Study Coordinator

1 week ago


Singapore LABCORP DEVELOPMENT (ASIA) PTE. LTD. Full time
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.

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