain equipment within the center, including ordering, calibrations, maintenance, and operation
• Ensure quality recording of all specimen data originating from Clinical Research Center into the Laboratory Information Data System (LIMS)
• Instructor in the Annual Skills Validation; coordinate and conduct in-service training
• Train, demonstrate and instruct staff and medical students in the performance IV insertion, Phlebotomy, and Foley Catheter. Maintain a working knowledge of all study operations within the Clinical Research Center
• Review FDA requirements, ICH and GCP guidelines for patient care in clinical trials
• Coordinate clinical activities between departments, (CVRI and Core Lab)
• Maintain infection control SOP's and ensure the protection of PHI in accordance to HIPPA and Institutional policies
• Lead support in the laboratory preparation for JCAHO Accreditation Standards and aid in the preparation of Center for Joint Commission on Accreditation of Hospitals visits.
• Participate in outreach activities related to program protocols, needs assessment, and quality assurance
• Represent the Institution during school-supported community health fairs
• Assist in participant consenting
• Preparing IRB submissions
- Clinical Research Assistant II at MOREHOUSE SCHOOL OF MEDICINE
- Cardiovascular Nurse Technician IV at Emory Midtown Hospital
- Emergency Room Nurse Technician at Phoebe Putney Hospital
13 years at this Job
- BA in Business Administration - Human Resources
- Associate of Business Management - Business Management
- - Healthcare Management Studies Honolulu
Supports nephrology clinical research coordinators with procedures, data entry, creating source documents, lab processing/shipping, and patient relations. I have experience with regulatory and informed consents.
- Clinical Research Assistant at Aventiv Research
- Lab Assistant at Millinneum Health
- Volunteer Intern at Healthy Start
- Substitute Teacher at Frontline Educators
1 year at this Job
- Masters Public Health - Research Epidemiology
- Bachelor of Arts - Biology
PROFESSIONAL CLINICAL AND CLINICAL TRIAL EXPERIENCE
• Yale University Clinical Trials Breast Oncology, New Haven, CT June 2017 - November 2018 o Clinical Research Assistant / Data Manager
• Lead CRA for IIT in Triple Negative Breast Cancer
• Management of 10+ protocols(IITs, private industry, and cooperative studies)
• Lead, plan, and participate in study training meetings (investigators/clinical staff)
• Proofreading, editing, and document formatting of protocols/informed consents
• Serve as technical and scientific expert to study site staff, investigators, and other clinical staff regarding protocol and medical imaging questions.
• Statistical analysis, reporting, and authoring publications
• Internal audits and remote monitoring of satellite care centers
• Follow up with monitors and sites to ensure all recommendations/requests for additional information are resolved.
• Abide by GCP and ALCOA-C
- Clinical Research Assistant / Data Manager at IIT in Triple Negative Breast Cancer
- Translational Clinical Radiology Intern; Invented original stroke model to train at University of Connecticut Health Center/School of Medicine
- Graduate Clinical Researcher (Nuclear Medicine) at Duke University Graduate School Dept. of Medical Physics
- at Centre Hospitalier Universitaire Vaudois
1 year, 5 months at this Job
- MS - Medical Physics
- BS - Physics
General knowledge of clinical research work. I am certified to operate multiple clinical research equipment, thorough knowledge of GCP, data entry, QC work and Excel.
- Clinical Research Assistant at Princeton consumer research
- Assistant Store Manager at New York & Company
- Assistant Store Manager at Justice
- Key Holder at Motherhood Maternity
1 year, 2 months at this Job
• Worked with regulatory documents and managed several study protocols simultaneously
• Screened potential subjects for protocol eligibility
• Presented trial concepts and details to the subjects
• Participated in the Informed Consent process and enrollment of subjects into clinical studies
• Served as the primary liaison between investigators, clinical staff, and research subjects
• Organized lectures and attended investigator meetings
• Assisted in patient care ADMINISTRATIVE
• Organized and prepared reports related to the progress of clinical studies
• Assisted with preparation of external and internal documentation for assigned trials
• Performed work activities in compliance with ICH, FDA, and GCP guidelines and procedures
• Responsible for performing activities within project timelines, priorities, and productivity specification
• Ensured adequate protection of the rights of all subjects involved in clinical trials
• Provided instruction and training to research staff on patient recruitment and eligibility University of South Florida, College of Medicine Tampa, FL Departments of Anatomy and Neurosurgery
- Clinical Research Assistant at Advanced Research Institute
- Biological Scientist at SCIENTIFIC BENCHWORK
- at SCIENTIFIC BENCHWORK
3 years at this Job
- Bachelor of Science - Biology
- Associate in Arts degree - Mass Communications
Managing multiple observational, non-clinical, and research subject study registry studies
➢ Processing of all samples and prepares all lab specimens for shipment according to protocol
➢ Collected and maintained patient records, data collection, source documents, and case reporting forms using ALCOA standards
➢ Obtained informed consent from research study participants
➢ Screening patients to determine eligibility per I/E Criteria
➢ Worked in lab to obtain/renew cpt1 license (submitted to state Sep 2017)
- Clinical Research Assistant at California Cancer Associates for Research & Excellence, Inc
- Audiology Technician at Heiner Hearing Center
- Customer Service Representative at Alorica
- Administration / Medical Technician Assistant at Saint Agnes Medical Center
2 years, 2 months at this Job
- Associate of Science - Medical Assisting
• Performs study specific goals and timelines as assists with clinical tasks related to study-specific tests, procedures, and treatments in accordance with trial protocols, FDA Regulations, and ICH/GCP Guidelines.
• Communicates appropriately and effectively with subjects, investigators, Project Managers, Clinical Research Coordinators (CRC's) and other TRI staff to serve as a participant advocate by reporting any participant needs, concerns, abnormalities, or adverse events
- Clinical Research Assistant Nurse at Translational Research Institute
- Surgical Nurse, LPN at Sono Bello
- Med/Treatment Nurse, LPN at Trinity Regional Rehab Center
- Clinical Nurse, LPN at Consulate Health Care of Lakeland
2 years at this Job
- ADN - Professional Nursing
- Diploma - Practical Nursing
- B.S. - Child Development and Family Studies