Study Coordinator - LCMS BioAnalytical

Roles & Responsibilities

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 :

Tell employers what skills you have

Quality Control

Process Improvement

Tracking Systems

Interpreting

Protocol

Compliance

Attention to Detail

Writing

Laboratory

Audit