Job Description
Job DetailsJob 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).
Qualifications
