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Clinical Research Assistant Resume Samples
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0-5 years of experience
Accountable for overseeing Phase III clinical trials for 30 domestic transplant centers who are responsible for all post-transplant data submission to fulfill government contracts.
- Acted as liaison for 150 world-wide transplant centers submitting data for NMDP clinical studies, IRB approval, and access into international donor registry.
- Conducted monthly audits of research database, including an independent project related to cryopreservation of bone marrow and peripheral blood stem cells prior to transplant.
- Resolved all research errors on data collection forms using medical terminology in order to convert data into tangible statistics which validate program integrity.
- Improved quality control by documenting and submitting severe adverse event reports, protocol deviation forms, and quality improvement forms.
0-5 years of experience
Directed MS Access patient database of 900+ eligible participants with Asthma and comorbidities
- Adapted clinical research protocol and IRB amendments across 5 clinic sites in underserved New York communities
- Created and adapted SQL queries to trends in clinical development and changes in EPIC best available practice queries
- Conducted Spirometry tests to assess lung functionality and administer Cognitive and Health Literacy assessments
0-5 years of experience
Supported the Regulatory Coordinator with the preparation of all regulatory documents for Pharmaceutical Companies, Clinical Research Organizations and Cooperative Groups.
- Managed the patient information database for the Kimmel Cancer Center at [company name] to track patient records.
- Provided support with “Monitoring and Close Out Visits” from pharmaceutical sponsors to ensure proper compliance.
- Prepared and obtained signatures for IND safety reports ensuring patient safety.
- Maintained short and long term follow-up information for Cooperative Group Studies.
- Updated the Kimmel Cancer Center website with newly approved Clinical Trial information which resulted in availability on upcoming Clinical Trials.
- Prepared Annual Reviews and Amendments for Cooperative Groups and Pharmaceutical Companies which were submitted to the Institutional Review Board for approval.
0-5 years of experience
Managed, as part of a team, one arm of a three-year clinical trial, responsibilities included trial design,
sample processing, sample quality control, and troubleshooting
- Analyzed preliminary data using Excel, Prism, SigmaPlot, presented findings in PowerPoint regularly
- Coordinated logistic operations with clinical centers, communicated with site supervisors
- Organized and tracked over 4000 trial samples using Freezerworks
- Praised by the supervisor of Pulmonary department in consecutive formal evaluations as effective in terms of performance, teamwork, communication, and time-management
0-5 years of experience
Pre-Screened and Screened subjects to determine that clinical trial inclusion and exclusion was met prior to enrollment
- Performed informed consent process following FDA GCP guidelines
- Scheduled study visits to include Laboratory, ECG, MRI, ECHO and ultrasound appointments based on protocol schedule of assessments
- Data collection and management, collection of source documents, using and developing CRFs, registration and management of AEs, filing and archiving, managing monitoring visits, dealing with queries.
- Prepared lab kits and all required source documents for scheduled appointments
- Collected required study data including adverse event and serious adverse events and reported as necessary to Sponsor and IRB within required time frame
0-5 years of experience
Actively worked in clinical research studies such as: ♦ Silent Myocardial Ischemia.
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- Educates patients in significant aspects of the study. Ensured that the studies are conducted in accordance with the guidelines of the FDA and other regulatory agencies.
- Working with Principal Investigator to develop and implement patient recruitment strategies.
- Organized and maintained study database.
- Participated in the development of new research protocols including design and data collection system.
- Assist Principal Investigator with preparation of articles and for presentation
0-5 years of experience
Facilitated the participation of patients on PI-initiated and industry clinical trials
- Assisted with recruitment of participants in Phase 1 and Phase 2 trials
- Prepared source documentation, physician orders and necessary specimen tubes for clinic visits
- Processed, tracked and shipped specimens for testing; data entry of eCRFs and lab results in EDC and proprietary database
- Created and maintained database with Excel to organize patient information and lab results
- Scheduled and maintained travel and lodging itineraries, and coordinated clinic visits
0-5 years of experience
Investigated/assisted with 5 clinical drug trials, supporting Physicians and PAs with patient care and follow up.
Helped room 5-10 patients per hour, took vital signs, and oversaw the accurate completion of paperwork and consent forms. Scheduled appointments and responded to inquiries. Aided Head of Clinical Research with home
based visits.
- Complimented for quick ramp-up and self-motivation that provided opportunities for physicians to partake in additional trials. Personally read clinical trial manuals to rapidly advance skills and on-the-job training.
- Established trust, interviewed patients, and answered questions to determine if clinical trial eligibility
- Updated drug logs, placed orders for drugs/kits, and filled out paperwork for proper disposal. Performed
- Participated in conflict of interest training for all clinical trial drugs: BIIB023, Xoma, Krystexxa, Allure
0-5 years of experience
UNC- CH Hospital
Chapel Hill, NC – Conducted neuropsychiatric and cognitive testing on all Memory Disorder Clinic patients
- Assisted with patient visits for two clinical trial protocols
- Collected and analyzed patient data in Access database for use in scientific journal articles
- Processed blood/ urine samples in lab
- Participated at outreach events for patients and caregivers affected by cognitive disorders
0-5 years of experience
Assisted Principle Investigators in conducting clinical trials using FDA approved practices and maintained the protection of human subjects while advancing trial goals.
- Submitted invoices for applicable charges covered by funded research studies.
- Served as site lead for all assigned clinical studies ensuring that studies are delivered according to Sponsor requirements on time and with high quality.
- Prepared Institutional Review Board (IRB) materials related to initial review and approval of assigned studies.
- Assisted with regulatory compliance including preparing IRB materials for approval of protocol amendments, as well as completing IRB continuing review reports.
- responsibilities as Clinical Research Assistant for assigned trails in the Macular Function and Rose-Silverthorne Laboratory.
0-5 years of experience
Assisted clinical operations by collecting, filing, and reviewing the clinical data.
- Reviewed and collected regulatory documents.
- Assisted in preparing quarterly study payments per the study site clinical trial agreement.
- Designed and maintained the sponsor’s clinical and regulatory study cost budget database.
- Assembled Case Report Form and Regulatory Binders.
- Maintained the central files and organized other clinical data when necessary.
- Coordinated and executed Investigator (Physican) Meetings
0-5 years of experience
Independently managed and coordinated data collection and entry for research projects
- Created and maintained pediatric/adolescent bariatric surgery patient database and assisted with blood collection for ongoing genetic obesity study
- Maintained large, national, multicenter abdominal wall defects patient database
- Created and submitted all institutional review board research protocols
- Collaborated with team members to write abstracts and case studies
0-5 years of experience
Collected, analyzed, and disseminated program data and reported study progress to program stakeholders
- Maintained regulatory binders and reviewed scientific and research articles.
- Documented relevant study data on paper and/or in electronic format and maintained source documents
- Prepared reports on specific patient populations as requested by the PI for research purpose
- Organized, prepared and delivered presentations at Investigator meetings
- Liaised with sites regarding trial start-up/closeout and distributed monitoring reports within timelines
0-5 years of experience
Supported Clinical Trials to ensure adherence to approval process, related follow-ups, and ongoing maintenance.
- Maintained and updated Clinical Trials study logs as needed.
- Resolved site/data queries.
- Ensured health and safety of patients while participating in a Clinical Research Study.
- Served as the point of contact for Clinical Research Associates with periodic monitoring visits and monitoring calls.
- Maintained Regulatory Binder as well as document review and submission to CRO.
0-5 years of experience
Participated in patient screening and enrollment as was outlined by department guidelines and IRB protocols
- Processed and managed anti-retroviral treatment data in the clinic database system
- Generated charts using Microsoft Excel to present data in an interpretable manner
- Evaluated relationship between anti-retroviral administration, adherence and efficacy
- Contributed data to the nationwide study of anti-retroviral treatment efficacy in urban adolescent population
0-5 years of experience
Identified research participants, confirmed inclusion/exclusion criteria, read medical charts and entered data on new subjects, enrolling and consenting subjects and instructing them in protocol procedures.
- Prepared statistical information for each subject entered/removed from the research project.
- Maintained and audited medical, laboratory and research documents, assessing and documenting subjects’ response to treatment through physical assessment and/or data analysis; reported any evidence of toxicity to drugs or chemicals used in treatment of subjects.
- Developed and implemented procedures of various study designs with primary investigator and reviewed data to determine treatment modifications or alterations between the research protocol and subject care.
- Composed clinical reports and conferred with study physicians to discuss medical, statistical and health-related information concerning subjects’ medical history and treatment progress.
- Trained incoming staff on assessments, evaluation tools, protocol management and research implementation.
- Assisted with preparation of annual or terminal summary of research to the Institutional Review Board.
0-5 years of experience
The Resource Line provided general pregnancy and early childhood health information. The hotline also provided information about resources that are available to pregnant women and young children.
- Provided information about pregnancy, child health, and health and human services programs (including Child Development Services Agencies) that support pregnancy and child health to parents/ guardians and providers of health and human services
- Compiled and reported demographic and quality assurance data in monthly and annual activity reports
- Created training manual and information database for Health Communications Specialists
- Provided/documented advocacy for callers requesting conflict resolution and/or clear communication with health and human services providers
- Trained newly hired Health Communications Specialists
0-5 years of experience
Collected, transcribed and transmitted clinical data for multiple investigational drug studies in a timely matter
- Identified, evaluated and entered Adverse Events in Case Report Forms
- Coordinated and scheduled monitor visits
- Met with sponsors/monitors to review case books during startup meetings
- Provided support and information to monitors as necessary
- Identified normal lab values and certifications for study files
- Assisted in the guidance and training of less experienced staff
- Performed other duties as assigned
0-5 years of experience
Worked 10-15 hrs. /wk. while in college.
- Wrote detailed reports and follow-up instructions for clinical research focused on human subjects and their reaction to different surgical procedures including ReCell Therapy and Milliken Wound Care Dressings.
- Acquired ample exposure to subject’s recruitment and follow-up interviews.
- Managed data recording utilizing Microsoft Excel and Word.
- Assisted with digital photographic records keeping both during the surgical procedures and the follow-up appointments.
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[Clinical Research Assistant]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
