Verified Job
Work from home
Data Coordinator
Work from home
#669664
Remote / WFH
Job Description
JOB SUMMARY
The Data Coordinator manages core lab data (e.g. PSG, ECG, etc.) relating to various studies.
RESPONSIBILITIES
Provide support and act as the point person to the Sponsor, CROs, vendors, clinical sites, and scorers for questions regarding core lab data management
Develop and maintain good communications and working relationships with Clinilabs project team members as well as Sponsor, CRO, vendor, and clinical site project team members
Manage and track project timelines and quality issues
Assist in the development of study-specific SOPs
Assist in with certifying (e.g. PSG certification) study sites and tracking in the certification database
Assist with reliability management (PSG) assignments and tracking in the reliability database
Evaluate and analyze data submitted by various parties to ensure it meets the criteria set by the study protocol
Monitor and update study database to ensure that all data is being processed in a timely manner
Perform data entry and data QC
Perform query generation and tracking and oversee query resolution
File and store documents according to protocol
Track study progress and issue periodic status reports as needed
Assist in the creation and documentation of new or revised data management, IT and quality assurance procedures
Communicate with all operational departments regarding project status/issues
Follow and ensure compliance with current Good Clinical Practices (cGCPs)
Adhere to corporate policies and procedures
Other duties as assigned
TRAVELING
Travel as needed.
Requirements:
The position requires no experience or technical degree with at least 1 year of data coordination experience. No degree required though strongly preferred.
Strong computer (Microsoft Windows and Office Applications) and communication (oral and written) skills are required.
Must have detailed documentation and project management skills.
The Data Coordinator manages core lab data (e.g. PSG, ECG, etc.) relating to various studies.
RESPONSIBILITIES
Provide support and act as the point person to the Sponsor, CROs, vendors, clinical sites, and scorers for questions regarding core lab data management
Develop and maintain good communications and working relationships with Clinilabs project team members as well as Sponsor, CRO, vendor, and clinical site project team members
Manage and track project timelines and quality issues
Assist in the development of study-specific SOPs
Assist in with certifying (e.g. PSG certification) study sites and tracking in the certification database
Assist with reliability management (PSG) assignments and tracking in the reliability database
Evaluate and analyze data submitted by various parties to ensure it meets the criteria set by the study protocol
Monitor and update study database to ensure that all data is being processed in a timely manner
Perform data entry and data QC
Perform query generation and tracking and oversee query resolution
File and store documents according to protocol
Track study progress and issue periodic status reports as needed
Assist in the creation and documentation of new or revised data management, IT and quality assurance procedures
Communicate with all operational departments regarding project status/issues
Follow and ensure compliance with current Good Clinical Practices (cGCPs)
Adhere to corporate policies and procedures
Other duties as assigned
TRAVELING
Travel as needed.
Requirements:
The position requires no experience or technical degree with at least 1 year of data coordination experience. No degree required though strongly preferred.
Strong computer (Microsoft Windows and Office Applications) and communication (oral and written) skills are required.
Must have detailed documentation and project management skills.
