Overview
If you're interested in data entry, this could be the job for you! Join our dynamic clinical research team as a Clinical Research Assistant - EDC Entry Specialist, to support Phase II-III clinical trials. In this vital role, you will be responsible for meticulous data entry into Electronic Data Capture (EDC) systems, ensuring accuracy and compliance with regulatory standards. Your energetic approach and attention to detail will support the advancement of healthcare research, contributing to life-changing treatments and therapies. This paid position offers a unique opportunity to develop your skills within a collaborative, research-focused environment dedicated to excellence in clinical development.
Duties
- Accurately input and manage clinical trial data within EDC systems,
- Review source documents and case report forms (CRFs) for completeness and consistency before data entry
- Monitor data quality by performing regular audits and resolving discrepancies in collaboration with study coordinators and investigators
- Assist in maintaining compliance with FDA regulations, ICH GCP guidelines, and HIPAA privacy standards throughout all data management activities
- Assist with subject visits as needed
- Review documentation related to patient monitoring, laboratory results, and adverse events to ensure accuracy and regulatory adherence
- Contribute to research project management by tracking data timelines, documenting protocol deviations, and preparing reports for review
Qualifications
- Prefer experience in clinical research
- Strong knowledge of medical terminology, clinical laboratory procedures, phlebotomy, blood sampling, and vital signs measurement
- Demonstrated experience with EDC systems (e.g, REDCap, Oracle InForm, Medidata Rave, or similar)
- Demonstrated understanding of FDA regulations, ICH GCP guidelines, healthcare compliance standards including HIPAA privacy rules
- Strong attention to detail and commitment to data accuracy and quality
- Excellent analysis skills with attention to detail; ability to review complex documentation accurately while maintaining compliance standards
- Effective communication skills for collaboration across multidisciplinary teams involved in clinical development projects
Join us in advancing healthcare through meticulous research support! Your dedication will help shape the future of medicine while developing valuable skills in a fast-paced research environment. This paid role offers growth opportunities for those passionate about clinical research, data management, and improving patient outcomes.
Pay: $18.00 - $22.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Flexible spending account
- Health insurance
- Paid time off
Work Location: In person
