A Clinical Data Associate is hired to handle the clinical information of the patients, including appointments and other official documents. A well-written Clinical Data Associate Resume mentions the following core duties and tasks – designing a database design for new protocols; ensuring timely and accurate data to appropriate personnel, validating the database; assisting in the preparation of clinical data budgets and reviewing specified protocols and implementing clinical data management plans; performing data review in conjunction with medical and safety review; managing queries and updating the database; supervising data management activities, and developing data systems plans and forms.
Summary of skills that can highlight a resume includes – experience in clinical data management; skillful with clinical trial study protocols and web-based data entry systems; solid knowledge of data collection, medical terminology, and clinical research principles; proficiency with relevant software; and a good understanding of the FDA guidelines. Generally, a degree related to science or medicine is considered suitable for this post.
Objective : Highly qualified Clinical Data Associate with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and I would excel in the collaborative environment in which your the company prides itself.
Skills : MS Office, Clinical Skills, Managing Skills.
Description :
Assisted the Clinical Data Manager with the development of study-specific data management plans.
Developed the study-specific data management manuals including data entry instructions and data handling conventions.
Assisted with the review and finalization of study-specific CRFs in EDC and CDMS (Paper studies).
Created annotated CRFs consistent with the TI or sponsor database dictionary.
Set up study databases in Clindex (CDMS) in accordance with the database definitions outlined in the data management plan.
Developed a validation protocol for clinical trial database validations.
Drafted documentation for clinical trial database validations and participate in the validation execution for paper and EDC studies with knowledge of CDISC/CDASH standards.
Experience
2-5 Years
Level
Junior
Education
GED
Clinical Data Associate Resume
Objective : As a Clinical Data Associate, responsible for Interacting with sites to resolve data discrepancies, and also coordinating and participating in protocol-related conference calls.
Performed a pre-entry review of CRFs according to audit plan and department operating procedures.
Resolved any support services discrepancies between the first pass and second pass entry.
Generated, tracked, and resolved data clarifications via an in-house tracking system.
Coded medical terminology and medications using a project-specific dictionary.
Performed Quality Control review of the database against the working copies of the CRFs to ensure that all data had been entered accurately.
Reviewed researched and resolve outstanding data entry issues.
Performed medical coding for adverse events, medications, and medical conditions.
Experience
2-5 Years
Level
Executive
Education
BS In Nursing
Clinical Data Associate Resume
Objective : Clinical Data Associate, Identifying, resolving, and updating data discrepancies, and also making changes to the data management database as required, and also Generating, tracking, and resolving data clarifications and queries.
Skills : Microsoft Office Suite, Documenting Skills, Clinical Skills.
Description :
Responsible for clinical data review, edit check review, and data clarifications on complex projects.
Responsible for end -to -end CRF design.
Responsible for query generation/resolution, coding of terms, and reconciliation activities to support the delivery of clinical data according to client quality.
Prepared forms for data entry as determined by review guidelines and standard department procedures.
Documented, resolved, and integrated data queries.
Performed first and second pass data entry of Case Report Forms into the database.
Reviewed listings for Quality Control.
Experience
2-5 Years
Level
Executive
Education
BS
Clinical Data Associate Resume
Objective : Highly motivated, experienced, and passionate candidate seeks to further a career in a Clinical Data Associate position that can utilize my technical skills and management knowledge to benefit mutual growth and success.
Skills : Supervising Skills, Multitasking, Problem Solving SKills, Data Management Skills.
Description :
Interacted and collaborated with project data manager, peers, supervisor, and other project team members.
Served as a client contact person for project meetings and CDM status updates and managing external vendors.
Converted various documents including CRF, DMP, and DVS into the English language for the purpose of FDA submission.
Adhered to NIH Clinical Data Management project timelines on multiple complex protocols.
Supported data abstraction and data entry of assigned studies gather and enter data in accordance with SOPs and protocol-specific processes.
Worked in a team environment to support eCRF design and end-user testing.
Ensured adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout a clinical study.
Experience
2-5 Years
Level
Executive
Education
BS
Clinical Data Associate Resume
Headline : As a Clinical Data Associate, responsible for Working closely with Clinical Affairs project team members to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
Skills : Microsoft Office Suite, Data Management, Database Design, Quality Assurance.
Description :
Developed protocol-specific data management plans ensuring alignment with protocol and data quality standards.
Conducted data quality checks and data reviews.
Provided data management support in preparation for and response to continuing reviews, monitoring visits, data safety monitoring board (DSMB) meetings, and audits.
Participated in cross-functional process initiatives and clinical research team meetings.
Abstracted and graded adverse events based on the protocol specifications and SOPs.
Maintained study/site information in the clinical trial management database.
Reviewed case report forms for completeness and compliance with protocol guidelines and Good Clinical Practice.
Experience
5-7 Years
Level
Executive
Education
BS
Clinical Data Associate Resume
Headline : Seeking a Clinical Data Associate position for growth and development in Clinical Research which utilizes my expertise in various therapeutic areas of Clinical Data Management.
Skills : Program Management, Clinical Skills.
Description :
Developed and delivered business-relevant reports/analyses for use at all levels in SAS.
Ensured completeness, correctness, and consistency of routine clinical data.
Assisted in the implementation of routine clinical data management processes with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
Assisted in eCRF documentation guidelines Reviews study protocol and assists site coordinators with reports to meet the requirements in a timely manner.
Identified, tracked, and resolved routine queries.
Utilized routine reports to track study progress and ensures timeliness and quality expectations are met.
Familiar with web-based Electronic Data Capture (EDC) and clinical data management systems.
Experience
5-7 Years
Level
Executive
Education
M.S. In Health Informatics
Clinical Data Associate Resume
Objective : Seeking a Clinical Data Associate position, responsible for Reviewing clinical trial data in accordance with Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
Skills : Data Warehouse, Clinical Trials, Good Communication.
Description :
Ran ancillary programs to support the review of clinical trial data.
Generated, resolved, and tracked queries to address problematic data identified during data review activities and apply proper modification/correction to the database.
Applied quality control procedures and checks to ensure data quality standards are achieved.
Assisted with the reconciliation of the central laboratory and /or third-party vendor data.
Assisted with the aggregate review of clinical data by patient, site, and /or project to identify data trends (patient safety, compliance, etc.) and/or data inconsistencies that require further investigation.
Conducted and review data validations after data entry.
Joined as a trainee in the clinical SAS programming department.
Experience
2-5 Years
Level
Executive
Education
G.E.D
Clinical Data Associate Resume
Objective : Highly skilled Clinical Data Associate, responsible for Completing appropriate documentation of databases and project files according to project guidelines, and also assisting the Data Manager by reviewing data listings to identify erroneous data before data safety cuts.
Skills : MS Office Suite, Oracle Clinical, Oracle Clinical Remote Data Capture.
Description :
Assisted the Clinical Data Manager with the generation of data clarification forms (DCFs).
Reviewed Case Report Forms (CRFs) generated from clinical trials for completeness and accuracy using Edits, CRF listings, manual review, and other appropriate guidelines.
Updated the database and CRFs as a result of answered DCFs, patient profiles, or edit reports.
Discovered, resolved, and documented areas of discrepancy in data collected from investigational sites.
Maintained and updated computer-generated databases, filing systems for CRFs, and data logbooks demonstrating the status of data received, coded, and edited.
Assisted with the quality assurance of computer-generated reports and the production of accurate and appropriate databases to be used for preparing clinical summaries, NDA submissions, and ad hoc requests.
Responsible for the drug reconciliation function for domestic and international clinical study trials.
Experience
2-5 Years
Level
Executive
Education
High School Diploma
Clinical Data Associate Resume
Headline : Seeking employment that will allow me to grow professionally, while utilizing my strong organizational, educational, and exceptional people skills for the betterment of your organization. Capable of working in a team atmosphere as well as independently with minimum supervision, and committed to providing high quality service to every project.
Skills : Microsoft, Type 60 Wpm, Spanish, Clinical SKills.
Description :
Assisted with a review of Case Report Forms, Edit Checks, Data Management Listings, Query Listings, and Patient Profiles for data cleaning.
Coordinated internal review of clinical data and tracking of data cleaning activities, including locking and unlocking.
Assisted with identifying data trends and/or issues.
Reviewed study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner.
Utilized routine reports to track study progress and ensured timeliness and quality expectations were met.
Prepared a monthly workload report and streamlined the accountability function.
Proposed and participated in the design of an Oracle relational database for the study drug reconciliation process.
Experience
5-7 Years
Level
Executive
Education
BA In Health Science
Clinical Data Associate Resume
Objective : Clinical Data Associate with 5 years of experience in Assisting with data management start-up activities, database cleaning and lock activities including review and development of case report forms, data management plans, and database development.
Skills : Microsoft Office Suite, Interpersonal Skills, Clinical Skills.
Description :
Maintained clinical study files to include all clinical study documentation.
Communicated with study site personnel regarding participant enrollment and data forms submission.
Interacted with sites to resolve data discrepancies.
Coordinated and participated in protocolrelated conference calls.
Drafted accurate agendas/minutes and disseminates call materials in a timely manner.
Completed data management activities to meet project timelines from study start-up to database lock.
Assisted with data management start-up activities, database cleaning, and lock activities including review and development of case report forms, data management plans, and database development.
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