We have an excellent opportunity for a Study Coordinator I on our BioAnalytical Team in Indianapolis, IN.Lapcorp 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.Candidates given best consideration will have the following skills/experience:
Proficient in Microsoft Excel and Microsoft Word
Highly Organized
Works Well Independently
Ability to Multi-task Effectively and Navigate Various Systems
Schedule: Core hours are 9:00am-3:00pm with flexibility on start and end times around core hours.This position is remote based.Essential Duties:
Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules as appropriate, using proposal outline or client-supplied information.
Reviews study compliance against protocol, SOP, and regulatory agency guidelines.
Learns to serves as the primary contact in communication and interaction with other departments and clients as applicable.
Updates and maintains project tracking systems as appropriate.
Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, including scheduling and leading meetings as required.
Learns to manage increasingly complex projects and study designs and/or increased study load.
Responsible for report preparation, including table and figure preparation.
Assists in 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 and submits audit responses for approval as appropriate.
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 through finalization, including archival of data as appropriate.
Assists with routine client visits as requested. Manages data transfer to clients as requested.
Assists SD/PI in monitoring study phases.
Performs other related duties as assigned.
Pay Range: $25.00Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please click here (https://careers.labcorp.com/global/en/us-rewards-and-wellness) .Labcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.We encourage all to applyIf you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site (https://careers.labcorp.com/global/en/accessibility) or contact us at Labcorp Accessibility (Disabilityapply@LabCorp.com) .For more information about how we collect and store your personal data, please see our Privacy Statement (https://www.labcorp.com/about/web-privacy-policy) .
