Study Coordinator II BioA

We have an excellent opportunity for a Study Coordinator I on our BioAnalytical Team in Greenfield, IN.

Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.

In this role, you will be coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner. High volume of data and report delivery.

Essential Job Duties:

• Writes Study Protocols, Methods and Reports
  • With minimal support and guidance, drafts protocols, methods, amendments, and reports; utilizing sources such as Documentum, Toxicology protocols and client supplied information
  • Reviews study activities for compliance against protocol/SOW, Standard Operating Procedure (SOP), Policies, and regulatory agency guidelines.
  • With support, assists Scientist with report preparation, including table and figure preparation; compiles analytical information from operations teams.
  • Under direction of Scientist, supports with Quality Assurance Unit (QAU) audits of study documents, drafts responses as applicable, and follows up with appropriate personnel to ensure that all responses and/or necessary document/raw data clarifications are completed within specified timelines.
  • Reviews client comments in protocol, method drafts and reports with Scientist, works with them to determine appropriate responses; addresses comments under guidance of Scientist to ensure all necessary document/data clarifications are completed in a timely manner.
  • Supports report production processes through finalization
  • Assists with archiving of study related materials
• Drives/Maintains Study and Client Communications

• Efficiently communicate and serve as a secondary to support the Scientist with client contact on assigned studies.
• Proactively communicates and interacts with study team, other departments, and clients as applicable.
• Attends and engages in pre-initiation and other internal study-related meetings, and attends conference calls; takes and distributes meeting minutes / action items, as appropriate.
• Support PM's and Scientists with preparing for and attends routine client visits.
• With support manages data transfer to clients as requested.

• Bachelor of Science (BS) degree in science or related field preferred; experience may be substituted for education
• Ability to learn/utilize word processing software, database, spreadsheet, and specialized software
• Excellent communication and interpersonal skills
• Excellent attention to detail
• Ability to prioritize, organize, and manage time