Study Coordinator-Bioanalytical
Job Summary
Bioanalytical Study Coordinator
Labcorp is seeking a Bioanalytical Study Coordinator to join our team in Shanghai China.
Job Responsibilities:
- Independently drafts protocols; sample analysis outlines (SAOs) amendments and study schedules with some oversight using proposal outline or client-supplied information.
- Reviews study compliance against protocol SOP and regulatory agency guidelines.
- Communicates and interacts with study team other departments and clients as applicable.
- Assists in the development and maintenance of standard report/table formats as needed.
- Plans prioritizes and manages own workload and multiple responsibilities.
- Independently use project tracking systems as appropriate.
- Learns to improve processes to increase the efficiency of daily/routine procedures and reporting methods.
- Participates in and assists Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
- Responsible for report preparation including table and figure preparation. Compiles analytical information from laboratory groups.
- Ability to manage increasingly complex projects and study designs and/or increased study load.
- Assists in interpreting and evaluating data for reports.
- Maintains well documented organized and up-to-date study files including study schedule protocol and correspondence as applicable.
- Reviews QAU report audits. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
- Reviews client comments and makes decisions including appropriate study personnel as necessary to ensure that all necessary report/raw data clarifications are completed.
- Responsible for report production processes through finalization including archival of data as appropriate.
- Assists SD/PI in monitoring study progress.
- Schedules study phases in coordination with SD/PI and lab operations.
- Maintains an awareness of the financial status of ongoing studies including work scope changes.
- Performs other related duties as assigned.
Minimum Required:
- Bachelor Degree in pharmacy pharmaceutical analysis or chemistry.
- 3 months or more experience using computer and office software applications (e.g. Microsoft Word Excel MS-Access and Outlook).
Preferred Qualifications:
- Two years of study coordinator for small molecule.
- Experience on a variety of studies performed in the department and exposure to a diverse client base.
- Knowledge of regulatory agency guidelines.
- Efficient use of word processing software database spreadsheet and specialized software.
- Proficient in concise writing. Writing should require little or no external review or edit.
- Adherence to grammar punctuation composition and spelling according to company standard conventions.
Additional Job Standards:
- Excellent communication presentation and interpersonal skills.
- Excellent attention to detail.
- Efficient in prioritizing and managing time.
At Labcorp we have a passion for helping people live happy and healthy lives. Every day we provide vital information that helps our clients and patients understand their health. If you are passionate about helping people and have a drive for service then Labcorp could be a great next career step!
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging 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 and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) 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. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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Required Experience:
IC
Key Skills
About Company
Labcorp helps patients, providers, organizations, and biopharma companies to guide vital healthcare decisions each and every day.