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Study Coordinator

3 months ago

Bengaluru, Karnataka, India IEN Labcorp Early Development India Private Limited Full time

1. Data Analysis and Reporting : Performs initial review of bioanalytical data and originates noncompartmental analysis (NCA) using Phoenix WinNonlin in support of pharmacokinetic and toxicokinetic studies. Aids in report preparation, including tables and figures.

2. Study Conduct: Serves as the primary contact for communication and interaction with other departments and clients as applicable. Proactively communicates and interacts with study team (PI, SD's and operational staff) to ensure key milestones are achieved. Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence.

3. Study Monitoring and Regulatory Compliance: Assists SD/PI in monitoring in-life and analytical phases of studies, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines. Participates in and assists SD/PI with pre-initiation and other study related meetings as required.

4. Review and QC : Contribute to the peer review process for scientific reports, providing constructive feedback as appropriate. Assist in checking protocols, proofing tables and figures prepared by others, ensuring proficiency with data collection systems and preparation software. 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.

5. Study Phase Scheduling : Assist in scheduling study phases in coordination with the Study Director/Principal Investigator, Schedulers and Lab Operations.

6. Study Archival : Perform tasks related to study archival, including notifying necessary personnel of study finalization/archival and gathering required paper/electronic items for archival purposes.

7. Coordination with Team : Work closely with other Study Coordinators (SCs) and Analytical Coordinators (ACs), Document Coordinators (DCs) to assist in preparing, monitoring, maintaining, and understanding finalization/archival, scheduling mechanisms for studies.

8. Innovation : Develops new report/table formats as needed including client specific template formatting. Maintains and updates existing templates as necessary. Stay up-to-date with emerging trends and technologies to enhance efficiency and effectiveness.

9. Other Duties : Undertake additional responsibilities as assigned by management.

Requirements:

Master's degree in a related field with 5-8 years relevant experience. Strong attention to detail and organizational skills. Ability to learn and adapt quickly to new processes and procedures. Excellent communication skills, both written and verbal. Proficiency in Phoenix WinNonlin, Microsoft Office Suite and other relevant software applications. Ability to work collaboratively in a team environment. Prior experience in a laboratory or research setting preferred, but not required.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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