Assistent/in - klinische Studien

Identification of data discrepancies via computerized edit checks and manual data checks.
Study Status & DM Reports
Comprehensive Data review by using SAS Dataset/output or Listing/Reports
Auto-queries- handled solely and mentored & trained resources on this activity.
Study documentations & maintaining binders.
Ensure that all steps prior to locking the database are complete, utilizing a CDM check list
Patient/ Visit/ Forms Locking activity at Interim & Final Database Lock
Daily review for data accuracy and consistency.
Perform all clinical data management activities on assigned projects.
Key activities include data validation, generation and resolving of queries, reconciliation of safety and Vendor data and updating trackers on ongoing basis.
Work to the appropriate standards of quality and efficiency and follow up with the issues till resolution.

Daily review for data accuracy and consistency.
Verify site data entry according to schedule
Issue queries / discrepancies and close queries; create / send discrepancy notifications to sites
Generate manual queries based upon findings from the listings and reports
Manage data review and cleaning timelines
Process new data / discrepancies from all studies in a first in, first out model
Complete DB ‘pre-lock’ checklist; verify that all queries have been received from the sites and resolved
Reconciliation of all vendor data with clinical data base

Identification of data discrepancies via computerized edit checks and manual data checks.
Study Status & DM Reports
Comprehensive Data review by using SAS Dataset/output or Listing/Reports
Auto-queries- handled solely and mentored & trained resources on this activity.
Study documentations & maintaining binders.
Ensure that all steps prior to locking the database are complete, utilizing a CDM check list
Patient/ Visit/ Forms Locking activity at Interim & Final Database Lock
Daily review for data accuracy and consistency.
Perform all clinical data management activities on assigned projects.
Key activities include data validation, generation and resolving of queries, reconciliation of safety and Vendor data and updating trackers on ongoing basis.
Work to the appropriate standards of quality and efficiency and follow up with the issues till resolution.
Understand and comply with core procedures and working instructions.
Develop and maintain good communications and working relationships with CDM team

Managing the daily activities of research study and to conduct the study which is compliance with the protocol federal regulations & institutional policies
Reviewing the subject eligibility requirements, recruiting the subjects and conducting the visits.
Scheduling the subject visits to ensure 100% subject compliance and safety.
Administering the informed consent and conducting the informed consent process
Ensuring that projected laboratory procedures are conducted according to the SOPs.
Coordinating all activities related to shipping samples to labs courier services.
Documenting all records in written, electronic, magnetic and optical records, scans, X-rays and ECGs to meet ICH GCP guidelines.
Filling the source data into the Case Report Form.
Reviewing the CRF entries preparing the documents for the monitoring as well as Auditing as per the ICH GCP Guidelines, Maintaining all study related logs.
Working with monitor during monitoring visits, Reporting SAE’s
Assistance in resolving all queries that the monitor may bring to attention.
Making sure that protocol, IB, Informed consent form and other trial related documents and their amendments are reviewed and approved by ethics committee.
Adhered to strict project time lines.

Managing the daily activities of research study and to conduct the study which is compliance with the protocol federal regulations & institutional policies
Reviewing the subject eligibility requirements, recruiting the subjects and conducting the visits.
Scheduling the subject visits to ensure 100% subject compliance and safety.
Administering the informed consent and conducting the informed consent process
Ensuring that projected laboratory procedures are conducted according to the SOPs.
Coordinating all activities related to shipping samples to labs courier services.
Documenting all records in written, electronic, magnetic and optical records, scans, X-rays and ECGs to meet ICH GCP guidelines.
Filling the source data into the Case Report Form.
Reviewing the CRF entries preparing the documents for the monitoring as well as Auditing as per the ICH GCP Guidelines, Maintaining all study related logs.
Working with monitor during monitoring visits, Reporting SAE’s
Assistance in resolving all queries that the monitor may bring to attention.
Making sure that protocol, IB, Informed consent form and other trial related documents and their amendments are reviewed and approved by ethics committee.
Adhered to strict project time lines.

Preparing presentations for the clinical trial sites on GCP
Assisting in preparation of the SOPs

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