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Description:
Summarized Purpose:
Provides records management (RM) and file room support by working with project teams to ensure all records management tasks are completed according to organization and/or client standard operating procedures (SOP) and working practice documents (WPD).
Essential Functions:
Processes (scans/images, indexes, files) incoming study documents.
Assists study teams as required per SOP/WPD with filing of all documents for the trial master file (TMF) and case report form (CRF).
Liaises with the clinical study team to resolve outstanding issues identified during filing and quality reviews.
Provides technical support for the study team when initiating the TMF.
Performs transfer/archival or central archival related tasks.
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Associate's degree preferred
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Fundamental communication and interpersonal skills
Good organizational skills and strong attention to detail with ability to handle multiple tasks efficiently and effectively
Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
Flexibility to reprioritize workload to meet changing project timelines
Good computer skills
Excellent English and grammar skills, (second language a plus)
Description:
Summarized Purpose:
Provides records management (RM) and file room support by working with project teams to ensure all records management tasks are completed according to organization and/or client standard operating procedures (SOP) and working practice documents (WPD).
Essential Functions:
Processes (scans/images, indexes, files) incoming study documents.
Assists study teams as required per SOP/WPD with filing of all documents for the trial master file (TMF) and case report form (CRF).
Liaises with the clinical study team to resolve outstanding issues identified during filing and quality reviews.
Provides technical support for the study team when initiating the TMF.
Performs transfer/archival or central archival related tasks.
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Associate's degree preferred
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Fundamental communication and interpersonal skills
Good organizational skills and strong attention to detail with ability to handle multiple tasks efficiently and effectively
Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
Flexibility to reprioritize workload to meet changing project timelines
Good computer skills
Excellent English and grammar skills, (second language a plus)
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