Senior / Clinical Research Associate Resume Samples

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J Cormier

Jessie

Cormier

217 Roob Fall

Detroit

+1 (555) 586 6692

217 Roob Fall

Detroit

Phone

p +1 (555) 586 6692

Experience Experience

Chicago, IL

Senior.clinical Research Associate

Chicago, IL

Kuhn, Cole and Pacocha

Chicago, IL

Senior.clinical Research Associate

Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work
In country based, may provide administrative management oversight to up to 8 Study Leads responsible for conduct of study at local level
Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested by Clinical Trial Manager
Informs the Clinical Operations Manager and/or the Senior Clinical Operations Manager of any variance
Provides coaching, counseling, and feedback, and identifies developmental opportunities for assigned staff
Track and manage performance metrics for assigned monitoring staff
Assists in resolving any issues in order to ensure compliance with site file audits in conjunction with ISSC

Los Angeles, CA

UK Senior Clinical Research Associate

Los Angeles, CA

Sauer, Klocko and Bechtelar

Los Angeles, CA

UK Senior Clinical Research Associate

Develop new improved processes and perform implementation
Provide field training and guidance to new Clinical Specialists
Assist and conduct Clinical Monitoring activities
Data review, safety reporting and complaint handling
Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation
Document procedural case observations for insights in investigating post procedural events
Ensures Audit readiness for internal, external and site Audits

present

Detroit, MI

Senior Clinical Research Associate, Oncology

Detroit, MI

Rippin-Raynor

present

Detroit, MI

Senior Clinical Research Associate, Oncology

present

Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA
Manage specific study responsibilities as assigned by Sr. Manager or Clinical Operations Director/Sr. Director
Assist with management of third party vendors
Assist in the development, assembly and distribution of study documents, manuals and tools
Assist the study management in identifying and generating changes in scope
Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
Establishing regular lines of communication plus administering protocol and related study training to assigned sites

Education Education

Bachelor’s Degree

University of San Francisco

Bachelor’s Degree

Skills Skills

Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
Excellent understanding and demonstrated application of GCPs and applicable SOPs
Strong attention to detail
Excellent English and Spanish skills
Willingness and ability to travel
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Strong customer focus
Proven flexibility and adaptability
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Development and preparation of the local informed consent form

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15 Senior / Clinical Research Associate resume templates

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Senior Clinical Research Associate, R&D Resume Examples & Samples

Set up the GCP infrastructure necessary to conduct simple in-house clinical studies such as method comparison and precision
Write and maintain necessary SOPs, study binders and personnel training records that are required to be in compliance with GCP
Help develop and implement specifications, SOPs and plans for electronic data capture, data management and statistical analysis of clinical data that meet GCP and project requirements
Work with external vendor and project team to configure, test and implement eDC system as per specifications
Help qualify, initiate and audit external CROs conducting clinical studies to ensure they meet GCP and company requirements
Help monitor ongoing clinical studies including monitoring data collection, patient sample usage and testing supplies usage
Work with partners to resolve issues and escalate to management issues that can impact study timing and quality
Help develop and execute procedures to close clinical studies and reconcile clinical samples, supplies and data
B.S. in Biology, Medical Technology, Clinical Laboratory Science, Chemistry, Biochemistry, Biotechnology or related scientific or engineering discipline
A minimum of 5 years experience in Clinical Affairs preferably in the In-Vitro Diagnostics (IVD) medical device industry
Thorough understanding of FDA, ICH and GCP regulations, requirements and guidance for IVD device validation and clinical studies in support of 510k applications including clinical data management, electronic data capture (eDC) and clinical site initiation, monitoring and closing
Strong written and verbal communication skills and ability to work effectively across functions and sites
Ability to work independently and build organizational capabilities and processes from the ground up
This position does not offer Relocation Assistance

Senior / Clinical Research Associate Resume Examples & Samples

Solid regulatory and ethics knowledge of Israel
Valid passport
Experience as a Clinical Research Associate / monitor or in a health sciences field / clinical research setting is preferred

Senior / Clinical Research Associate Portugal Resume Examples & Samples

In depth knowledgee of ICH-GCP, EU and FDA requirements
Experience of clinical trials in Portugal
Experience in Oncology (preferably Melanoma or lung)
Excellent English and Portuguese skills
Previous xperience in the CRO industry would be advantageous

Senior / Clinical Research Associate, Ukraine Resume Examples & Samples

You will perform and coordinate all aspects of the clinical monitoring process from "start up" to "close out"
You should thrive in multi-national project teams and be focused on delivering exemplary levels of customer service
Degree in medical science, pharmacy, life science or related field

Senior Clinical Research Associate Based Resume Examples & Samples

Several years of monitoring experience
Excellent English
Willingness & ability to travel
Flexibility and ability to work on multiple projects and to support tasks such as feasibilities, site contracts and budgets, submission documentation and contribute to regulatory country intelligence as required
Experience of starting up clinical studies or contributing to start up tasks

Senior / Clinical Research Associate Resume Examples & Samples

A minimum of 2 years on site monitoring experience
Experience of clinical trials in Spain
Excellent English and Spanish skills
LI-EC1

Senior Clinical Research Associate CPS Resume Examples & Samples

Function as a mentor and role model for other CRA team members
Provide study specific training for CRAs acting as a lead CRA on individual projects
Establish site recruitment plan in collaboration with site during qualification visit; follow-up and update at initiation visit and monitoring visit
Attend external client meetings and presentations including investigator meetings and professional conferences

Senior Clinical Research Associate Permanent Resume Examples & Samples

Conducting feasibility
Set up of our Insourced Clinical Trials. Includes HRA/Ethics submissions, budget negotiations and creation of monitoring tools
Perform all types of site visits including qualification visits, initiation visits, monitoring visits, motivational visits and close out visits to ensure patient safety and data integrity
Train and assist investigative sites
May assist/take on monitoring lead activities for a Global study as needed
Identify/evaluate potential investigators for future Celgene studies
Establishing/maintaining a local partnership with our Partner CROs

Senior / Clinical Research Associate Resume Examples & Samples

Oversees the progress of a Clinical Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements
Administer protocol and related study training to assigned site
Establish regular lines of communication with sites to manage ongoing project expectations and issues

Senior / Clinical Research Associate Resume Examples & Samples

A minimum of 24 months on site monitoring experience
In depth knowledge of ICH-GCP and FDA requirements
Experience of clinical trials
Willingness and ability to travel across Africa
Excellent Portuguese and English language skills

Senior.clinical Research Associate Resume Examples & Samples

Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically
Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested by Clinical Trial Manager
Works with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtains and reviews regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
Serves as mentor for more junior CRAs as well as new CRAs to the project
May conduct field training and assessment of CRA Is and CRA IIs
Strong knowledge of clinical research process and medical terminology
Ability to handle several priorities within multiple, complex clinical trials
Willingness and ability to travel domestically and internationally, as required

Senior Clinical Research Associate Quebec & Eastern Territory Resume Examples & Samples

Investigative Site Monitoring -Demonstrate a commitment to quality in all aspects of monitoring; adhere to study monitoring plans; conduct Pre-study Visits at Investigative Sites; conduct Study Initiation Visits at Investigative Sites; conduct Interim Monitoring Visits at Investigative Sites; review investigator study files and reconcile versus trial master files; perform investigational product accountability; conduct Close-out Visits at Investigative Sites
Train and Assist Investigative Sites- Attend Investigator Meetings; train investigative site personnel in GCP and ensure sites are conducting Celgene clinical research according to the protocol, local regulatory requirements, and other appropriate regulations; serve as the liaison between Celgene and assigned sites; build relationships with site staff at assigned sites
Communication- Identify site issues, ensure proper escalation, if necessary, and ensure resolution; create trip reports, confirmation/follow-up correspondence and telephone contacts for assigned sites; respond to audit findings; adhere to proper lines of communication within Celgene; attend and participate in study team meetings; keep information in the CTMS current; maintain calendar
Development -Maintain up-to-date medical and clinical knowledge for assigned therapeutic areas; mentor/coach new CRAs; maintain annual training records
Significant knowledge of Clinical Development Process
Knowledge of regulatory environment and guidelines (ICH, GCP and CFR)
Excellent relationship-building skills
Bilingual in English and French a requirement
LI-TS1
LI-PRIORITY

Senior Clinical Research Associate, Virology Resume Examples & Samples

Relevant experience in multi-therapeutic indications as they relate to the conduct of clinical trials
Experience within AbbVie Clinical Operations department by working on global clinical studies in an affiliate is a definite key asset
Experience monitoring virology studies is desired

Senior Clinical Research Associate UBC Resume Examples & Samples

Monitors clinical trials to ensure investigator and sponsor responsibilities are compliant with regulatory requirements
Attends project team meetings, department meetings and minimum of monthly 1:1 with manager; responsible for content of these meetings
Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections
Ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol
Monitors within EDC data entry, if applicable, and assists sites with DCF resolution
Maintains regular contact with assigned sites per study requirements
Consistently submits expense reports within UBC timelines; consistently follows UBC Travel Guidelines
Consistently completes sponsor specific training and documentation within requested timelines
Instruct how to conduct visit, report/letter writing and manage issues and actions
Bachelor’s degree – Life Science preferred or equivalent years of industry and monitoring experience
Thorough knowledge of medical terminology
Consistently meets or exceeds metrics for quality trip reports and letters
Consistently meets or exceeds metrics for completion of UBC and/or sponsor training with appropriate documentation
Thorough knowledge of ICH, GCP, CFR and UBC SOPs

Temporary Senior Clinical Research Associate Resume Examples & Samples

Associates Degree within healthcare or life science discipline or licensed professional (e.g, RN) required; Bachelor’s degree preferred
Minimum 3 years prior experience as CTA or comparable work experience in the field of research/development in an administrative capacity required; Field CRA experience, certification as a CCRA/CCRC/CCRP, or completion of a recognized clinical research certificate/training program is a plus
A demonstrated understanding of ICH-GCP, including the ability to recognize deficiency and recommend corrective actions
Basic understanding of medical terminology
Proficiency with Microsoft Outlook, Excel, Word and PowerPoint is required; proficiency with clinical software systems (e.g., CTMS, IXRS, EDC) is a plus
Effective communication skills with the ability to vary writing style to connect with different audiences
Basic math skills along with the ability to compute rate, ratio, and percent
Ability and desire to work in a team environment
Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment

Senior.clinical Research Associate Resume Examples & Samples

Train site staff on the EDC system and verify site computer system
Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in Novella SOPs by using approved Novella/sponsor templates and reports
Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries
May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM
May serve as primary contact between Novella and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested
Ensure all study deliverables are completed per Novella and study timelines
Perform other duties, as requested
Four+ years of oncology experience and/or medical device
Understand electronic data capture including basic data processing functions

UK Senior Clinical Research Associate Resume Examples & Samples

Support implementation of assigned clinical research projects in Europe related to specific products/topics according to internal and external regional requirements, including acquisition of human use approval from Ethics Committees, case report form review, data collection, site monitoring and auditing. Maintains close contact with clinical study site coordinators and physicians who are clinical investigators
Supervises, leads and motivates study sites
Ensures Audit readiness for internal, external and site Audits
Develop new improved processes and perform implementation
Provide field training and guidance to new Clinical Specialists
Reporting site enrollment progress including device accountability and enrollment deviations (inclusion/exclusion criteria, sequential enrollment)
Assist and conduct Clinical Monitoring activities
Or equivalent in related field
5 years of
Of previous related medical
Device and/or clinical
Experience or
Clinician experience in intraoperative
Procedures acquired
From Registered Nursing
Degree curriculum (RN), or in
Positions such as Radiologic
Technologist (RT), Operating
Room Technician (ORT), or
Cardiovascular Technician
(RCIS) or
Experience in interventional
Cardiology or cardiothoracic
Surgery
Strong written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
Full knowledge and understanding of cardiovascular science
Full understanding of cardiovascular anatomy, pathology and physiology
Full understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

Senior Clinical Research Associate, Oncology Resume Examples & Samples

Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required
Ensure internal and study-related trainings are completed per Novella and/or study timelines; CTMS should be current at all times with the pertinent site updates/contacts
May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs
Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA
Able to mentor other CRAs and co-monitor, as required
Ability to travel domestically and internationally

Senior Clinical Research Associate, Oncology Resume Examples & Samples

Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready
Minimum of 4 years of direct site management (monitoring) experience in a Biopharmaceutical, Pharmaceutical or CRO company
Experience monitoring Oncology clinical studies
Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
Demonstrated ability to mentor/lead
Proven Skills in Site Management including independent management of site performance and patient recruitment
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
Demonstrates commitment to Customer focus
Works with high quality and compliance mindset

Senior Clinical Research Associate Level Resume Examples & Samples

Understanding of ICH-GCP, EU and FDA requirements
Fluency in English and in Russian
Proven clinical monitoring skills

Senior.clinical Research Associate Resume Examples & Samples

Provides leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management & Monitoring personnel in charge of implementing and monitoring clinical studies conducted within country (ex-US)/ region (US) of responsibility
In country based, may provide administrative management oversight to up to 8 Study Leads responsible for conduct of study at local level
Accounts for complexity of site and study issues
Trains assigned personnel in monitoring techniques and study-specific requirements also through accompanied on site visits. Functions assigned staff as a resource for monitoring-related questions and gives appropriate guidance
Responsible for reporting within company systems of Site Management & Monitoring headcounts/resources/workload planning and actuals in country(ies)/region(s) responsible for
Trains personnel in monitoring techniques and study specific requirements also through accompanied on site visits. Functions as a resource for monitoring-related questions and gives appropriate guidance. Trains personnel on country specific regulation/processes/procedures (ex-US)
Advises on pre-audit activities for both PV and GCP requirements
Supports the Clinical Operations Manager and/or Senior Clinical Operations Manager in the development and implementation of site management initiatives to maintain enrollment and recruitment timelines
Reviews monitoring visit reports for assigned SCRAs
Endures corrective action is implemented at the clinical site if appropriate
Where appropriate, monitors project progress against time frame and budget
Informs the Clinical Operations Manager and/or the Senior Clinical Operations Manager of any variance
Proven strong site management and monitoring skills in Neurology
Strong planning and organizations skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Demonstrated ability to manage multiple priorities/projects
Excellent communication and interpersonal skills, including situations of conflict resolution, problem solving and crisis management
Demonstrated proactive and positive team player
Exhibits high level of flexibility when facing changes in the work environment
Working knowledge and experience in AbbVie systems (electronic data capture systems and clinical trials management systems) and procedures are desirable

Senior Clinical Research Associate Ontario Territory Resume Examples & Samples

Data Integrity -Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with study team in order to improve data quality; ensure issues of data quality are escalated and resolved with study team and CQA
Subject Safety- Perform safety reviews/SAE reconciliations; monitor the informed consent process; ensure investigative sites’ adherence to GCP, ICH guidelines, and local regulations
Corporate Goals- Identify/evaluate potential investigators for future Celgene studies; build effective and positive relationships with Principal Investigators; ensure timely submission and review of CRF data and query resolution according to timelines set forth in the SMP; schedule travel following Celgene’s travel policy, and submit expense reports in an accurate and timely manner
Regulatory Documentation -Prepare ethics submissions and local regulatory documents at the country level, as needed; maintain local document files at a country level, as needed; review translations for ICD and other study documents, as needed; oversee to assure SOPs are followed in obtaining translations on necessary study documents
Monitoring Lead (As assigned)- Serve on study team as monitoring representative; review RFPs regarding monitoring specifications; develop the study monitoring plan and subsequent revisions; review, track and acknowledge monitoring visit reports; manage and track monitoring site visits to ensure quality monitoring; ensure adequate monitoring resources; ensure monitors are trained properly in the study requirements; track and report critical issues to study team; participate in CRF and protocol review process; attend, participate and present at Investigator Meetings; perform field assessments of Celgene and CRO FMs, as required; develop study-specific tools for Investigative sites and Field Monitors; conduct FM meetings; oversee CRO monitoring, as required
Expert in a number of diseases, treatments, and compounds
Experience with developing study monitor plans
Significant site management skills
Excellent written and oral communication skills, including presentations
Proficient in writing function SOPS / Work Practices Demonstrated problem-solving skills
Ability to resolve routine issues effectively and independently
Organizational and time management skills

Senior.clinical Research Associate Resume Examples & Samples

Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies
Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation
Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work

Senior Clinical Research Associate Western Resume Examples & Samples

Investigative Site Monitoring - Demonstrate a commitment to quality in all aspects of monitoring; adhere to study monitoring plans; conduct Pre-study Visits at Investigative Sites; conduct Study Initiation Visits at Investigative Sites; conduct Interim Monitoring Visits at Investigative Sites; review investigator study files and reconcile versus trial master files; perform investigational product accountability; conduct Close-out Visits at Investigative Sites
Data Integrity - Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with study team in order to improve data quality; ensure issues of data quality are escalated and resolved with study team and CQA
Subject Safety - Perform safety reviews/SAE reconciliations; monitor the informed consent process; ensure investigative sites’ adherence to GCP, ICH guidelines, and local regulations
Train and Assist Investigative Sites - Attend Investigator Meetings; train investigative site personnel in GCP and ensure sites are conducting Celgene clinical research according to the protocol, local regulatory requirements, and other appropriate regulations; serve as the liaison between Celgene and assigned sites; build relationships with site staff at assigned sites
Communication - Identify site issues, ensure proper escalation, if necessary, and ensure resolution; create trip reports, confirmation/follow-up correspondence and telephone contacts for assigned sites; respond to audit findings; adhere to proper lines of communication within Celgene; attend and participate in study team meetings; keep information in the CTMS current; maintain calendar
Development - Maintain up-to-date medical and clinical knowledge for assigned therapeutic areas; mentor/coach new CRAs; maintain annual training records
Corporate Goals - Identify/evaluate potential investigators for future Celgene studies; build effective and positive relationships with Principal Investigators; ensure timely submission and review of CRF data and query resolution according to timelines set forth in the SMP; schedule travel following Celgene’s travel policy, and submit expense reports in an accurate and timely manner
Regulatory Documentation - Prepare ethics submissions and local regulatory documents at the country level, as needed; maintain local document files at a country level, as needed; review translations for ICD and other study documents, as needed; oversee to assure SOPs are followed in obtaining translations on necessary study documents
Monitoring Lead (As assigned) - Serve on study team as monitoring representative; review RFPs regarding monitoring specifications; develop the study monitoring plan and subsequent revisions; review, track and acknowledge monitoring visit reports; manage and track monitoring site visits to ensure quality monitoring; ensure adequate monitoring resources; ensure monitors are trained properly in the study requirements; track and report critical issues to study team; participate in CRF and protocol review process; attend, participate and present at Investigator Meetings; perform field assessments of Celgene and CRO FMs, as required; develop study-specific tools for Investigative sites and Field Monitors; conduct FM meetings; oversee CRO monitoring, as required
Significant medical and scientific knowledge
Significant knowledge of monitoring
Significant knowledge of medical terminology
Experience preparing for and presenting at investigator meetings
Ability to comprehend protocols and supportive information
Ability to work in a cross-functional team environment
Significant knowledge of Esystems (Inform, CTMS, etc)
Ability to travel extensively within Canada including overnight stays (approximately 50%)
Ability to drive an automobile and have a valid driver’s license

Senior Clinical Research Associate, Oncology Resume Examples & Samples

Manage specific study responsibilities as assigned by Sr. Manager or Clinical Operations Director/Sr. Director
Ensure Investigational Product (IP) needs for clinical studies are available and managed appropriately
The candidate must have a good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S.; international regulations and guidelines, is preferred, but not required
Excellent oral and written communication, organizational and planning skills are required, ideally with the ability to manage budgets

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