A Scientist, Study Coordination works under minimal supervision and assists Bioanalytical Study Management Team who oversee the conduct of regulated and non-regulated studies. They assist with study management as directed by the Head of Bioanalytical Study Management, and/or Bioanalytical Study Management Team and serve as a liaison between Bioanalytical Study Management, Study Coordination, Quality Control Reviewers, Quality Assurance Auditors, and Document Coordination staff to coordinate study assignments and ensure all applicable quality control timelines are met.
What you will do
Ensure quality of deliverables including data, reports, and electronic files
Draft written procedures and templates to maintain a standardized quality output.
Assist in assigning studies, scheduling, and coordinating to maintain the flow of studies and to meet timelines.
Assist with communications with analysts and other personnel involved in conducting the studies.
Assist with cross-department communication as necessary to ensure adherence to current policies.
Assist with the review of data using scientific judgment regarding the quality and integrity of data and records associated with assigned studies.
Assist with conducting/ensuring the study is in accordance with applicable SOPs, GLPs, study plans, and protocols.
Assist in writing, preparation, and review of Sample Analysis Plans, Validation Plans, Analytical Test Methods, reports, SOPs, and protocols.
What you will bring to the role
Highly developed organizational and time management skills
Proven experience in study coordination tasks and study requirements, usually associated with three years on-the-job the experience within the study coordination role or similar internal role.
Ability to coordinate multiple studies and tasks and have the flexibility needed to adjust to changing priorities and unforeseen events.
Ability to prioritize work and define steps needed to achieve assigned study and task goals.
Your experience
Bachelor's degree, with a scientific focus, and five or more years of relevant work experience required.