Study Coordinator II BioA

Labcorp • Greenfield, IN

1d • $24 - $25

About The Position

Study Coordinator II -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.

Requirements

• 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

Responsibilities

• Writes Study Protocols, Methods and Reports
• Reviews study activities for compliance against protocol/SOW, Standard Operating Procedure (SOP), Policies, and regulatory agency guidelines.
• 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
• 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.
• Drives/Contributes to Process Improvement/Adherence
• Participates in the development and maintenance of standard report/table formats as needed.
• Participates in the development and maintenance of standard protocol, method and Sample Analysis Plan (SAP) formats as needed.
• Identifies opportunities to increase the efficiency of daily/routine procedures and reporting methods; provides input on and assists with implementation of new technologies, system changes, and enhancements.
• Study/Timeline Management
• With support plans, prioritizes, and manages own workload and multiple responsibilities.
• With support uses project tracking systems, as appropriate.
• Manages standard projects and study designs, and drives to increase study load over time.
• Maintains well-documented, organized, and up-to-date study files, including real-time study schedule updates, as applicable.
• Demonstrates active engagement with study progress/timelines.
• Actively promotes a team environment; identifies and escalates any activities that do not promote a team environment.
• Other related duties as assigned

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level