Safety Data Coordinator 2

PRA Health Sciences
Full time
Administrative
United States
Hiring from: Anywhere

Safety Data Coordinator 2



  • Job Locations(All) | US-Remote

  • ID: 2020-71253


Overview


Leads the development and implementation of medical coding in clinical data management systems; participates in management of individual case safety reports (SAEs, AEs of Special Interest, Adverse Drug Reactions), AE/SAE reconciliation and data retrievals from the clinical and/or safety databases; provides support for endpoint adjudication committees.


Responsibilities



  • Performs consistent coding of adverse events, medical history, concomitant medications and other terms according to the project-specific coding conventions.

  • Reconciles SAE/AE between clinical and safety database in accordance with the SAE/AE reconciliation plan and other project-specific guidelines.

  • Generates DCFs (Data Clarification Forms) or queries, performs corrections of CRFs, if applicable, and clinical databases in accordance with DCF replies.

  • Receives and tracks serious adverse events, adverse events of special interest, and adverse drug reactions reports and forwards them to the sponsor/third party in accordance with project-specific contractual agreement.

  • Performs data entry of minimal SAE/ADR data in company’s or sponsor’s safety database.

  • Queries site or reporter for inconsistent or incomplete information on SAE/ADR report.

  • Maintains address lists for submission of safety reports to investigators and EC/IRBs.

  • Tracks submission of safety reports to investigators and EC/IRBs in company’s Safety Letter Tracking System.

  • Conducts quality review of endpoint dossiers/adjudication forms adhering to the agreed timelines.

  • Tracks and reconciles endpoint dossiers/adjudication forms.

  • Queries sites for missing or inconsistent information on endpoint dossiers/adjudication forms.

  • Interacts with endpoint committee during endpoint review.

  • Properly documents all internal and external contacts and communications.

  • Consistently meets or exceeds objectives set annually.

  • Ensures personal career goals are set each year and progress is monitored for completion

  • Performs consistent coding of adverse events, medical history, concomitant medications and other terms according to the project-specific coding conventions.

  • Reconciles SAE/AE between clinical and safety database in accordance with the SAE/AE reconciliation plan and other project-specific guidelines.

  • Generates DCFs (Data Clarification Forms) or queries, performs corrections of CRFs, if applicable, and clinical databases in accordance with DCF replies.

  • Receives and tracks serious adverse events, adverse events of special interest, and adverse drug reactions reports and forwards them to the sponsor/third party in accordance with project-specific contractual agreement.

  • Performs data entry of minimal SAE/ADR data in company’s or sponsor’s safety database.

  • Queries site or reporter for inconsistent or incomplete information on SAE/ADR report.

  • Maintains address lists for submission of safety reports to investigators and EC/IRBs.

  • Tracks submission of safety reports to investigators and EC/IRBs in company’s Safety Letter Tracking System.

  • Conducts quality review of endpoint dossiers/adjudication forms adhering to the agreed timelines.

  • Tracks and reconciles endpoint dossiers/adjudication forms.

  • Queries sites for missing or inconsistent information on endpoint dossiers/adjudication forms.

  • Interacts with endpoint committee during endpoint review.

  • Properly documents all internal and external contacts and communications.Consistently meets or exceeds objectives set annually.

  • Ensures personal career goals are set each year and progress is monitored for completion.

  • Responsible for effective and efficient development of the coding conventions and coding dictionary license confirmation forms.

  • Manages quality control review of coded data.

  • Responsible for effective and efficient development of the SAE/AE reconciliation plan.

  • Performs quality control of minimal data entry of safety data into company’s or sponsor’s safety database.

  • Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.

  • Participates in internal and client meetings.

  • Reports project status to project/functional management.

  • Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.


Qualifications



  • Undergraduate degree or its international equivalent, preferably in life science and/or healthcare professional.

  • Read, write and speak English; fluent in host country language required.

  • Previous experience using computerized information systems and standard application software (Windows, MS Office).

  • Good written and oral communication skills.

  • 3 Years Data Management or Health information Management experience required


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