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Essential job duties:
¨ (20%) Data Planning – responsible for all data aspects of studies including review of draft protocols, attending Clinic Start Up Meetings, supporting the workbook (CRF) design process, training plans for non-standard study data capture and attend Biometrics start up meetings as required.
¨ (20%) Ensure that the data entry and QC of dose escalation data is completed within the required timelines.
¨ (15%) Complete daily ongoing QC of all study data across Clinical Operations including daily shop floor QC.
¨ (15%) Act as principle host for sponsor CRF monitoring visits. Promoting a professional image of Leeds CRU and building strong collaborative working relationships with CRA’s.
¨ (10%) Query Resolution – ensure all database queries; sponsors written data queries, CRA monitoring queries and internal QA audit findings are resolved within the agreed timelines.
¨ (10%) Responsible for ensuring the weekly Data Entry Schedule is updated and accurately reflects study workload.
¨ (5%) Study Close Down - Ensure completed CRF’s are signed by the Principal or Associate Investigator and that all CRF’s and source data is archived on completion of the study.
¨ (5%) Perform other job related duties as assigned.
Minimum requirements
Typically looking for 1-2 years of data handling experience. Experience can be from a clinical or non-clinical background. For example financial data handling background.
¨ Excellent written and oral communication skills
¨ Ability to prioritize workloads
¨ Good organizational skills
¨ Previous customer service experience desirable
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Job Type
Remote Status
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