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Private Jobs / Private Sector
Labcorp Hiring for Document Coord Metabolism at Bengaluru, Karnataka Full Time
Full Job Description
Performs initial review of analytical data and originates noncompartmental analysis in support of pharmacokinetic and toxicokinetic studies.
Reviews study compliance against protocol, SOP and regulatory agency guidelines
Prepares study schedules based on input from Study Director (SD)/Principal Investigator (PI), places information into databases and communicates work plan to laboratory personnel and support groups, as applicable.
Participates in and assists SD/PI with pre-initiation and other study related meetings as required.
Reviews progress and study status against initial work plan – maintains CMS with accurate schedules.
Proactively communicates and interacts with study team to ensure key milestones are achieved.
Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence.
Assists SD/PI in the PK/TK study phase, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines.
Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.
Assists in the development and maintenance of standard report/table formats as required.
Assists in interpreting and evaluating data for reports.
Reviews QAU report audits with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.
Reviews client comments and makes decisions in conjunction with SD/PI and ensures that all necessary report/raw data clarifications are completed.
Responsible for and drives report production through finalization, including archiving of data as appropriate.
Develops an area of expertise within the department and serves as a resource by providing training and written instructions.
Performs other related duties as assigned.
Reviews study compliance against protocol, SOP and regulatory agency guidelines
Prepares study schedules based on input from Study Director (SD)/Principal Investigator (PI), places information into databases and communicates work plan to laboratory personnel and support groups, as applicable.
Participates in and assists SD/PI with pre-initiation and other study related meetings as required.
Reviews progress and study status against initial work plan – maintains CMS with accurate schedules.
Proactively communicates and interacts with study team to ensure key milestones are achieved.
Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence.
Assists SD/PI in the PK/TK study phase, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines.
Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.
Assists in the development and maintenance of standard report/table formats as required.
Assists in interpreting and evaluating data for reports.
Reviews QAU report audits with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.
Reviews client comments and makes decisions in conjunction with SD/PI and ensures that all necessary report/raw data clarifications are completed.
Responsible for and drives report production through finalization, including archiving of data as appropriate.
Develops an area of expertise within the department and serves as a resource by providing training and written instructions.
Performs other related duties as assigned.
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