Job Description
Job Location: Corporate - Karachi (KHI) - Karachi, Sindh 75600A 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).