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Clinical data coordinator skills for your resume and career
15 clinical data coordinator skills for your resume and career
1. Patients
- Performed duties as clinical research associate- assisted clinical research nurse with clinical work up of patients participating in clinical trials.
- Directed enrollment and evaluation of patients in adherence with study-specific protocols.
2. Data Management
The administrative process that involves collecting and keeping the data safely and cost-effectively is called data management. Data management is a growing field as companies rely on it to store their intangible assets securely to create value. Efficient data management helps a company use the data to make better business decisions.
- Review and generate project-specific reports for tracking of data management study status and reporting to internal and external team members.
- Support clinical trials for CRO by performing meticulous data management activities to ensure accurate, consistent and complete clinical databases.
3. Data Collection
Data collection means to analyze and collect all the necessary information. It helps in carrying out research and in storing important and necessary information. The most important goal of data collection is to gather the information that is rich and accurate for statistical analysis.
- Relay information to clinicians or improvement teams based on data collection/abstraction in order to improve performance.
- Communicated data collection issues, data inconsistencies and laboratory issues with sites.
4. GCP
Google Cloud Platform (GCP) is a collection of cloud computing services that allow users to develop, deploy, and operate original applications on the web. GCP carries a cloud computing infrastructure that facilitates it in keeping track of the resources (e.g., storage, processing speed, and power, network connectivity, database queries, etc.) of an application or a website, whenever it is run on the cloud platform.
- Communicated with various sites, monitors and study coordinators regarding GCP's, proper data handling and protocol adherence procedures.
- Created and maintained uniform and standardized policies which meet Good Clinical Practice (GCP) standards.
5. Data Validation
Data validation is the process of reviewing and arranging data for efficient data analysis. Data validation includes checking data accuracy, quality of data source, and identifying the importance or relevance of the data.
- Assisted senior clinical data coordinators with data validation and error analysis to insure the accuracy and quality of the clinical study.
- Analyzed, proofed and reviewed data entry and data validation output to identify inconsistencies, errors and protocol violations.
6. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Managed patient throughout study endpoints, ensured quality data, and prepared for monitors/audits - No FDA 483 during my tenure
- Reviewed Post Marketing Reports of non serious reports and serious adverse event listings for FDA submission.
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CRF (Chronic Renal Failure) is a long-term condition where the kidney gradually stops functioning. It's the leading cause of other medical conditions like diabetes, cardiovascular diseases, or high blood pressure.
- Designed CRF, databases and required regulatory documents meeting departmental standard and compatibility with protocols in assigned therapeutic area.
- Participated in CRF development per data capture requirements per protocol.
8. Oncology
Oncology is defined as the facet of medicine that deals with cancer. Oncology also deals with the prevention and diagnosis of these diseases. A medical professional who has studied the discipline of oncology is referred to as an ‘oncologist'. An oncologist can further specialize in their discipline and become a medical oncologist, surgical oncologist, or radiation oncologist.
- Validated database design and edit check specification documentation for oncology and trail specific databases.
- Obtained knowledge of oncology and hematology parameters; including RECIST and study specific blood endpoints.
9. Electronic Data Capture
Electronic data capture is the process of gathering data using special computer programs and systems.
- Processed, reviewed and corrected site investigative data via electronic data capture.
- Utilized Oracle Clinical, and Oracle Clinical Remote Data Capture system, and RAVE Electronic Data Capture.
10. Quality Checks
Quality checks are a component of quality control aimed at ensuring that quality requirements are met. Internally, quality checks provide assurance to managers, and externally, it provides assurance to clients, federal departments, authorities, and certifiers.
- Verified completion of proper documentation and conducted quality checks to ensure data integrity.
- Perform validation documentation quality checks to ensure documentation will pass audits.
11. Clinical Trial Data
- Reviewed clinical trial data for completeness, accuracy, validity, protocol adherence, and appropriateness of documentation.
- Defined and maintained clinical trial databases for a pharmaceutical company.
12. Data Queries
- Verified patient documents by performing data queries that included resolving file errors and integration of additional patient data as needed.
- Reviewed, generated and resolved automated study specific data queries.
13. Patient Data
- Reviewed patient data for completeness and accuracy prior to entering into database.
- Used statistical software (SPSS and MS Excel) to drill-down databases with greater than 200,000 patient data sets quarterly.
14. UAT
UAT stands for user acceptance testing, and it is the last phase in the software testing process that determines whether the software is fit for the purpose it was built or not. UAT checks two main things; whether the software fulfills the business requirements and can it be used by the end-users. It is the final and most critical step in the testing stages and it determines whether the software should be introduced in the market or not.
- Validate programmed edit checks and changes to programmed components in the User Acceptance Testing (UAT) database.
- Performed UAT to ensure test data entry is as expected and created test data entry reports.
15. Completion Guidelines
- Develop an understanding of study protocols and completion guidelines for clinical trials.
- Assisted in developing study-related documents such as eCRF completion guidelines, data review guidelines etc.
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List of clinical data coordinator skills to add to your resume
The most important skills for a clinical data coordinator resume and required skills for a clinical data coordinator to have include:
- Patients
- Data Management
- Data Collection
- GCP
- Data Validation
- FDA
- CRF
- Oncology
- Electronic Data Capture
- Quality Checks
- Clinical Trial Data
- Data Queries
- Patient Data
- UAT
- Completion Guidelines
- SAS
- Informed Consent
- CRO
- Quality Control Procedures
- Query Resolution
- Data Review
- Clinical Studies
- CDM
- CDC
- Data Transfers
- User Acceptance
- Clinical Sites
- Data Entry Guidelines
- Test Data
- DCFS
- External Data Reconciliation
- Phase III
- Clinical Trial Management
- Status Reports
- Database Lock
- Oracle Clinical
- MedDRA
- SQL
- Study Timelines
- QA
- Data Entry Screens
- ECG
- Discrepancy Management
- Query Generation
- CRAs
- OC
- Edit Specifications
Updated January 8, 2025