Coordinator, Edc

2 days ago

Hyderabad Telangana, India Velocity Clinical Research, Inc. Full time

Overview:
Job Summary:
This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity.

**Responsibilities**:
Duties/Responsibilities:

- Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality.
- Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations.
- Monitor data discrepancies, perform data cleaning activities
- Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security.
- Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams.
- Other duties as assigned

Qualifications:
Required Skills/Abilities:

- Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements.
- Excellent analytical skills and attention to detail to ensure data accuracy and compliance.
- Ability to work independently and collaboratively in a fast-paced clinical research setting.

Education and Experience:

- Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred.
- Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus.
- Experience: 1-2 years of experience in clinical research, healthcare, or laboratory settings.

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