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Full-time
bachelor degree
Posted 5h ago
~40 hrs/week
Responsibilities
The Study Coordinator is responsible for drafting protocols, managing study schedules, and ensuring compliance with SOPs and regulatory guidelines. They oversee report production, coordinate with laboratory groups, and serve as a primary contact for clients and other departments.
Requirements
A Bachelor's degree in Chemistry or Analytical Chemistry is required. Preferred candidates have at least 3 months of experience with regulatory agency guidance and a variety of departmental studies.
Full job description
Labcorp is a leader in diagnostics, drug development and healthcare innovation. Across every role, we harness data and AI to work smarter, move faster and create breakthrough solutions that improve health outcomes for people. With our global scale and deep expertise, you'll do meaningful work, grow your career and make a real impact. Together, we're improving health and improving lives.
Immunochemistry Study Coordinator – Bioanalytical
Work Schedule: Monday to Friday 9:00am - 6:00pm
Job Responsibilities:
Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules with some oversight, using proposal outline or client-supplied information.
Reviews study compliance against protocol, SOP and regulatory agency guidelines.
Communicates and interacts with study team, other departments and clients as applicable.
Assists in the development and maintenance of standard report/table formats as needed.
Plans, prioritizes and manages own workload and multiple responsibilities.
Independently use project tracking systems as appropriate.
Learns to improve processes to increase the efficiency of daily/routine procedures and reporting methods.
Participates in and assists Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
Assists in interpreting and 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. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
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 processes through finalization, including archival of data as appropriate.
Assists SD/PI in monitoring study progress.
Schedules study phases in coordination with SD/PI and lab operations.
Performs quality control review of data.
With supervisory assistance, assures technical staff compliance to SOPs and other regulatory agency guidelines.
Provides input and participates in project meetings, plans, monitors and guides project work.
Trains, mentors, and assists less experienced staff.
Participates in client visits as needed, assists in communicating technical information.
Participates in process improvement initiatives.
Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
Assists in writing reports and protocols.
Writes SOPs and methods.
Maintains an awareness of the financial status of ongoing studies
Serve as the primary contact in communication and interaction with other departments and clients as applicable.
Serves as a backup PI/SD on project management tasks.
Performs other related duties as assigned.
Minimum Qualifications:
Bachelor Degree of Science in Chemistry or Analytical Chemistry.
Preferred Qualifications:
3 months or more experience and knowledge of regulatory agency guidance.
3 months or more experience on a variety of studies performed in the department and exposure to a diverse client base.
Additional Job Standards:
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 accordingly to company standard conventions.
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
Proven ability to plan, prioritize and manage workload and multiple responsibilities.
Demonstrated ability to independently use project tracking systems as appropriate.
Excellent communication, presentation and interpersonal skill.
Excellent attention to detail
Efficient in prioritizing and managing time.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging 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 and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), 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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Laboratory Corporation of America Holdings is a life sciences company that is integrated in guiding patient care, providing clinical laboratory and end-to-end drug development services. The Company operates as a healthcare diagnostics company. The Company operates through two segments: LabCorp Diagnostics (LCD) and Covance Drug Development (CDD). The LCD segment is an independent clinical laboratory business, which offers menu of frequently requested and specialty testing through an integrated network of primary and specialty laboratories across the United States. The CDD segment offers drug development services, and provides a range of drug research and development (R&D) and market access services to biopharmaceutical companies and medical device companies across the world. It serves a range of customers, including managed care organizations (MCOs), biopharmaceutical companies, governmental agencies, physicians and other healthcare providers.
Offices: 358 S MAIN ST, Burlington, North Carolina 27215-5837, us
Laboratory Corporation of America Holdings is a life sciences company that is integrated in guiding patient care, providing clinical laboratory and end-to-end drug development services. The Company operates as a healthcare diagnostics company. The Company operates through two segments: LabCorp Diagnostics (LCD) and Covance Drug Development (CDD). The LCD segment is an independent clinical laboratory business, which offers menu of frequently requested and specialty testing through an integrated network of primary and specialty laboratories across the United States. The CDD segment offers drug development services, and provides a range of drug research and development (R&D) and market access services to biopharmaceutical companies and medical device companies across the world. It serves a range of customers, including managed care organizations (MCOs), biopharmaceutical companies, governmental agencies, physicians and other healthcare providers.
Offices: 358 S MAIN ST, Burlington, North Carolina 27215-5837, us