Clinical Data Coordinator Resume Sample
Claudine Ankunding
5217 Kunde Isle,
Dallas,
TX
+1 (555) 635 4072
Work Experience
Senior Clinical Data Coordinator
06/2017
-
PRESENT
Boston, MA
- Experience in a clinical/scientific environment
- Excellent organizational, communication, and data management skills (detailed oriented)
- Demonstrated proficiency in data management and computer software applications (MS Word, Excel, Outlook)
- Clinical Data Programming: Good knowledge of Oracle and/or SAS
- Laboratory Data Programming: Good knowledge of VGL and/or BizTalk and/or C# and/or .NET
- Solid understanding of clinical drug development process
- Excellent organizational, communication, and technical database skills
- Responsible for reviewing & maintaining registration compliance information in accordance with change control processes
Clinical Data Coordinator
05/2010
-
02/2017
Los Angeles, CA
- Work with US, ex-US & CMC areas to establish data categorization and provide analysis of data in system
- Major job Responsibilities
- Receive and enter registration compliance data into system
- Review data & determine if new categories/classifications are required
- Responsible for maintaining keyword lists associated with the data entry requirements
- Work with global regulatory affairs area representatives & affiliates to build relationship and common understanding of the requirements for Registration Compliance
- Assimilate disparate information from multiple resources, analyze for trends, adjust and raw inferences
Clinical Data Coordinator Temporary Position
10/2004
-
02/2010
Phoenix, AZ
- Track metrics associates with data capture/entry effort
- Execute business processes for Registration Compliance
- In a related area including manufacturing, regulatory affairs, quality in the pharmaceutical, medical device, or other healthcare industry
- Experience/understanding/use of software tools
- Responsible for reviewing & maintaining registration compliance information in accordance with change control processes. Work with US, ex-US & CMC areas to establish data categorization and provide analysis of data in system
- Receive and enter registration compliance data into system. review data & determine if new categories/classifications are required
- Track metrics associates with data capture/entry effort. Execute business processes for Registration Compliance
- Apply protocol specific knowledge to execute the tasks assigned within the project
Education
University of Central Florida
2000 - 2004
Bachelor's Degree in Clinical
Professional Skills
- Excellent communication and interpersonal skills, both verbal and written skills
- Experience using EMR and strong computer skills
- Excellent written and verbal communication skills with strong ability to communicate clearly and concisely
- Strong computer literacy and keyboard skills required
- Experience working in a clinical data management capacity with experience leading/managing a clinical study
- UAT, validation and/or general testing experience
- Demonstrated experience in edit check specification design – someone who has looked at a protocol and gave input to creating CRF’s
How to write Clinical Data Coordinator Resume
Clinical Data Coordinator role is responsible for organizational, supervision, computer, general, database, microsoft, simultaneously, excel, credit, training.
To write great resume for clinical data coordinator job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Data Coordinator Resume
The section contact information is important in your clinical data coordinator 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 Data Coordinator Resume
The section work experience is an essential part of your clinical data coordinator 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 data coordinator 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 data coordinator position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Data Coordinator resume experience can include:
- Review Data Management project documents and their specifications. Examples of these documents are the Study Specific CRF, Data Management Plan, Data Quality Checks, eCRF Completion Guidelines, Data Transfer Agreements, etc
- Effectively work within the EDC platform to provide help desk support. This includes assisting with tracking and documenting end user training
- Obtains and maintains valid Dangerous Goods Shipping Certification
- Develop and maintain good communications and working relationships with teams and external clients
- Perform database and report validation tasks as needed
- Proactively works with Lead Data Manager on prioritization of tasks assigned
Education on a Clinical Data Coordinator Resume
Make sure to make education a priority on your clinical data coordinator resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical data coordinator 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 Data Coordinator Resume
When listing skills on your clinical data coordinator 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 data coordinator skills:
- Solid skills in using Microsoft Office Programs
- Good organizational, communication, leadership and computer skills required
- Very good computer skills primarily MicroSoft Excel and Word
- With guidance, prepares data validation documents and conducts data validation testing
- Intermediate MS Excel skills including pivot tables, Vlookup and other logic functions
- Able to present information effectively to individuals and small groups
List of Typical Experience For a Clinical Data Coordinator Resume
1
Experience For Senior Clinical Data Coordinator Resume
- Previous experience with data management systems and familiarity with clinical data analysis and reporting
- Establish priorities and to act independently
- The demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and rules are essential
- Highly skilled with MS Office, especially Excel, Word and Publisher and PowerPoint
- Operate autonomously with infrequent managerial input
- Create and maintain all validation test scripts for the current online inventory software system and any other new equipment or software systems
- DM experiences
- LIMS or EDC system experience
- Experience with relational databases, knowledge of the Clinical Trials and/or pre-Clinical study process and FDA GxP
2
Experience For Early Talent Clinical Data Coordinator Resume
- Industry experience in data-management or Data Coordinator required
- Indexing Operator (IO)
- Assist with ongoing filing and archiving data management documents as directed; including the filing and archiving of such documents in the TMF
- Process room charges for the Cath and EP Labs utilizing clinical databases including XIMS and Omnicell
- Perform routine data cleaning tasks via query issuance, review and resolution of the query on data entry within the database
- Maintains timely patient follow-up by accurately reviewing the study specific follow-up schedule in the protocol and completes follow-up CRFs
- Implements training of all new Data Coordinators with Nurse Educator. (Preceptor Role)
- Act as a single point of contact (internal expert) for specific processing task(s) on a project
3
Experience For DRG / Clinical Data Coordinator Resume
- Ensure accuracy of the patient database by updating key elements in XIMS
- Review procedure report for billing consistency and accuracy
- Maintains current knowledge of ACC data collection and/or reporting process as well as changes to various definitions
- Ensures Self-Evident Correction process and data handling standards are appropriately applied
- Identify and assess data management related issues and trends; propose resolutions to the Lead Data Manager and track issues through to completion
- Perform vendor reconciliation tasks as needed
4
Experience For Clinical Data Coordinator Temporary Position Resume
- Perform SAE reconciliation tasks as needed
- Perform Local Lab range management as needed
- Perform study archival tasks as needed
- Maintain data status progress/metric reports and provide routine updates on the reports to the Lead Data Manager/project team at defined intervals
- Act as an integral member of the data management team by working closely with all team members, fulfilling project related deliverables to meet contracted timelines and attend team meetings as assigned
- Fulfill tasks as designated by the Lead Data Manager or Clinical Team Lead/ Project Manager
- Collects data from various sources including medical records, clinical information systems, logs/records, interviews, national and state databases and governing organizations
- Manages requests for data and provides comprehensive quality management reports including utilization, outcome studies and scorecards. Generates summary reports of clinical measures and required regulatory / accreditation measure for administrative and clinical staff
5
Experience For Clinical Data Coordinator Resume
- Maintains various quality databases including loading import files, generating and working data status reports. Verifies accuracy of records, produces export files and identifies inconsistencies in system operations and alerts appropriate staff
- Experience in the pharmaceutical/clinical research environment as Clinical Data Coordinator or equivalent role
- Prepares reports and assists with statistical analysis
- Assures timely submissions of research data, laboratory specimens, and query correspondences to all research affiliates and statistical centers
- Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Contract Research Organizations, and employees of Hackensack University Medical Center
6
Experience For Senior Clinical Data Coordinator Resume
- Organizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits
- Verifies that all patients have provided informed consent prior to entering study specific data
- Records accurate data by completing paper or electronic CRFs
- Obtains consent for minimal risk studies
- Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs
- Resolves data queries accurately and within study specific timeframes
7
Experience For Early Talent Clinical Data Coordinator Resume
- Maintain adequate inventory of research supplies necessary for research activities. Ensures supplies and kits are current and safely disposes of expired/closed supplies
- Centrifuges human specimens per study specific laboratory manual guidelines
- Processes and ships human specimens and biologic agents per protocol guidelines and Federal Regulations
- Coordinates workflow related to data collection
- Responsible for completeness, timely delivery and quality of clinical data
- Lead and coordinate other team members within the department on assigned studies
- Mentor project team members and be a subject matter expert when needed
- Manage project timelines, quality issues and justify out-of-scope
- Leadership role in a specific area or process on a large study with guidance
8
Experience For DRG / Clinical Data Coordinator Resume
- Maintains regulatory binders in accordance with FDA guidelines. Assists research nurse in the preparation of all audits performed by various governing agencies, study monitors, and internal affairs
- Obtains patient consent for minimal risk studies
- Ensures regulatory binders are maintained with essential study documents
- Reports, tracks, and files off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record
- Participate as part of a team on various project(s)
- Report metrics and data trends on project(s)
- Identify data conflicts and issues on project(s)
- Work with personnel from research sites globally to resolve data conflicts
9
Experience For Clinical Data Coordinator Temporary Position Resume
- Reconcile data from multiple sources; and
- Create and update study documentation on project(s)
- Clinical data review, query generation/resolution and reconciliation activities to support the delivery of clinical data to clients
- Review clinical trial data in accordance with Data Management Plans and applicable standardized data management processes to identify erroneous, missing, incomplete, or implausible data
- Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification/correction to the database
- Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings/procedures used as tools for the data review and discrepancy management activities
- Manage project timelines and quality; determine resource needs; identify out-of-scope work
- Serve as Data Operations Coordinator or Data Team Lead
10
Experience For Clinical Data Coordinator Resume
- Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+
- Perform routine QC of data for multiple complex projects at various stages of data handling to ensure that all data are reliable and have been processed correctly (e.g., quality check of source data, databases and reports as required)
- Establish strong communication with MIRTH team, LIMS team, test method leads, project managers and all other stakeholders
- Communicate with Project Managers, LIMS team and test method leads on a regular basis to meet data management deliverables for multiple projects and ensure milestones meet timelines and quality deliverables
- With minimal guidance, support Clinical Data Management (CDM) team with comprehensive CDM process and technical expertise in executing data projects
- Perform extraction of data and generate required reports as requested
- Work with project team to identify and resolve data issues
List of Typical Skills For a Clinical Data Coordinator Resume
1
Skills For Senior Clinical Data Coordinator Resume
- Very good Math Skills
- Hands on SAS programming experience in a pharmaceutical setting
- Good spoken and written knowledge of English language with the ability to prepare written communications using correct spelling, grammar and punctuation
- Knowledge of patient medical records and skill in accessing them using electronic medical records and paper charts
- Experience with working on Phase I- IV study trials within the medical device and/or pharmaceutical industry
- Experience with MedDRA/Adverse Event (AE) Coding
- Maintain strong working relationships with the LIMS team, functional leads, project managers and all other stakeholders
- Highly experienced in performing Quality review of clinical data
2
Skills For Early Talent Clinical Data Coordinator Resume
- Have a strong understanding of research protocols and implementation
- Experience with scientific writing capabilities and with IRB protocol creation
- Related experience and 2+ years in clinical data management
- Exercise excellent attention to detail required
- EDC system and data review experience
- Validate an entry database design
- Work independently; organizes, prioritizes, and follows through with results
- Experience in online research, survey construction
3
Skills For DRG / Clinical Data Coordinator Resume
- Experience with analysis and efficient presentation of data such as abstracts, info graphics, manuscripts and posters
- Creating and managing study related regulatory dcouments for the Institutional Review Board (IRB)
- Understanding of data management process from study start-up through to database lock
- Managing the Clinical Data Management documents in MasterControl
- Perform data cleanup projects and other efforts related to researching and updating incomplete or missing information
- Position requires long periods of keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time
- Perform data remediation and other efforts related to researching and updating incomplete or missing information
- Verifies data entered into the computer by checking printouts/reports for errors and correcting as required
- Assist in logging and monitoring of physical location of source documents
4
Skills For Clinical Data Coordinator Temporary Position Resume
- Assist with writing the Standard Operating Procedures for the department
- Participate in the development of new protocols, including program specific protocols, specifically focusing on data management requirements
- Clean the clinical database, which includes generating and resolving data clarifications
- Creates paper patient files; prepares paper patient files for scanning and archiving
- Ensure adherence to applicable regulations, GCP and GDP, and support the Clinical Data Manager in establishing consistent practices
- Assume responsibility for all activities relating to 20+ studies over the course of 1 year
- Basic understanding of Drug Development Process and its relevance to Data Management
- Basic understanding of database technologies
- Design and implement data using statistical programs; maintain and manage all databases; format and retrieve data in report form
5
Skills For Clinical Data Coordinator Resume
- Coordinate end-to-end delivery of data management services for multiple projects with some guidance, ensuring quality deliverables on time
- Assure compliance with protocols and assist with audits by regulatory or funding agencies
- Conduct IRT and EDC UAT testing
- Interpret diagnostic imaging, pathology, hematology, oncology related reports
- These include, but are not limited to, those for NMDP, IBMTR (full reporting) and FACT. Coordinate the FACT inspection of the program
- Participate in the monthly FACT meetings; presenting reports (Mortality, Chart Audits, CAE, E&A) as required
- Coordinate, with CIC, the need for data collection and timely reporting of SAEs, for protocol changes and deviations and for the DSMB
- Liaison for Patient Financial Services and Medical Records to ensure accurate and timely based patient billing
6
Skills For Senior Clinical Data Coordinator Resume
- Assists the Monitors, Clinical research Coordinators and PIs in the organization and preparation of Site Initiation Visits (SIV)
- Attend site disease group tumor board meetings and site disease group collaborative meetings usually composed of PIs, sub-PIs, CRCs, IT, and Regulatory Staff
- Assist the Clinical Research Coordinators ensuring that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner
- Assists PI in obtaining informed consent and documents the informed consent process as required. Compiles patient data and presents those to the PI for their determination of patient eligibility for protocol enrollment
- Experience with Clinical database applications such as EDC and CTMS
- Experience with Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology including CDISC and CDASH
- Responsible for overall knowledge of protocols as assigned by the Director, Clinical Trials Office. Maintenance of screening/enrollment logs for each assigned protocol
- Build Programmer (Build Prog)
- Custom Function Programmer (CF Prog)
7
Skills For Early Talent Clinical Data Coordinator Resume
- Data Management Programmer (DM Programmer)
- Data Management SAS Programmer (SAS Prog)
- Database CRF Annotator (DB CRF Annotator)
- Lead Programmer (Lead Prog)
- Maintenance Programmer (Maint Prog)
- SAS Programmer (SAS Prog)
- Provide status updates related to project tasks to management as necessary
- The primary goals are to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams
8
Skills For DRG / Clinical Data Coordinator Resume
- Also includes Case Report Forms; initiating the purchase of CRF’s, diaries, and related documents from clinical protocols, preparing the study database dictionary; developing quality assurance database checks
- Also includes Case Report Forms; initiating the purchase of CRF's, diaries, and related documents from clinical protocols, preparing the study database dictionary; developing quality assurance database checks
- Pharmaceutical research experience required
- Provide accurate data acquisition and furnish well-documented study databases to the clinical and statistical teams
- Initiate the purchase of Case Report Forms, diaries, and related documents from clinical protocols
- Prepare the study database dictionary
- Develop quality assurance database checks
- In a related area
9
Skills For Clinical Data Coordinator Temporary Position Resume
- Medical terminology exposure required
- Understand basic financial management concepts
- Able to make independent decisions within scope of authority and considers the impact of decisions on other groups/people
- Data review and query generation
- College graduate, science background if possible but not necessary
- Close attention to Detail is very important
- Performs quality work only
10
Skills For Clinical Data Coordinator Resume
- Work closely with IT support and external data sources
- Serve as a liaison with regional and national industry colleagues
- Focus and complete repetitive tasks for an extended period of time
- Knowledge of GCP guidelines and clinical trials
- Flexibility and capability to multitask and meet established deadlines
- Work with spreadsheets (such as Excel)
List of Typical Responsibilities For a Clinical Data Coordinator Resume
1
Responsibilities For Senior Clinical Data Coordinator Resume
- Support development of data management standard operating procedures, guidelines, and conventions
- Participates in Post Market Surveillance reporting as appropriate
- With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
- Assist with identification and correction of data errors in accordance with quality assurance procedures
- Handle confidential material and adhere to data security and confidentiality requirements
- Assist with study close-out activities to verify data integrity and data completeness
2
Responsibilities For Early Talent Clinical Data Coordinator Resume
- Communicates with data management staff regularly on data management issues
- Perform tasks as assigned to assist with the smooth operation of the Clinical Data Management
- Provides general support to Clinical Data Management staff and project management teams
- Provide technical expertise in conjunction with internal and external clients
- Program database manipulation and transfers of data for internal and external clients
3
Responsibilities For DRG / Clinical Data Coordinator Resume
- Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables
- Performs all data coordination and some elements of data management activities for assigned studies on time and with high quality, as appropriate
- Track case report forms
- Update the clinical database
- Perform QC audits of the clinical database
- Reviews data to confirm the patient(s) eligibility for investigator initiated clinical trials
- Regularly monitors protocol for revisions, amendments or clarifications, revises CR/Flowsheets, recommends database changes, and communicates revisions to network staff (if applicable). Works with information technology on database field or table revisions and provided the appropriate codes and descriptions (if applicable) (10%)
4
Responsibilities For Clinical Data Coordinator Temporary Position Resume
- Upon Study completion, submits and validates data to clinical research and health outcomes network, as well as applicable local, state and federal accrediting bodies and regulatory agencies. (10%)
- Contact patient(s) for study specific requirements (if applicable) can document and provide key database entries to ensure data integrity, accuracy, and consistency. Works with site staff to resolve queries. (20 %)
- Regularly reviews protocol, amendments, or clarifications, and revisions for eDC data entry. Completes all study training, eDC training, or any additional training (if applicable) (20 %)
- Manage the data collection, participant follow up, and study close out processes
- Collaborate with research scientist and study sponsors to develop, build, and test online surveys
- Advise clients on best practices in data collection processes
- Collaborate with the research scientist, principal investigator/project lead and other senior staff in developing and facilitating ethnographic interviews, focus group material, protocols, project presentations and other necessary supporting materials
5
Responsibilities For Clinical Data Coordinator Resume
- Actively participate in study database setup and testing
- Assist with development or review of study specific DMP, CRF/eCRF development, edit check specifications, and other data management documents
- Support managing clinical study data through subject data reviews, data listings, identifying data discrepancies, verifying data query resolutions, reviewing medical coding, conducting SAE reconciliation, etc
- Generate data listings and ad hoc reports to assist in data review
- Participate in process improvement discussions to improve department efficiency and productivity
- Support internal and external clinical study audits conducted by internal Quality group and/or by regulatory authorities
6
Responsibilities For Senior Clinical Data Coordinator Resume
- Data Management: Extract data from source documents. Complete electronic Case Report Forms in the RedCap database. Assist team with the creation of source document tools. Assist in reporting of data for quality and research projects. Assist in the creation of new databases and transition of databases to new platforms
- Administrative: Make copies, fax and mail documents. File study documents and correspondence
- Regulatory: Assist with preparation of initial regulatory documents and update as needed. Create and maintain regulatory binder and file regulatory documents. Route regulatory documents for signature
- Interact and work collaboratively with physicians, residents, other clinical services, investigators and clinical research team on multiple projects
- Reconcile patient charges and usage of equipment on a daily basis
- Communicates and interacts with physicians to ensure all information is obtained accurately and completely
- Collaborates with Cardiology IT to develop queries and streamline processes to help improve workflow for the Cardiac Catheterization and Electrophysiology Laboratories
- Analyzes data/findings, identifies trends, makes recommendations for and participates in departmental and hospital improvement initiatives to ensure optimal financial and operational performance
7
Responsibilities For Early Talent Clinical Data Coordinator Resume
- Assist with ensuring accurate capture of clinical data required for reporting of NYS DOH and ACC registries
- Reads and understands clinical study protocols
- Reviews and provides comments on draft CRFs
- Reviews, provides input into and follows the Data Management Plan
- Creates CRF Completion Guidelines
8
Responsibilities For DRG / Clinical Data Coordinator Resume
- Assigns Sites, Field Clinical Engineers and Patients to Sites
- Creates Data Entry Guidelines
- Enters study data into Clinical Database
- Supports discrepancy management process
- Handles receipt of clinical documents received though the general fax and email accounts and triages and distributes other received clinical documents (clinical data forms, regulatory documents, correspondence and other supporting clinical documentation) to appropriate internal personnel
- Addresses assigned Clinical Data Operations Help Desk/Support requests
- Reconciles monitored CRF with entered CRFs
- Perform data quality audits
- Accurately maintains administrative data in the clinical trial database: sites, physician and internal data Analyzes problems and determines appropriate clinical data coordination solutions. Resolves and/or facilitates resolution of problems
9
Responsibilities For Clinical Data Coordinator Temporary Position Resume
- Communicates clearly and effectively with peers, study teams and management as appropriate to support studies and goals. Maintains positive and cooperative communications and collaboration with all levels of employees and Clinical Site personnel
- Knowledge, skills, and abilities related to Open Heart Surgery patients throughout the care continuum
- Contributes to continuous improvements in Clinical Data Coordination processes and templates, as needed/assigned
- Is a Subject Matter Expert (SME) in one or more areas within Clinical Data Coordination activities
- Complies with U.S. Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH), ISO 14155, other regulatory requirements, Company policies, operating procedures and processes
- Experience with the U. S. Food & Drug Administration (FDA), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) as they apply to clinical data management and to the clinical trial process
10
Responsibilities For Clinical Data Coordinator Resume
- Work with Clinical Data Management Systems
- Identifies all cases that meet criteria for abstraction into the STS registry
- Assess appropriate inclusion/exclusion of data based on defined data dictionary
- Utilizes clinical expertise to abstract patient data relative to specific cases. Queries providers to clarify and prepare data as needed
- Identifies, understands, and communicates and meets the Harvest schedule for the STS database
- Assists in the evaluation of data dictionaries
- Supports committees, teams, and leadership with data collection, analysis, and identification of trends, benchmarks, and variances in data
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