Study Coordinator - LCMS BioAnalytical

Labcorp; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A global clinical laboratory in Singapore is seeking a qualified professional to manage protocol drafting and projects. The ideal candidate will have a Bachelor’s degree and 2-4 years of experience, with strong attention to detail and excellent communication skills. Key responsibilities include reviewing compliance and managing studies effectively.

Qualifications

• Minimum 2-4 years working experience in relevant field.
• Proficient in writing with adherence to grammar and conventions.
• Knowledge of regulatory agency guidelines.

Responsibilities

• Drafts protocols, amendments, and schedules independently.
• Reviews compliance against protocols and guidelines.
• Manages workload and prioritizes responsibilities.

Skills

Concise writing

Attention to detail

Project management

Excellent communication skills

Education

Bachelor of Science/Arts (BS/BA)

Tools

Word processing software

Database software

Spreadsheet software

Job description

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 uses 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, organised 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 and 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 assigning appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
• Responsible for report production processes through finalisation, 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 utilises 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.
• Serves 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 specialised 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.
• 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 initiatives and endeavors.
• Proven ability to plan, prioritise 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 prioritising and managing time.