Clinical Trial Associate Resume Sample
Nathen Gottlieb
5227 Greenfelder Springs,
Dallas,
TX
+1 (555) 729 8875
Work Experience
Clinical Trial Associate
07/2016
-
PRESENT
Phoenix, AZ
- Develop and track a variety of diverse project budgets and identify key performance indicators,in a fast-paced, changing environment
- Assist when required with the Ethics / Regulatory Submissions
- Assisting the CSLs in preparing Protocols, Investigator Brochures and documents which includes keeping track of revisions
- Support the CSL in the Set up and maintenance of the Central Master Files (CMF) and Electronic filing systems/ set up of the Investigator Master File (IMF) compliant to regulations and in audit ready state
- With support from CSL,CRA manage and maintain study documents & trial supplies e.g. Delegation logs, CVs, test site protocols , monitoring plans, binders etc
- Assisting the CSL in the preparation of essential clinical trial documentation, distributing, tracking and filing of documents on return
- Ensure that any tracking tools are set up and maintained throughout the trial
- Support CA function during audits e.g BIMO, Pharma partner, FDA
- Assist with collating, tracking & shipping of documentation
Senior Clinical Trial Associate
11/2011
-
03/2016
Phoenix, AZ
- General study filing
- Ensures understanding of clinical trial protocols and site specifications and the scientific/medical objectives of the clinical trials
- Participate in the review and approval of clinical monitoring visit reports in conjunction with the Clinical Trial Manager and ensure that all outstanding follow up items are closed out in a timely manner
- Develop study specific tools for tracking and reporting for Clinical Operations team
- Participate in the review and finalization of study plans and circulate for review and approval
- Participate in site selection and start-up process
- Ensures patient enrollment activities are within protocol guidelines
- Day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to Project Manager or senior Clinical Operations staff
Lead Clinical Trial Associate
05/2005
-
07/2011
San Francisco, CA
- Performs QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for studies
- Fully understands the need for and importance of being inspection ready and diligently follows Clinical Operations SOPs; identifies and communicates if there are gaps
- Accountable for ensuring that agendas for meetings are clear and distributed in advance; takes comprehensive and precise minutes for internal and external meetings. Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking
- Assists with planning of Investigator Meetings
- Provides study level information to enable accurate and efficient supply of clinical product to the sites
- Adheres to Clinical Operations processes and SOPs
- Communicates and coordinates with senior Clinical Operations staff/management to ensure accurate and comprehensive completion of documents; makes sure that completed documents are provided within the requested timeframes and ahead of submission deadlines
- Under the guidance and direction of the Clinical Study Manager, or designee, interfaces with other functions to coordinate relevant and timely exchange of information / materials to support clinical trials delivery within the drug development process
- Ensures patient enrollment activities are conducted in a timely manner
Education
Grand View University
2000 - 2005
Bachelor's Degree in Life Sciences
Professional Skills
- Demonstrated organizational skills and interper-sonal skills
- Team player and ability to build relationships / Strong organizational skills
- Detail oriented, highly organized, excellent follow up skills, and results oriented
- Excellent computer skills (Microsoft Office Word, Excel, Outlook)
- Experience as CTA (or comparable operating experience) in pharmaceutical or CRO required
- Demonstrated experience performing clinical trial activities in a biotech/pharmaceutical/ CRO company or related healthcare company
- Prior data review/remote monitoring experience
How to write Clinical Trial Associate Resume
Clinical Trial Associate role is responsible for computer, microsoft, interpersonal, english, organizational, databases, acute, research, training, organization.
To write great resume for clinical trial associate job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Trial Associate Resume
The section contact information is important in your clinical trial associate 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 Associate Resume
The section work experience is an essential part of your clinical trial associate 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 associate 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 associate position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Trial Associate resume experience can include:
- Self motivated, detail-oriented, ability to handle multiple tasks efficiently and effectively, and excellent organizational skills required
- Excellent verbal and written skills and have the ability to deal effectively with all levels of management
- Other requirements include a strong attention to detail, strong Microsoft Office skills, and the ability to adapt to various client requirements
- Demonstrated strong proficiency with MS Office
- Relevant experience of CRA monitoring experience
- Prioritize, multi-task and demonstrate flexibility and attention to detail
Education on a Clinical Trial Associate Resume
Make sure to make education a priority on your clinical trial associate 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 associate 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 Associate Resume
When listing skills on your clinical trial associate 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 associate skills:
- Good understanding of good clinical practices and/or good manufacturing practices
- Good interpersonal skills, ability to successfullyinteract with a wide range of people
- Develops and maintains effective working relationships and demonstrates cross-cultural sensitivity when working with others
- Sound analytical and problem solving skills; ability to act with a consistent sense of urgency and acute attention to detail
- Develop and maintain effective working relationships and demonstrates cross-cultural sensitivity when working with others
- Computer skills - MS office suite CTMS (TW, Celtrak), Knowledge of databases
List of Typical Experience For a Clinical Trial Associate Resume
1
Experience For Senior Clinical Trial Associate Resume
- Min 3 years experience as CTA (or comparable operating experience) in pharmaceutical, CRO, or healthcare environment(s) required
- Computer skills including MS office suite, CTMS (TW, Celtrak) and knowledge of databases
- Demonstrate experience in working in electronic document management systems
- On-going clinical trials experience
- Solid grasp of MS Powerpoint, Word, Excel and Project
2
Experience For Intern, Clinical Trial Associate Resume
- Experience in Clinical Trials or Clinical Project management
- Experience with Investigator Sponsored Trials
- Works with CRO to collect and review essential regulatory documents prior to site initiation/study drug release
- Two years' experience in working with Trial Master Files
- The CTOM ensures trial(s) are managed to the highest quality to strive for safety and effectiveness of products
3
Experience For Lead Clinical Trial Associate Resume
- Demonstrated ability to to efficiently work with other CTOMs in the same study
- Creating and or reviewing study plans, specification documents, materials and tools
- Performing QC of TMF as appropriate
- Understanding / familiarity with drug development and process and Pharma
- Understanding / familiarity with drug development and process and Pharma industry
4
Experience For Clinical Trial Associate, Outsourcing Resume
- Capturing the firm demand from CSC project managers
- Interacting with product suppliers (internal/external) to refine targeted product, quantity and delivery time
- Efficient at meeting planning / generating minutes
- Able to multi-task during the review/processing and preparation of essential regulatory documentation
- Execute meeting logistics (e.g., meeting minutes, expense reports, and travel coordination)
- System support and troubleshooting, including management of change and deletion requests
- Track and ensure training of study team. QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines
5
Experience For Clinical Trial Associate Resume
- Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors
- Assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations
- Receipt, review, and filing of documents submitted for the TMF
- Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings
- Support the Regional Site Managers by providing study related information and supplies, as requested
- Contribute to process improvement efforts including task forces and committees
6
Experience For Senior Clinical Trial Associate Resume
- Manage calendars and appointments. Resolve scheduling conflicts as needed
- Responsible for providing operation support into the CSR
- Participate in and contribute to Clinical Research meetings, study related meetings, training activities and crossfunctional
- Assist with study coordination activities, including
- Lead the study team and being able to efficiently work with other CTOM's in the same study
- Familiarity with medical terminology, general understanding of the R&D process and previous exposure to GCPs/ICH is required
7
Experience For Intern, Clinical Trial Associate Resume
- Assists team members with travel accommodations, scheduling and expense reports
- Generate, finalize and distribute study team agendas and meeting minutes
- Assists in finalizing eTMF Plans and Content Lists for all studies
- Assists in or is directly responsible for eTMF set-up, including study-specific and binder creation
- Manages Clinical File Room, ensuring all documentation is logged and stored appropriately
- Maintain tracking tools and spreadsheets of required investigative site essential documents and contact information
- Maintain and coordinate generation of clinical trial status reports and tracking spreadsheets and/or databases
- Generates and reviews management reports from internal tracking systems at requested intervals
- Regular mailings to site e.g. IBs/safety information, relabeling, newsletters
8
Experience For Lead Clinical Trial Associate Resume
- Support group or team in preparing study documents
- Oversee the work of Clinical Assistants and provide on-the-job training
- Responsible for coordination, tracking, and management of logistics in support of clinical trials
- Participates in user acceptance testing (UAT) for EDC/IWRS
- Assists and supports CTM and clinical operations team in presentations of clinical information concerning specific projects
- Provide systems support for the eTMF system, Veeva's Vault to users, including
- Systems training and account administration
9
Experience For Clinical Trial Associate, Outsourcing Resume
- Identify and develop templates, tools and processes for eTMF based on training needs and process gaps
- Assist CTM/CPM in tracking study related activities
- Agenda distribution & minute taking for internal study team meetings (i.e. review committees)
- Maintain knowledge of internal systems (e.g. PO creation, contract tracking)
- Assist with generating the CSR appendices and participate in SOP and WP development
- Track study progress in CTMS including patient enrollment and patient status, Oversight of Regulatory documents for site initiation
- Provide access to systems when applicable. Track and ensure training of study team
10
Experience For Clinical Trial Associate Resume
- QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines
- Travel: potential travel of up to 20%
- Coordination of timely resolution of document issues with the documents Authoritative Sources including Clinical Research Sites, Data Management Centers, Sponsors and other trial collaborators
- Generation of Certified Copies when applicable
- Creation and maintenance of a document inventory
- Generation of Metrics Reports to assist sponsors with trial oversight and demonstrates quality, completeness of the TMF as well as timely submission of TMF documents
- Reviews regulatory documents to ensure completeness in accordance with sponsor requirements, ICH/GCPs, FDA Regulations, EMA, MHRA and other health authority regulations
List of Typical Skills For a Clinical Trial Associate Resume
1
Skills For Senior Clinical Trial Associate Resume
- Excellent interpersonal and communication skills (verbal and written) including good English and ability to maintain a high-level of confidentiality
- Demonstrated experience (at least one year) in clinical trial operations involving multiple projects involving cross functional, multi-site, teams
- Proficiency with standard business software, including experience using databases
- Demonstrate ability to the daily evolving business demands and opportunities while proactively seek methods to contribute toward resolution
- Good understanding of key principles of clinical and/or pharmaceutical development operations (in drugs, vaccines or medical devices)
- Good understanding of international logistics operations and contingencies
- Experience working in a team across multiple functional areas
- Experience maintaining Trial Master Files
2
Skills For Intern, Clinical Trial Associate Resume
- Related experience supporting clinical trials
- Two years experience in working with Trial Master Files
- Well organized and capable of managing multiple tasks with respect to priorities
- Proven ability to work in a team environment and with a wide variety of people, including external clients
- A good understanding of the clinical trial process and required CTA activities from study feasibility to study close out
3
Skills For Lead Clinical Trial Associate Resume
- Experience with using eTMF and CTMS systems
- Demonstrated accountability for tracking and retrieval of essential documents and on site investigator file creation
- Knowledge and operational experience working in the clinical trial environment
- Demonstrates concern for high quality outcomes
- Demonstrate concern for high quality outcomes
- Experience in clinical trial document management required
- CTMS (Clinical Trial Management System ) experience, preferably with IMPAC
- Relevant industry experience
4
Skills For Clinical Trial Associate, Outsourcing Resume
- Relevant experience in pharmaceutical industry or CRO
- Approximately 1-3 years of clinical research experience or applicable business environment required
- Clinical research experience or business environment required
- Two (2) - four (4) years of experience in an administrative support position
- Work independently Good listener / problem solver
- Experience in pharmaceutical industry or CRO
- Pharmaceutical industry experience
- Previous experience in clinical trials (e.g. clinical trial design, or execution and operations) is pre-ferred
- Work in a team as well as independentlyif required and to manage multiple priorities withsupport
5
Skills For Clinical Trial Associate Resume
- Clinical operations experience in a pharmaceutical or CRO setting
- Experience working with essential regulatory documents and specifically trial master file organization and structure required
- Familiarity with ICH principles of Good Clinical Practice and related regulations and regulatory guidelines
- Develop and maintain strong working relationships with both internal and external collaborators and stakeholders across all geographical regions
- Previous experience in handling clinical trial related documents
- Moderate experience in the set-up and maintenance of Trial Master File infrastructures and sound knowledge of regulatory requirements for global submissions
- Tracking and indexing of country specific essential documents for UK, Ireland, Netherlands and Belgium
- Collecting, quality review and submitting documents to the TMF
6
Skills For Senior Clinical Trial Associate Resume
- Understanding / familiarity with the drug development process and the pharma industry
- Preparing on site investigator files and materials for initiation
- Resupplying sites with study materials
- Liaising with sites to chase essential documents, CRF pages, queries, CTP docs
- Providing site monitor & site manager support
- Preparing confidentiality agreements
7
Skills For Intern, Clinical Trial Associate Resume
- Sending protocol packages to site
- Performing quarterly QC of TMF as appropriate
- Processing of contracts
- Meeting business needs and to support a customer-oriented approach for Trial Operations
- Understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites
8
Skills For Lead Clinical Trial Associate Resume
- Conduct study tracking support (e.g., CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates
- Evaluate, judge and make recommendations regarding staff. Ability to assist in teaching/coaching and setting an example of 'best practice'
- Assist Study Team by acting as a backup for receiving and triaging calls from investigator sites, CPLs,
- Support the Study Manager in creating, updating and tracking Microsoft Project study plans
- Efficient at meeting planning / writing minutes
- Prepares TMFs for archive, including finalizing documentation and performing final document reviews
- Support the Study Manager in creating, updating and tracking MS Project study plans
9
Skills For Clinical Trial Associate, Outsourcing Resume
- Aptitude for handling and proofreading data
- Have a significant role in managing the study documentation including
- Help generate the Clinical Study Report (CSR) appendices and participate in the development of Standard Operating Procedures and Working Practices
- Trouble-shoots TMF-related queries, including access and filing questions
- Manages Iron Mountain account, including maintaining inventory of off-site storage
- Assists with creating/updating TMF-related Work Instructions and SOPs, as needed
- Works with QA to develop SOP’s regarding TMF, Records Retention Room and Shared Drive posting of clinical trial documents
- Conduct study closure activities (sites, reconciliation activities, filing & archiving)
10
Skills For Clinical Trial Associate Resume
- Understand all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report
- Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, or project team
- Support study teams in administrative tasks and logistics (i.e. expenses, travel arrangements, meeting set-up including investigator meetings)
- Support document filing and organizing as needed
- Study Coordination, Tracking, and Reporting
- Accepts challenging assignments and new responsibilities
- Accept challenging assignments and new responsibilities
- Use varying communication methods appropriately (eg., email, voice mail, in-person)
- Proficiency using Microsoft Outlook, Word, Excel and PowerPoint
List of Typical Responsibilities For a Clinical Trial Associate Resume
1
Responsibilities For Senior Clinical Trial Associate Resume
- Supports other study related administrative tasks (scanning, emailing, filing, shipping, etc.)
- Collects, logs, tracks and files essential regulatory documents (TMF filing/coordinating)
- Assists with the management and meeting coordination of the members of our data safety monitoring boards (DSMB) and clinical event committees (CEC)
- Responsible for hand-on management and tracking of all aspects of the IITs/COOPs/3rd Party trials and maintaining study data within the CTMS
- Manages testing laboratories including selection of laboratories for the studies
2
Responsibilities For Intern, Clinical Trial Associate Resume
- Manages Clinical Research Organizations and ensures monitoring of studies, data collection and handling
- CSR Development and Reporting
- File and maintain the study administrative files locally and send original documents to central TMF. When applicable, ensure electronic filing
- Responsible for serving as clinical trial leader for a large-scale multi-country trial (Phases I-IV)
- General knowledge of IRT, eDC and other study tracking tools required
- Assists with preparing project status reports
- Maintains and schedules weekly team meetings and associated meeting agendas and minutes (draft, route for review, revise, distribute final to team and archive)
- Responsible for all study activation activities through completion of publication all while ensuring regulatory integrity and SOP compliance
3
Responsibilities For Lead Clinical Trial Associate Resume
- Responsible for maintaining constant knowledge of assigned studies and provide management with study information as requested
- Creates, maintains and oversees study files and archiving
- Study Start Up
- Departmental Tasks
- 10%: Study Close Out
- 15%: Study Management Tasks (as necessary)
- Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat
- Study and Project Coordination
4
Responsibilities For Clinical Trial Associate, Outsourcing Resume
- Coordinate and support internal recruitment-specific meetings to identify trends, share lessons learned, and deploy process improvements or new strategies to ensure best in class recruitment / retention campaigns across Alkermes’ studies
- Review of study files periodically for accuracy and completeness; prepare, handle and distribute of Clinical Trial Supplies and maintenance of tracking information
- Assist in organization of Investigators’ Meetings
- File, track and maintain TMF
- Maintain internal/external contact list
- Conduct electronic documentation and records management
- Perform document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation
- Ensure timely study entry and updates to ClinicalTrials.gov
- Can support the study team with the submission of clinical trials to ethics committees and competent authorities (either in Spain and in other countries) and responsible for reviewing investigators’ contracts
5
Responsibilities For Clinical Trial Associate Resume
- Support/Perform Research Contract negotiations (in English & local language, where appropriate ) with Hospital/Institution, Central Contracts & Out-Sourcing Group, and Celgene’s Legal Group, to ensure local Start Up timelines are adhered to
- Demonstrated ability to work in complex settings and deadline driven
- Track Site payments to ensure timely payments are reflective of the contract’s schedule
- Responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation
- Lead the multi-disciplinary team responsible for study completion
- Writes and reviews abstracts/manuscripts, etc. for presentation/publication at internal/external meetings
- Assists with assigned study management tasks as assigned including essential document collection and review, site monitoring activities, data management tracking and query resolution and the management and administration of Study Team Meetings, including scheduling meetings, agenda circulation, and minute preparation/circulation
- Obtain and track key study information as required, including site details, IRB submission and approvals, patient enrollment and screening data, informed consent (ICF) review and approvals, and other study specific details
- Strong interpersonal skills with the ability to manage multiple and varied tasks; demonstrated verbal and written communication skills; flexibility with respect to work assignments; organization skills
6
Responsibilities For Senior Clinical Trial Associate Resume
- Tracks and distributes study specific documents such as operational, pharmacy, and lab manuals to clinical research organization (CRO) and study sites if applicable
- Contacts study team members and external vendors under the direction of the Clinical Team Leader
- Assists in the coordination of investigator meetings and studies presentation materials
- Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required
- Review proposed offers/quotes with the CSC manager to make sure all details are taken into consideration (addresses, quantities, shipment conditions, timelines...) and if needed purchasing (markup or cost to deliver)
- Experience in pharmaceutical business required, preferably within supply chain, clinical operations, manufacturing or logistics environments
- Assist the Clinical Trial Managers with achieving key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, study execution, data collection, and close-out
- Assist in the preparation of study documents including, but not limited to, clinical protocols and amendments, case report forms and source document templates, informed consent forms, site training materials, site regulatory binder, site pharmacy binder, and clinical study reports
- Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines
7
Responsibilities For Intern, Clinical Trial Associate Resume
- Assist in the day-to-day operational activities and other specific projects as assigned within Clinical Operations
- Accountable for the maintenance of the electronic Trial Master Files (TMF) in accordance with SOPs
- Accountable to develop and review regulatory documentation to support study start up activities, including ensuring all site supplies are available on site for site initiation visits
- Attends Investigator Meetings and study-specific training for assigned trials
- Ensures all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned monitor
- Responsible for the follow up to collect outstanding documents
8
Responsibilities For Lead Clinical Trial Associate Resume
- Act as primary liaison for study sites and monitors to convey project information and answer questions in accordance with the CTM escalation pathway
- Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of clinical trial documentation
- Collaborates with the monitors to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics
- Responsible for communicating issues in accordance with the CTM escalation pathway to the monitors as appropriate
- Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for patient safety and regulatory compliance for all assigned sites
- Liaises with Procurement, Legal and Finance to secure confidentiality agreements, master service agreements, clinical trial agreements as appropriate
9
Responsibilities For Clinical Trial Associate, Outsourcing Resume
- Monitors recruitment remotely through IRT and EDC systems and/or communication with sites
- Prepares and reviews various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, retrieval of such documents as protocol, IB, etc.)
- Provides quality overview and consistency check on all developed ICFs and completes the informed consent checklist
- Responsible for the submission and correction of regulatory packages for drug release to the CTM for approval
- Responsible to assure adequate and appropriate dissemination of information according to the clinical study plan between sites and clinical project team staff to ensure project success
- Responsible to coordinate and secure IRB approval (local and central)
- Responsible to provide step by step guidance and partnership with sites to secure IRB approval
- Provide support in the in the daily activities of managing and coordinating the operational efforts in the development and implementation of research-driven, Investigator Initiated Trials, Cooperative Group and Third Party trials with close collaboration with the Medical Science Liaison/Field managers and research sites
- File and audit studies in the Trial Master File at the completion of the study or as required throughout the study
10
Responsibilities For Clinical Trial Associate Resume
- Contribute to the development and apply the distribution strategy (for IVR and non-IVR studies) that ensures continuity of IP at depots and investigational sites
- Trial Master File maintenance and filing of relevant documents according to ICH-GCP and SOPs (as
- Responsible for overall clinical study management, including planning, communication, coordination and practical tasks for the studies
- As necessary, support relabeling activity or transfer of IP between various sites
- Ensure adequate IP stock at depot and site levels
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