What are the responsibilities and job description for the Report Coordinator position at Charles River?
We are seeking an experienced Report Coordinator for our Reporting and Technical Support Services team. A Report Coordinator is responsible for coordinating the reposting processes to produce quality on-time reports; providing support for assigned Study Director(s); and independently prioritizing his/her workload. The individual in this role serves as a mentor for new employees and contributes expertise to process improvement initiatives.
Essential Duties and Responsibilities
- Generate and perform review of reports and report components for studies according to the data, protocol, format, and compliance requirements.
- Review and evaluate laboratory data for adherence to protocols and regulatory requirements; request corrections if discrepancies are detected.
- Respond to, clarify, and evaluate Quality Assurance Observations with the Quality Assurance staff; review and complete Corrective Action Preventative Action events; and address compliance issues.
- Mail reports to the Sponsor in accordance with established timelines.
- Independently evaluate and prioritize study work (scheduled and unscheduled) to determine which reporting functions to complete and communicate prioritized schedules to the Study Director and reporting team.
- Handle special customer requests, such as expedited timelines, preliminary tables, and custom formats.
- Anticipate potential study issues and proactively work toward resolutions; communicate changes in study status and reporting plan to the Study Director and study team.
- Provide customer service and consulting on report writing processes, standards, and procedural/study-related issues to Study Directors, team members, internal customers, and Sponsors.
- Serve as a subject-matter-expert within a product line and serve as a mentor for new employees.
- Contribute expertise to focus/process improvement groups within Report Services.
- Perform other related duties, as assigned.
Job Qualifications
- Education and Experience: HS/GED with 6 or more years of experience or a bachelor's/master's degree with 2 or more years of relevant experience; contract research organization experience preferred.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None
- Demonstrated ability to prioritize daily tasks and use critical thinking to anticipate and resolve study-related issues.
- Demonstrated knowledge of the reporting process.
- Ability to communicate verbally and in writing at all levels inside and outside the organization.
- Basic familiarity with Microsoft Office Suite.
- Computer skills, commensurate with Essential Duties and Responsibilities, including the ability to learn a validated system.
- Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice.
- Ability to work under specific time constraints.
Competencies
Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.
Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment OpportunityCharles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit