Clinical Data Coordinator

Clinical Data Coordinator  

Permanent - Full Time

Purpose of the Role

• The purpose of this role is to accurately transcribe source data from subject workbooks to case report forms (CRFs), review records to identify and resolve queries, and participate in the quality control (QC) process.


• Accurately transcribe source data from subject workbooks to the sponsor-supplied Electronic Data Capture (EDC) system. Review records for queries/missing data, maintain a query log, and liaise with clinical staff to ensure data accuracy. Adhere to data entry and query resolution timelines, evaluate data comprehensively to identify less obvious queries, and collaborate with the team to meet data entry deadlines. Provide QC of team members' data entry, address discrepancies, and assist in monitoring visits.

Responsibilities

• Accurately transcribes source data from subject workbooks to the sponsor supplied EDC system.


• Reviews relevant fields in subject workbooks for queries/missing data and completes a running query log. Liaises with clinical staff (doctors, nurses etc.) and other appropriate study staff identified on the queries log to clarify data, thus ensuring data accuracy. 


• Ensure EDC is current per EDC guidelines/protocol. Reports inconsistencies with EDC to sponsor/CRO via SC (Study Coordinator).


• Adheres to data entry timelines and query resolution timelines.


• Evaluates data as a whole in order to identify less obvious data queries.


• Works closely with team to ensure data entry timelines met for all studies.


• Supports team to enter workload into data entry calendar.


• Communicates any issues identified to SC in a timely manner. 


• Reviews and in collaboration with the SC organize resolution of queries in EDC, adds to the queries log and follows up, as necessary.


• Provides QC of team members data entry as required (includes spot checks). Reports QC findings to Quality Dept. as required.


• Reviews discrepancy reports generated by Sponsor Data Management teams as directed by the SCTL/SCs.


• Works with SCTL/SC to address action items related to data in Monitoring Visits Letters.


• Reports inconsistencies to SCTL/SC and liaises with Clinical Research Associates (CRAs) during monitoring visits as required.


• Assists SCTL/SC/ASC to provide workbooks to CRA as required.


• Attends Study Initiation Visit (SIV) as required.


• Ensures training related to protocol and EDC guideline always current.


• Ensures is on the Delegation Log for all relevant studies.


• Liaises with local/central lab with regards to:


• Requesting lab reports


• Inconsistencies in lab reports.

Minimum Position Qualifications

Education:     Tertiary degree in a science-based discipline or working towards such a degree

Experience:   Preferred experience demonstrating attention to detail and scientific understanding.

Knowledge, Skills, and Abilities

• Meticulous attention to detail


• Good knowledge of science and medical terminology


• Ability to foster a cooperative work environment. 


• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.


• Ability and desire to seek, respond to and provide critique for continuous improvement of self and colleagues. 


• Skill in the use of a networked computer and Microsoft office applications