Job Summary:

• List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform. 
• Performs all data management activities for assigned studies
• Case Report Form (CRF) development and maintenance
• Edit Check specifications development and maintenance
• Data Management Plan development and maintenance
• Data Quality checks and discrepancy management
• Analyzes data, identifies trends, prepares data tables for clinical reports
• Database setup testing and Edit Check programming testing
• External data handling o Elements of device reconciliation
• Participate in Post Market Surveillance reporting as appropriate

Skills on Resume:

• Data Management (Hard Skills)
• CRF Development (Hard Skills)
• Edit Check Specs (Hard Skills)
• Data Plan Oversight (Hard Skills)
• Quality Checks (Hard Skills)
• Data Analysis (Hard Skills)
• Database Testing (Hard Skills)
• External Reconciliation (Hard Skills)

Job Summary:

• Data entry from EMR to EDC must be accurate and consistent.
• Works with Monitors for query resolution.
• Communicates with data management staff regularly on data entry, analysis and data management issues.
• Provide status updates on data entry tasks.
• Adheres to data security and confidentiality requirements when handling confidential data.
• Contact patient(s) for study specific requirementscan document and provide key database entries to ensure data integrity, accuracy, and consistency.
• Works with site staff to resolve queries
• Determines appropriate information to collect for studies, determines data flow, and collection timing.
• Complete study specific flow sheets
• Assist with data analysis and reporting associated with queries or data discrepancies
• Regularly reviews protocol, amendments, or clarifications, and revisions for eDC data entry.
• Completes all study training, eDC training, or any additional training

Skills on Resume:

• Accurate Data Entry (Hard Skills)
• Query Resolution (Soft Skills)
• Data Management Communication (Soft Skills)
• Status Reporting (Soft Skills)
• Data Confidentiality (Soft Skills)
• Data Integrity Management (Hard Skills)
• Study Information Analysis (Hard Skills)
• Protocol Compliance (Soft Skills)

Job Summary:

• Abstract clinical data from subject source documentation
• Enter clinical data into the study specific EDC case report forms
• Update the EDC following verification of subject data, including the resolution of data queries
• Track site goals and case report form completion.
• Support and adhere to Good Clinical Practices (GCP) guidelines, FDA, Institutional Review Board (IRB) and HIPPA regulations, Site Operating Procedures and ethical standards for the conduct of research clinical trials.
• Work closely with onsite team to confirm appropriate consenting is being performed and documented prior to data abstraction
• Maintain Caris and Site requirements for source document management and request for information.
• Willingness to travel to multiple investigative sites 
• Communicate effectively with the research team, investigator(s), Clinical Research Associate(s), study sponsor and ancillary staff.

Skills on Resume:

• Data Abstraction (Hard Skills)
• EDC Data Entry (Hard Skills)
• Data Verification (Hard Skills)
• Progress Tracking (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Consent Verification (Soft Skills)
• Document Management (Hard Skills)
• Effective Communication (Soft Skills)

Job Summary:

• Responsible for manual data abstraction to support program initiatives.
• Directly obtains clinical performance information, including quality and efficiency.
• Evaluates and interprets analyses and provides summary reports.
• Effectively communicates findings with team leaders.
• Identifies and compiles data from multiple sources to produce requested analysis to support improvement initiatives.
• Measures changes and trends.
• Works closely with all levels of staff to determine analytic and reporting needs and ensures that requested information is created accurately and in a timely manner.
• Reports assigned project progress and activity 
• Maintains communication with team member(s) and leadership.
• Attends and participates in appropriate workgroups and teams as directed.
• Develops and maintains expertise in the data systems utilized to support improvement initiatives.
• Works with the Research team in assisting completion of follow up care, documentation and reporting requirements.

Skills on Resume:

• Data Abstraction (Hard Skills)
• Performance Analysis (Hard Skills)
• Report Generation (Hard Skills)
• Effective Communication (Soft Skills)
• Data Compilation (Hard Skills)
• Trend Measurement (Hard Skills)
• Analytical Coordination (Soft Skills)
• Research Assistance (Hard Skills)

Job Summary:

• Support of study processes involving some tasks from execution through completion of studies, data entry, data tabulation and the creation of scientific manuscripts or abstracts.
• Assist in preparation of templates, case report forms, manuals, and guidelines for clinical studies.
• Assist with maintaining Trial Master File structure according to standard GCP policies and regulatory guidance.
• QC of study data to ensure its integrity and accuracy.
• Collaborate on study execution & documentation including but not limited to Protocol, CRF, ICF, SIV, Study tools as well as Source and Regulatory documentation 
• Verify appropriate reporting and documentation of adverse events and protocol deviations per internal and protocol requirements.
• Assist Monitors with clinical investigations, including protocol compliance, subject welfare and data integrity.
• Perform scientific literature searches.
• Collaborate with and be part of a motivated team to maximize productivity and efficiency.

Skills on Resume:

• Study Support (Hard Skills)
• Template Preparation (Hard Skills)
• File Management (Hard Skills)
• Data Quality Control (Hard Skills)
• Study Documentation (Hard Skills)
• Compliance Verification (Hard Skills)
• Clinical Assistance (Hard Skills)
• Literature Research (Hard Skills)

Job Summary:

• Handle clinical data collection activities on-site including seeking informed patient consent, monitoring enrollment, and preparing and maintaining compliance documents.
• Handle clinical data management on-site including maintaining essential documentation necessary for clinical studies, data curation, and data transfer.
• Assess data quality and integrity, and prepare data management reports.
• Ensure collected clinical data is entered in the database in a timely manner, and extract data as required for analysis and reporting purposes.
• Support the company’s Clinical Data Engineering and Research Teams in data engineering activities such as data sorting, data review, and dataset preparation.
• Facilitate the development and validation of the company’s flagship AI technologies.
• Support the company’s Regulatory Affairs and Quality Assurance in essential documentation pertaining to clinical data management
• Provide consultative support to Senior Management within the context of the overall strategic objective 

Skills on Resume:

• Data Collection (Hard Skills)
• Document Maintenance (Hard Skills)
• Data Integrity Assessment (Hard Skills)
• Database Management (Hard Skills)
• Data Engineering Support (Hard Skills)
• AI Technology Validation (Hard Skills)
• Regulatory Documentation (Hard Skills)
• Strategic Consultation (Soft Skills)

Job Summary:

• Serve as a critical resource and subject matter expert, supporting clinical data projects.
• Act as an expert for all electronic medical information and non-claims data quality reporting
• Identify opportunities where data is missing or being under-reported.
• Educate and lead other areas to improve their processes for capturing and using data.
• Interface with Business, Analytics, and IT teams.
• Provide assistance to ensure data integrity and data quality.
• Provide guidance to Vendor, IT teams, Provider Relations, and providers as the subject matter expert for all provider engagement in HL7 file transmissions.
• Ensure that all EMR data is appropriately received by Vendor and forwarded to the client.
• Oversee reporting, monitoring, and evaluation activities of provider participation in clinical data submissions.
• Improve member outcomes, customer experience, and operational efficiencies.
• Understand "big picture" outcomes from clinical data that may be used by a number of teams including Risk Adjustment, Care Management programs, Population Health Analytics, value-based programs, HEDIS, and Stars reporting.

Skills on Resume:

• Data Expertise (Hard Skills)
• Quality Oversight (Hard Skills)
• Process Leadership (Soft Skills)
• Team Collaboration (Soft Skills)
• Data Integrity (Hard Skills)
• HL7 Guidance (Hard Skills)
• Reporting Oversight (Hard Skills)
• Strategic Analysis (Hard Skills)

Job Summary:

• Accurate submission of study data to sponsors, federally mandated data reporting and/or data entry and maintenance of internal quality database for program evaluation.
• Directly abstracts patient data from the EMR and is responsible for requesting patient records from outside institutions.
• Utilizes templates and maintains accurate research and compliance records, transfers source documentation into CRF.
• Assists study team members with the preparation for monitor visits, supporting monitor visits, data audits and data locks.
• Works with study team members to plan, organize, and assist with patient study enrollment and ongoing scheduling of study visits.
• Maintains good communication and works closely with sponsors, submits data to them in a timely manner, meeting deadlines.
• Following up on any pending data and/or sponsor queries post submission and facilitating responses/resolution.
• Accurately documents all submissions and correspondence in a timely manner.
• Create source binders for enrolled patients to retain study records/source documentation and maintains/organizes data verification.
• Plans organize and assists with patient study eligibility, registration and enrollment.
• Requests and uploads scan to sponsors for review at disease assessment time-points.
• Collects, monitors, and maintains adverse events and related medications from time of consent to completion of the study.
• Accountable for serious adverse event reporting to sponsors including initial and follow-up reports.

Skills on Resume:

• Data Submission (Hard Skills)
• Data Abstraction (Hard Skills)
• Record Maintenance (Hard Skills)
• Audit Support (Hard Skills)
• Patient Coordination (Soft Skills)
• Sponsor Communication (Soft Skills)
• Query Resolution (Hard Skills)
• Adverse Event Tracking (Hard Skills)

Job Summary:

• Responsible for accurately capturing research data for scientific study and validation
• Liaise with research team in order to accurately collect and report data
• Design, test, implement, and manage clinical data collection and reporting systems
• Create, review, and file all data management documentation, such as Data Management Plans, Study Build Specifications, CRF Completion Guidelines
• Implement study-specific procedures that comply with regulatory and internal procedures
• Provide accurate data acquisition and furnish accurate and well-documented study databases to the statistical and clinical teams.
• Initiating the purchase of CRF's, diaries, and related documents from clinical protocols
• Preparing the study database dictionary, developing quality assurance database checks.

Skills on Resume:

• Data Capture (Hard Skills)
• Team Collaboration (Soft Skills)
• System Design (Hard Skills)
• Documentation Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Data Acquisition (Hard Skills)
• CRF Procurement (Hard Skills)
• Database Quality (Hard Skills)