Tampa General Hospital
Clinical Research Data Coordinator - TGH Cancer Institute
Tampa General Hospital, Tampa, Florida, us, 33646
The Clinical Research Data Coordinator I manages the data for assigned research studies. This will include, designing forms for data collection, clinical data abstraction, reconciling data, maintaining record systems, and producing project reports for studies. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the data coordinator plays a critical role in the study by reviewing, extracting, cleaning, and auditing data from various source documents so that the appropriate data can be shared.
Scope :
• Data collection, abstraction and entry
• Report production
• Audit data, reconcile inconsistencies and resolve querie
• Test databases during development
• Develops data collection tools and designs form
• Process improvement for data accuracy & departmental project
SUMMARY OF RESPONSIBILITIES
1. Collects and records study data from various source documents into different case report systems. Inputs all information accurately into database
2. Maintains source documents and subject files in accordance with hospital procedures.
3. Reviews and audits database on a regular basis to ensure accuracy of data.
4. Makes corrections and additions to database records as required.
5. Ensures accurate and complete compilation of subject data through chart reviews.
The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. The Data Coordinator I is responsible for performing job duties in accordance with the mission, vision, and values of the CCRO and Tampa General Hospital.
Qualifications
Minimum Requirements
Preferred Requirements
Education:
• Associates Degree in science (or related field) Equivalency: HS/GED plus two years of related experience.
Education
Experience
• One (1) years of related experience
• Novice knowledge of applicable regulations (i.e., FDA, NIH, OHRP, etc.) and demonstrated ability to follow regulations, policies and procedures.
• Demonstrated ability to exercise sound judgement
• Intermediate proficiency in Microsoft Office
Experience
• Two (2) years of direct clinical research experience or oncology experience (or any combination thereof)
• Working knowledge of Good Clinical Practice guidelines and Code of Federal regulations.
• Oncologic terminology
Licensure, Certification, Registration
• Good clinical practice certification within three (3) months of hire
Licensure, Certification, Registration
Language Skills
Read and Write English
Language Skills
Certified interpreter in additional language
While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the data coordinator plays a critical role in the study by reviewing, extracting, cleaning, and auditing data from various source documents so that the appropriate data can be shared.
Scope :
• Data collection, abstraction and entry
• Report production
• Audit data, reconcile inconsistencies and resolve querie
• Test databases during development
• Develops data collection tools and designs form
• Process improvement for data accuracy & departmental project
SUMMARY OF RESPONSIBILITIES
1. Collects and records study data from various source documents into different case report systems. Inputs all information accurately into database
2. Maintains source documents and subject files in accordance with hospital procedures.
3. Reviews and audits database on a regular basis to ensure accuracy of data.
4. Makes corrections and additions to database records as required.
5. Ensures accurate and complete compilation of subject data through chart reviews.
The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. The Data Coordinator I is responsible for performing job duties in accordance with the mission, vision, and values of the CCRO and Tampa General Hospital.
Qualifications
Minimum Requirements
Preferred Requirements
Education:
• Associates Degree in science (or related field) Equivalency: HS/GED plus two years of related experience.
Education
Experience
• One (1) years of related experience
• Novice knowledge of applicable regulations (i.e., FDA, NIH, OHRP, etc.) and demonstrated ability to follow regulations, policies and procedures.
• Demonstrated ability to exercise sound judgement
• Intermediate proficiency in Microsoft Office
Experience
• Two (2) years of direct clinical research experience or oncology experience (or any combination thereof)
• Working knowledge of Good Clinical Practice guidelines and Code of Federal regulations.
• Oncologic terminology
Licensure, Certification, Registration
• Good clinical practice certification within three (3) months of hire
Licensure, Certification, Registration
Language Skills
Read and Write English
Language Skills
Certified interpreter in additional language