Data Coordinator (EDC)

Alcanza Clinical Research

Responsibilities

works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs.
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

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.

: High School diploma or equivalent and a minimum of 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, 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.

Skills, Knowledge and Expertise

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.