Central Clinical Data Coordinator II

A Central Clinical Data Coordinator II works to coordinate and implement data collection for various studies, focusing on the day-to-day operations including, monitoring the completion of project-related tasks, maintaining study-related procedures to ensure protocol and regulatory compliance.

DUTIES & RESPONSIBILITIES

• Transcribe and manage data for assigned clinical studies
• Maintain training & working knowledge of current FDA GCP/ICH guidelines, organizational SOPs, guidance documents,work instructions, and study protocols.
• Ensure the quality and timeliness of data transcribed for assigned studies within appropriate reporting requirements.
• Contribute towards ensuring internal processes are in accordance study requirements
• Participate in training new Clinical Data team members.
• Resolve any discrepancies, queries and and other study-related abnormalities in-line with company and study protocols
• Complete eDiary functions
• Adequately document and report on clinical trial progress as per applicable requirements
• Contribute to, and/or generate requested reports for management
• Participate in trainings and meetings as required
• Submitting required administrative paperwork per company timelines
• Perform quality checks as required by Clinical Data management
• Any other matters as assigned by management pertinent to trial related functions.

KNOWLEDGE & EXPERIENCE

Education:

• Associate degree preferred
• Bachelor’s Degree required

Experience:

• Experience with medical terminology is a plus
• 1+ years experience with clinical research is required

Credentials:

• N/A

Knowledge and Skills:

• Strong knowledge of Google Suite products, Clinical Databases and other computer-related software
• Excellent oral and written communication skills
• Excellent planning and organizational skills with effective time management • Excellent interpersonal skills
• Meticulous, independent, and capable of working with minimal supervision
• Excellent data handling and analysis
• Problem-solving skills
• Thorough understanding of clinical research principles and processes. Ability to input into process initiatives, and procedures related to Good Clinical Practices (GCP).