Data entry specialist

Description

Summary: This Data Entry Associate role involves confirming patient enrollment, verifying consent, entering eCRF data, addressing queries, and managing SAEs, ensuring data accuracy and compliance. Highlights: 1. Ensure accurate patient consent and enrollment verification 2. Manage eCRF data entry and address open queries 3. Identify, enter, and report safety data (SAEs) as per protocol **Key Responsibilities as Data Entry Associate:** · Confirm the number of enrolled/ongoing/discontinued patients and verify the enrolment log. · Review the latest ICF signatures for subjects with data entry during the visit to ensure proper consent. Check this at each visit to confirm ongoing consent. · Ensure the date of consent is entered in the eCRF for all patients who have consented. · Enter required data into the eCRF and address open queries. · Enter all unsubmitted SAEs from the SAE listing into the EDC. · Identify and enter unreported SAEs in the EDC and submit them as per protocol. · Address data entry issues with the Principal Investigator/Site Personnel. · Raise missing data with site staff, locate inpatient medical notes, and enter them into EDC, documenting details in the Data Collection Report. · Note and report any inconsistencies or deficiencies in subject source data to site staff, documenting in the DCR. · Enter unreported safety data (e.g., SAEs, medication details, lab abnormalities) into the EDC during the visit, documenting details in the DCR. · Record and report all SAEs/special events in the EDC. If this opportunity matches your skills and interest, we would be delighted to hear from you. Please send us: * Your updated CV. Job Type: Part\-time Pay: 12\.00€ \- 17\.00€ per hour Work Location: Hybrid remote in Guimarães