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Data Entry Coordinator
2 months ago
The Data Entry Coordinator works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs.
Key ResponsibilitiesEssential Job Duties:
In collaboration with other members of the clinical research site teamwork to ensure the entry of clinical visit data in EDC and other clinical data software/systems. Responsibilities may include but are not limited to:
- Managing data entry into computer systems for clinical trials, including entering patient data into eDC and other software
- Reviewing patient charts and other medical records to ensure data is entered in a timely manner in accordance with eCRF guidelines and protocol requirements
- Reporting any irregularities or problems with a study to the appropriate parties
- Supporting other clinical research-related activities
- Ensuring compliance with SOPs, regulations, ICF documentation, and GCP/GDP guidelines
- Maintaining confidentiality of patients, customers, and company information, and performing other related activities as assigned.
Skills, Knowledge and ExpertiseMinimum Qualifications: High School diploma or equivalent and a minimum of 1 year of clinical data entry experience, or an equivalent combination of education and experience.
Required Skills:
- Proficiency with computer applications such as Microsoft applications, email, and web applications, and the ability to type proficiently (40+ wpm);
- Strong organizational skills and attention to detail.
- Well-developed written and verbal communication skills.
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
- Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess a high degree of integrity and dependability.
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits
- Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
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