Data Capture / Data Entry Officer (2)

Job Title: Data Capturer / Data Entry Officer (2) Location: Rachuonyo, Homabay County Reports To: Data Manager / Study Coordinator/PI Position Type: Full-time, Contract Job Purpose: He/she is responsible for timely and accurate entry of clinical trial data into electronic data capture (EDC) systems in accordance with Good Clinical Practice (GCP) guidelines and the study protocol.

The officer will ensure data integrity and completeness by reviewing source documents, resolving discrepancies, and collaborating closely with the clinical and quality assurance teams.

Key Responsibilities: Accurately enter clinical and laboratory data from case report forms (CRFs) and source documents into the EDC system within specified timelines.

Conduct daily reviews to ensure data entered is complete, consistent, and within acceptable query limits.

Perform double data entry and validation checks where required to minimize errors.

Flag and escalate any data inconsistencies or missing information to the clinical team for resolution.

Maintain organized filing of source documents, CRFs, visit logs, and study binders.

Ensure all data management documentation is securely stored and backed up according to study SOPs.

Maintain logs of data entry, queries raised, and responses provided.

Review data queries generated by the study monitor or data manager and assist with resolving them promptly.

Liaise with study staff (e.g., study nurses, clinicians) to clarify or verify data discrepancies.

Participate in regular internal data quality reviews and monitoring visits.

Support efforts to ensure compliance with protocol, SOPs, GCP, and regulatory guidelines.

Report issues related to data quality or process challenges to the Data Manager or Coordinator.

Work closely with other data team members and clinical staff to ensure high data standards are maintained.

Participate in regular team meetings and training on data handling and confidentiality.

Qualifications & Experience: Diploma or Bachelor’s degree in Information Technology, Health Records, Statistics Prior experience in clinical trial data entry or health records management is strongly preferred.

Familiarity with EDC systems (e.g., Medidata Rave, REDCap) is an added advantage.

Understanding of clinical research documentation and terminology.

Skills and Attributes: Fast and accurate typing and data entry skills.

Excellent attention to detail and ability to detect inconsistencies or errors.

Strong organizational and time management skills.

Proficiency in computer applications such as MS Word, Excel, and familiarity with EDC platforms (e.g., REDCap, Medidata Rave). High level of integrity and commitment to maintaining confidentiality of sensitive participant data.

Ability to work independently and collaboratively within a multidisciplinary team.

Strong communication and interpersonal skills to facilitate coordination with clinical and QA teams.

Cultural sensitivity and ability to work effectively with diverse community and study populations.

Ability to follow protocols, SOPs, and regulatory requirements consistently.

Working Conditions: Full-time position based at the study site, with occasional extended hours to meet data entry deadlines.

Work is primarily office-based, requiring sustained computer use and focus for long periods.

May involve sitting for extended periods during data entry or documentation tasks.

Requires handling of confidential participant records in compliance with GCP and institutional data protection policies.

May occasionally require presence during participant visits to verify real-time data or assist with source documentation checks.

Participation in regular internal audits, monitoring visits, and data reviews is expected.

Applications must include the following: Application letter, Complete CV with 2 referees indicating their telephone contacts and e-mail contacts Relevant certificates and testimonials If qualified for the above post, please send your application addressed to the Principal Investigator, MK8527 Study.

If qualified for the above post, please send the above documents to the email by 27/7/2025 NB: Applications without the above-mentioned qualifications or required certificates will NOT be considered.

Only shortlisted candidates will be contacted.

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