Clinical Research Data Entry Specialist - East Melbourne
The Clinical Research Data Entry Specialist is responsible for accurately entering, managing, and maintaining clinical trial data in compliance with regulatory standards and study protocols. This role supports the research team by ensuring data integrity, timely documentation, and adherence to Good Clinical Practice (GCP) guidelines.
Responsibilities
- Enter clinical trial data into electronic data capture (EDC) systems and databases with precision and attention to detail.
- Review source documents and case report forms (CRFs) for completeness and accuracy.
- Perform data validation and query resolution in collaboration with study coordinators and investigators.
- Maintain confidentiality and security of patient and study information.
- Assist in the preparation of reports, summaries, and documentation for audits and monitoring visits.
- Track data entry progress and ensure timelines are met for data submission.
- Support data cleaning activities and contribute to database lock processes.
- Communicate effectively with clinical research staff to clarify data discrepancies.
- Follow standard operating procedures (SOPs) and regulatory requirements including FDA, ICH-GCP, and HIPAA.
Qualifications
- High school diploma or equivalent required; associate or bachelor’s degree in health sciences, life sciences, or related field preferred.
- Minimum of 1–2 years of experience in clinical research or data entry, preferably in a healthcare or academic setting.
- Familiarity with clinical trial documentation and EDC systems (e.g., REDCap, Medidata, OpenClinica).
- Robust organizational skills and attention to detail.
- Ability to work independently and manage multiple tasks under tight deadlines.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
- Understanding of medical terminology and clinical research processes is a plus.
Duration
3 month contract
Salary
Attractive salary + benefits
Location
Candidates to be office based in East Melbourne
Equal Opportunities Statement
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
To Apply
Please contact Sam Chapple (Associate Director, Recruitment - APAC) at Planet Pharma for more information:
T: +61 (0)
LinkedIn:
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