Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules with some oversight, using proposal outline or client-supplied information.
Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
Responsible for data table compilation including quality review oversight and data table transfer.
Communicates and interacts with study team, other departments, and clients as applicable.
Serve as the primary contact in communication and interaction with other departments and clients as applicable.
Proven ability to plan, prioritize and manage workload and multiple responsibilities.
Demonstrated ability to independently use project tracking systems as appropriate.
Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence as applicable.
Assists SD/PI in monitoring study progress.
Serves as a backup PI/SD on project management tasks.
Schedules study phases in coordination with SD/PI and lab operations.
Proven ability to participate in and assist Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
Proven ability to manage increasingly complex projects and study designs and/or increased study load.
Demonstrated capability to manage work for key clients.
Demonstrated ability to support and be involved in process improvement initiates and endeavors.
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 completed within specified timelines.
Assists with routine client visits as requested.
Performs other related duties as assigned.
Assists in setting up and performing method development and validation of various analytes in a variety of matrices.
Performs complex analyses using unfamiliar or new methods, asking for scientific guidance as needed.
Makes suggestions for modifications in test methods or procedures.
Experience:
Minimum Required: Two years of study coordinator for large molecule or related experience.
Excellent communication, presentation, and interpersonal skills.
Excellent attention to details.
Efficient in prioritizing and managing time.
Education
Minimum Required: BS/BA degree in science plus at least 4-year experience or MS degree with 2-4-year experience.
Efficient use of word processing software, database, spreadsheet, and specialized software.
Proficient in concise writing. Writing should require little or no external review or edit.
Adherence to grammar, punctuation, composition, and spelling according to company standard conventions.
Experience on a variety of studies performed in the department and exposure to a diverse client base.
Knowledge of regulatory agency guidelines.
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. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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