Study Coordinator - LCMS Bioanalytical

Posted 3 Days Ago
Be an Early Applicant
Singapore
In-Office
Junior
Healthtech • Biotech
The Role
The Study Coordinator will draft protocols, manage study compliance, communicate with teams, prepare reports, and assist in project management tasks, ensuring adherence to regulatory guidelines.
Summary Generated by Built In

Job Level & compensation offered may vary depending on candidates’ experiences and competencies.

Responsibilities / Duties

  • 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. 

  • 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.

  • Performs quality control review of data.

  • With supervisory assistance, assures technical staff compliance to SOPs and other regulatory agency guidelines.

  • Provides input and participates in project meetings, plans, monitors and guides project work.

  • Trains, mentors, and assists less experienced staff.

  • Participates in client visits as needed, assists in communicating technical information.

  • Participates in process improvement initiatives.

  • Effectively plans and utilizes personnel and resources for timely completion of assigned projects.

  • Assists in writing reports and protocols.

  • Writes SOPs and methods.

  • Maintains an awareness of the financial status of ongoing studies

  • Serve as the primary contact in communication and interaction with other departments and clients as applicable.                                                                                                     

  • Serves as a backup PI/SD on project management tasks.

  • Performs other related duties as assigned.     

Requirements :

  • Minimum Bachelor of Science/Arts (BS/BA) degree with 2-4 years working experience

  • At least two years related or relevant experience.

  • Experience may be substituted for education.

  • 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 accordingly to company standard conventions.

  • Experience on a variety of studies performed in the department and exposure to a diverse client base.

  • Knowledge of regulatory agency guidance.

  • Proven ability to participate in and assist Study Director/Principal Investigators with pre-initiation and other study related meetings as required.                                                         

  • Proven ability to manage increasingly complex projects and study designs and/or increased study load.                                                                              

  • Demonstrated capability to manage work for key clients.                                                 

  • Demonstrated ability to support and be involved in process improvement initiates and endeavors          

  • Proven ability to plan, prioritize and manage workload and multiple responsibilities.      

  • Demonstrated ability to independently use project tracking systems as appropriate.

  • Excellent communication, presentation and interpersonal skill.

  • Excellent attention to detail

  • Efficient in prioritizing and managing time.

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

If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

Top Skills

Database
Specialized Software
Spreadsheet
Word Processing Software
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The Company
HQ: Burlington, NC
19,796 Employees
Year Founded: 1978

What We Do

We believe in harnessing science for human good. And so we work day and night, around the world, to deliver answers for all your health questions—whether you’re a provider, drug developer, hospital, medical researcher or patient. That means everything from advancing diagnostic testing to helping launch new drugs, to offering new perspectives through data - all drawing from a deep well of scientific expertise. So when you need trusted information to make clear, confident health decisions, consider us your source.

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