Clinical Trial Assistant Resume Sample
Alec Mills
6452 Gracie Walk,
Phoenix,
AZ
+1 (555) 281 8098
Work Experience
Temp-clinical Trial Assistant
11/2016
-
PRESENT
New York, NY
- Responsible for the shipment and tracking investigational product
- Constructs trial master file folders and is responsible for filing and maintaining up to date study documents
- Orders, prepares, packages, and sends documents and materials to clinical trial sites and vendors as needed
- Assists with the development of site tools and clinical trial start-up activities
- Provides general support to the Medical Affairs team
- Demonstrated computer skills preferably spreadsheets, word processing, database, and other applicable software programs
- Basic or Clinical research or healthcare-related experience is desired (1-2 years)
Clinical Trial Assistant, Role Will be Based
10/2010
-
08/2016
Detroit, MI
- Experience in MS Office products (e.g. Excel, Power Point & Word)
- Provide assistance in preparation, conduct and documentation of internal, external, investigator, vendor or country operations meetings: practical arrangements, presentations, minutes..
- Basic or Clinical research or healthcare-related experience is desired (0-2 years)
- Assist with periodic review of study files for accuracy and completeness
- Proficiency with Microsoft Office applications, Excel and PowerPoint
- Maintains expertise through familiarity with clinical and scientific literature and participation in professional activities
- Coordinate with sites in Spain, for order and dispatch of study materials
- Provide support to the team by updating the electronic Clinical Trial Management Systems
Clinical Trial Assistant
01/2008
-
04/2010
Chicago, IL
- Reporting - Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PM. Assesses and communicates KPIs for associated job tasks to PM with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PM
- Provide coordination and
- Creates the Trial Master File (TMF) and/or Investigator site files; supports maintenance for the duration of the study, assisting in the file review and reconciliation process in preparation for audits and archival
- Assists in the preparation, receipt, collection, tracking and review of essential documents to confirm completeness. Creates and maintains project-specific binders and related files as needed to house study records during the trial
- Receives and reviews all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference, and maintains documentation as required. Ensure that regulatory documents are updated in a timely and appropriate manner
- Assists with the translation process of study documents
- Attend clinical project team meetings and take minutes
- Provides support to imaging centers, labs, supply, and other study vendors
- Responsible for the shipment and tracking of trial materials (e.g. binders, manuals, etc.)
Education
Grand View University
2003 - 2007
Bachelor's Degree in Life Sciences
Professional Skills
- Excellent oral and written communication skills, issue management and resolutions skills as
- Excellent communication skills with the ability to prioritise
- Demonstrate problem solving and judgment skills
- Excellent organizational skills and the ability to multi-task
- Great attention to detail and excellent oral and written communication skills
- Excellent communication, presentation, interpersonal skills, both written and spoken
- Evidence of strong attention to detail and interpersonal skills
How to write Clinical Trial Assistant Resume
Clinical Trial Assistant role is responsible for interpersonal, organization, organizational, software, english, languages, microsoft, powerpoint, administrative, auditing.
To write great resume for clinical trial assistant job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Trial Assistant Resume
The section contact information is important in your clinical trial assistant resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Clinical Trial Assistant Resume
The section work experience is an essential part of your clinical trial assistant resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous clinical trial assistant responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical trial assistant position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Trial Assistant resume experience can include:
- Possesses excellent verbal, written, interpersonal skills
- Attention to detail and excellent oral and written communication skills
- Computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint
- Demonstrated effectiveness working with multiple functions in a professional manner required
- Prior experience in the medical device industry, clinical setting or research field required
- Experience with Phase 1 & 2 clinical research with preference for oncology research experience
Education on a Clinical Trial Assistant Resume
Make sure to make education a priority on your clinical trial assistant resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical trial assistant experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Clinical Trial Assistant Resume
When listing skills on your clinical trial assistant resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical clinical trial assistant skills:
- Excellent organization skills, ability to prioritize
- Solid negotiation and professional communication skills with strong oral and written English
- Effective verbal and written communication skills relating to colleagues and associates both inside and outside the organization
- Possesses good organization and planning skills
- Strong skills with Microsoft Excel required
- Good interpersonal and verbal / written skills
List of Typical Experience For a Clinical Trial Assistant Resume
1
Experience For Temp-clinical Trial Assistant Resume
- Excellent oral and written communication skills, good command of written and spoken professional English, and strong organizational abilities
- Strong interpersonal and organizational skills, ability to multitask
- Proven CTA experience in Sweden
- Demonstrated working knowledge of FDA and ICH regulations
- Experience with financial tasks such as contract and handling payments
- Demonstrated ability to deliver assignments on time
2
Experience For Stage Clinical Trial Assistant Resume
- Support company goals and objectives, policies and procedures, Good Clinical Practices, and FDA regulations
- Previous CTA experience required
- Previous experience with CTMS
- Pay rate: Determined by level of experience
- 1-2 years of experience in a clinical research/clinical trial coordinator role
- Experience with Microsoft Excel, Word, PowerPoint, Outlook, Sharepoint, Vision and Project
- Experience with Clinical Trial Management Systems is of advantage
- Experience in WORD, EXCEL, PowerPoint, other software and systems
- Prioritize multiple tasks and develop strategies for completion of all required activities
3
Experience For Clinical Trial Assistant, Role Will be Based Resume
- Proven ability to work in a team environment and with a wide variety of people
- Experience with Clinical Trial Management Systems is an advantage
- Clinical research experience (as a Study Coordinator and/or CTA)
- Understanding of FDA, ICH and GCP as well as clinical trials
- Submitting Safety Updates (SUSAR's and SAE's) to the investigators and the Central IRB
- Uploading Study documentation in to the eTMF system
- Demonstrating compliance to SOP’s
- Prepare and compile study related materials including investigator meeting binders, training manuals, Site regulatory binder, Site study binders, etc
4
Experience For Clinical Trial Assistant Supervisor Resume
- Understands the roles of the Clinical Research Associates (CRA) including familiarity regarding different types of monitoring visits as appropriate
- Supports study team in the start-up process including reviewing protocols, CRFs, preparing Informed Consent forms, develop study documents as applicable
- Tracks the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample tracking
- Assists in the development of the structure of TMF and filing system and is responsible for filing and maintaining up to date study documents
- Drafts meeting agendas and assists in preparing meeting minutes. (Interacts with other departments, as directed, to complete assigned tasks.)
- Electronic filling, archiving, keeping databases up to date
- Arrange and attend internal and external meetings, helping to produce presentation materials and generate meeting minutes
5
Experience For Clinical Trial Assistant Resume
- Coordinates ordering and tracking of trial supplies (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate
- To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate
- To assist project teams with trial progress tracking by updating the Clinical Trial Management systems
- To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)
- To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes
- Assist project managers and CRA's with developing/printing TMF binders
- Assist in the tracking and distribution of safety reports and coordinate document translations, if required
6
Experience For Temp-clinical Trial Assistant Resume
- Other administrative functions such as front office support, meeting support, etc
- Track and assist with processing site/vendor payments. Follow up on any issues as required
- Assist in assembling materials and binders for investigators' meetings
- Supports the general Clinical Development team with ongoing conduct of studies and provides general administrative support
- Assists with patient recruitment tracking activities as applicable
- Complete Process Data Collection Forms (e.g. log in, tracking and quality control) as applicable for study
- Tracks publications and maintains listing of articles on intranet
7
Experience For Stage Clinical Trial Assistant Resume
- Assists with training of junior staff as applicable
- Attends Clinical project/study meetings as applicable and generates meeting minutes
- Assists project teams with trial progress by updating Clinical Trial Management System (CTMS)
- To support the Clinical Operations teams with ongoing conduct of studies
- To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate
- To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.)
- To copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate
- To assist in the tracking and distribution of safety reports
- To attend project team meetings and generate meeting minutes
8
Experience For Clinical Trial Assistant, Role Will be Based Resume
- To assist with the coordination of team member tracking
- CTA - Assists in the management of study documentation and supplies during all phases of the protocol execution (start-up, maintenance and study closure)
- Enter and maintain current data in clinical trial management systems (i.e., document tracking, accounts and contacts)
- Maintains knowledge of regulations, guidelines, policies, and practices for conducting clinical trials. ·
- Knowledge and firm understanding of the GCP guidlines
- Follow strictly set procedures when doing the above
9
Experience For Clinical Trial Assistant Supervisor Resume
- Judgment and Problem Solving
- Be flexible and adjust to rapidly changing projects
- History of working with multiple internal and external customers
- Previous working knowledge of Word, Excel, Outlook and PowerPoint
- Exp. utilizing eTMF
- Arranges meeting logistics
- 2 yrs. exp. with Contracts working with Investigative Sites
10
Experience For Clinical Trial Assistant Resume
- Provide coordination and support to the CSMs (Clinical Study Managers) to ensure achievement of study goals and timelines
- Track and maintain study logistic information, systems and tools
- Maintain and manage appropriate study documentation in accordance with regulations and timelines
- Provide support from study start-up through study close-out
- Track and reconcile essential documents for Central Master Files according to ICH GCP and/or ISO 14155 and company procedures; ensure quality of documentation and archiving
List of Typical Skills For a Clinical Trial Assistant Resume
1
Skills For Temp-clinical Trial Assistant Resume
- Good communication skills and eager to learn
- Excellent planning, organizational and administrative skills
- Strong customer support service skills
- Professional communication skills with solid oral and written English
- Familiarity with applicable regulatory requirements, Good Documentation Practices, and Good Clinical Practices/ICH guidelines
- Experience within the Pharmaceutical/CRO industry or equivalent site experience
2
Skills For Stage Clinical Trial Assistant Resume
- Understand clinical study protocols and efficient project management skills
- Effectively follow written/oral instructions
- Utilizes technology effectively to support the clinical development process
- Good understanding of financial systems and contracting process (desirable, but not required)
- Demonstrates significant levels of independence in identifying and completing tasks
- A good understanding of the clinical trial process and required CTA activities
- Ideally 1 years experience working with Essential Documents in Clinical Trials in the pharmaceutical / CRO/ hospital environments
- Experience in medical device industry, clinical setting, or research field required
3
Skills For Clinical Trial Assistant, Role Will be Based Resume
- Demonstrated working knowledge of GCP, ICH guidelines and NMPA regulations
- Demonstrated proficiency with computer platforms and applications
- Experience in a clinical trial assistant role
- Experience in clinical research area
- Demonstrated competency in the utilization of Microsoft tools, specifically Word; Excel; PowerPoint; and Project
- Relevant experience in pharmaceutical industry or CRO
- Experience in related are competencies
- Pay Rate: Determined by experience
4
Skills For Clinical Trial Assistant Supervisor Resume
- Significant technical expertise and learning ability with demonstrated flexibility required to maintain pace with best practices in the industry
- Experience with Microsoft Excel, Word, PowerPoint, Outlook, SharePoint, Visio and Project
- Administration background with at least two years of experience in support of clinical research with preference to oncology research
- Trial Master File experience
- Good knowledge on ICH – GCP guidelines
5
Skills For Clinical Trial Assistant Resume
- Demonstrates knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
- Excellent knowledge of English, any other language is an asset
- Clinical research or health care related academic or work experience preferable
- Forecasts, tracks and reports milestones, as well as verifies completeness of the study milestones prior to invoice payment
- Distributing, collecting, reviewing, tracking and archiving documents, agreements and training documentation
6
Skills For Temp-clinical Trial Assistant Resume
- Providing guidance and direction to other CTAs, developing associated training materials and training teams on how to use processes and tools
- Producing, distributing, and tracking safety mailings (including IND safety report notifications) with internal and external stakeholders
- Receiving, reviewing, categorizing, and filing essential documents into the TMF
- Preparing meeting agendas and minutes, and archiving agendas and minutes in the clinical trial master file (TMF) as appropriate
- Compiling, printing and distributing clinical data for review and reconciliation by cross-functional study team members
- Serving as a super-user for the CTMS and TMF systems and working with Clinical Operations leadership to establish workflows for document processing
- Preparing, updating, follow-up of paper & electronic filing of clinical trial related documents
7
Skills For Stage Clinical Trial Assistant Resume
- Attending team meetings, writing meeting minutes and/or reports
- Entering, updating and tracking of records in the Clinical Trial Management System
- Tracking of ICH/GCP and/or FDA 21 CFR essential study documents using the applicable tracking tools
- Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools
- Identifying and resolving gaps in processes or procedures
- Scheduling and managing meetings on behalf of Clinical Study Managers and other Clinical Operations staff
- Designing and assembling startup document packets, site reference binders, study worksheets, newsletters and similar materials
- Generating communications to field based CRAs on new or revised administrative procedures and ensuring associated processes are followed
- Entering and auditing investigator, investigative site, and vendor and/or contractor information into the Clinical Trial Management system (CTMS)
8
Skills For Clinical Trial Assistant, Role Will be Based Resume
- Creating and maintaining a master list of study documents and significant communications for assigned study(ies)
- Maintaining a positive, motivated and conscientious behavior in a highly demanding work environment
- Arranging, attending (when required) and follow-up of meetings, i.e. investigator meetings, general meetings
- Handling of study supplies (incl. shipments, tracking, ...)
- Performing regulatory document review and approval, including site specific Informed Consents
- Multitasking, ability to work in multiple projects in parallel
- Communicating with internal and external study team members and vendors
- Maintaining Clinical Operations and study team calendars
9
Skills For Clinical Trial Assistant Supervisor Resume
- Determining the TMF structure and content
- Coding of documentation in Trial Interactive
- Preparing of study binders for in-house and site use
- Assisting in the preparation/submission of submission packages to the Ethics Committees/Institutional Review Board
- Writing letters, faxes, emails and telephone reports; reviews, uploads and updates eTMF system as needed
- Submitting Safety Updates (SUSAR’s and SAE’s) to the investigators and the Central IRB
10
Skills For Clinical Trial Assistant Resume
- Ensuring trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements
- Maintaining site level protocol information in Trial Management Systems (e.g. CTMS)
- Working knowledge of MS Word, PowerPoint, Outlook, and Excel
- To assist with the coordination of various tracking reports, including but not limited to, team member tracking and training
- Proactively identifying department tracking needs and the appropriate systems (existing or new) for tracking
- Provide day-to-day departmental/project support activities, such as managing study supply inventory and orders, shipping, filing, faxing, etc.
List of Typical Responsibilities For a Clinical Trial Assistant Resume
1
Responsibilities For Temp-clinical Trial Assistant Resume
- Collecting, processing and archiving study related documents as appropriate
- Contributing and participating in global CTA team meetings
- Arranging international travel
- Attending to other non-TMF as-hoc administrative support tasks
- Keep database, tracking systems and tools up to date in order to support budget payment and contracting processes
2
Responsibilities For Stage Clinical Trial Assistant Resume
- As representing AstraZeneca for the customers, follow business etiquette and dress-code according to AstraZeneca image and obligations
- Assist project managers and CRA’s with developing/printing TMF binders
- Familiarity with sample management, sample processing, and biobanking best practices
- To assist study manager with trial progress tracking by updating IMPACT (CTMS)
- Assist senior team members with in the planning, preparation, and on-site support of investigators meetings
- Provide support to the project teams by updating the Clinical Trial Management Systems
- Contact study personnel at sites regarding (administrative) issues
- Additional country-specific tasks depending on country need
- Work closely with other members of the Clinical Team to support activities during a study startup, study execution and close out phases
3
Responsibilities For Clinical Trial Assistant, Role Will be Based Resume
- Conduct periodic review and tracking of all clinical trial deliverables and all applicable metrics
- Maintains knowledge of regulations, guidelines, policies and practices for conducting of clinical trials
- Perform all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions
- Exp. utilizing TMF
- Develop and maintain working relationships with database vendors, study teams, and site investigators
- Organize and coordinate the logistics of internal and external meetings such as Advisory Board meetings and Investigator meetings
- Assist in preparation of audits and inspections
- Work within established SOPs; identify and under direct supervision, suggest process improvements
- Administrative responsibilities also include maintenance of department organizational charts, maintenance of job descriptions, ordering supplies, filling documents, shipping study binders/supplies, shipping investigational product for clinical studies, completing/submitting expense reports
4
Responsibilities For Clinical Trial Assistant Supervisor Resume
- Prepare, handle, distribute, file, and archive clinical documentation and reports
- Prepare and distribute agendas for team meetings
- Attend team meetings and record and produce minutes for those meetings
- Maintain team contact lists per projects
- Provide (cross functional) clerical and administrative support to project team(s)
- Prepare and manage Trial Master Files per standard guidelines
- Perform administrative tasks to support team members with clinical trial execution
5
Responsibilities For Clinical Trial Assistant Resume
- Supports the Clinical Trial Management/operational study teams in the execution and delivery of studies
- Support study feasibility activities and perform database/web searches for sites as needed. Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation
- Reconcile and transmit all essential documentation to CDIC as per Forest policy
- Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems
- Generate reports in various applications to assist the Clinical Trial Managers to perform clinical data review
6
Responsibilities For Temp-clinical Trial Assistant Resume
- Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues
- Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies)
- Support clinical team with requests from management as needed
- Manage and coordinate travel requirements for group, consultants, and partners
- Function as a back up to general Clinical Trial Manager activities as needed
- Coordinate and provide minutes for department/project meetings or conference calls
- Conduct quality review of documents
7
Responsibilities For Stage Clinical Trial Assistant Resume
- Maintain databases/spreadsheets and compile reports; and
- Set-up and maintain project files and investigator files
- Fax, photocopy, and distribute study-related documents
- Order and distribute office and study related supplies needed by project team
- Generate, maintain and distribute study-specific reports (e.g. patient enrollment, regulatory documents, site visits, investigator payments)
8
Responsibilities For Clinical Trial Assistant, Role Will be Based Resume
- Ship/ mail supplies and documents to clients, investigator sites, and Institutional Review Boards (IRB)
- Prepare regulatory binders (Study File Notebooks) for study sites
- Maintain investigator payment documentation
- When allocated by study management, collection and preparation of essential/ required documents for submission to a central IRB or a country's central Ethics Committee, and if necessary based on local requirements the Competent Authority
- Set up, maintain and review regulatory and administrative documents for the Trial Master File (TMF)
- Ready To travel if required
- Assists the Clinical Operations team in completion of all required tasks to meet departmental and project/study goals
- Demonstrates familiarity with ICH Good Clinical Practice (GCP), appropriate regulations, relevant Lung Biotechnology Inc. SOP’s and Lung Biotechnology Inc. internal tracking system
- Sets up files related to a variety of clinical trials (i.e. Site Files and Trial Master Files (TMF))
9
Responsibilities For Clinical Trial Assistant Supervisor Resume
- Maintains TMF / Regulatory Files in accordance with GCP, performs periodic quality control checks of the study files for accuracy and completeness, final reconciliation and archival
- Prepares, handles, distributes and files clinical documentation and reports (paper and electronic)
- Assists with internal/external audit preparation of files
- Assists with communication between clinical sites, CRAs and CROs as applicable
- Takes ownership of CTA tasks
- Assists study team with clinical study (ies) administration tasks and sites for adherence to protocol, GCP and company SOPs
- Tracks timely enrollment against plan
- Assists with guidance from study lead, clinical trial insurance to support study start up
10
Responsibilities For Clinical Trial Assistant Resume
- Prepares, requests, and tracks Purchase Orders for contracted services across the clinical study(ies)
- Assists with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings
- To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s)
- To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals
- To assist project teams with study specific documentation and guidelines as appropriate
- To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival
- To process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study
- To assist in co-ordination of Investigator payments, if applicable
- To co-ordinate document translation, if required
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