Data Coordinator (EDC)

Alcanza Clinical Research•Decatur, GA

About The Position

The Data Coordinator (EDC) works to ensure assigned clinical studies are executed in compliance with GCP, ICH, HIPAA, FDA regulations, and standard operating procedures. Working with other clinical research site team members, the coordinator supports entry of clinical visit data in EDC and other clinical data software and systems. The role also supports other clinical research activities and protects confidential patient, customer, and company information.

Requirements

High school diploma or equivalent, and at least 1 year of clinical data entry experience, or an equivalent combination of education and experience.
Proficiency with computer applications such as Microsoft applications, email, and web applications.
Ability to type proficiently at 40+ words per minute.
Strong organizational skills and attention to detail.
Well-developed written and verbal communication skills.
Well-developed interpersonal and listening skills, and ability to work well independently and with coworkers, subjects, managers, and external customers.
Ability to handle multiple tasks effectively and adapt to changes in workload and priorities.
Professional, respectful, self-motivated, and strong work ethic.
High degree of integrity and dependability.
Ability to handle highly sensitive information confidentially and professionally, in compliance with HIPAA guidelines.

Responsibilities

Enter clinical trial data, including patient data, into EDC and other software systems.
Review patient charts and other medical records to ensure data is entered promptly and in accordance with eCRF guidelines and protocol requirements.
Report study irregularities or problems to appropriate parties.
Support other clinical research-related activities.
Ensure compliance with SOPs, regulations, ICF documentation, and GCP/GDP guidelines.
Maintain confidentiality of patient, customer, and company information.
Perform other related activities as assigned.