Report Coordinator

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

About the role

We are seeking an experienced Report Coordinator for our Reporting and Technical Support Services team in Mattawan, MI. The individual in this role serves as a mentor for new employees and contributes expertise to process improvement initiatives. Technical competence, good communication skills, and the ability to adhere to deadlines are necessary for success.

The pay for this position is $24/hr USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Responsibilities

• Provides administrative, logistical, and technical support for Scientific staff conducting studies or supporting functions for operations of the laboratory.
• Coordinates all laboratory support, pre-study activities, method development, method validation, study activities, data, and/or reporting activities.
• Responsible for data review for completeness, quality, or QC against the applicable protocol or procedure.
• May be responsible for drafting client correspondence, study correspondence, reporting, or direct client interaction.
• Interacts with other departments, scientific staff, and sponsors either locally or across sites.
• 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.

Requirements

• 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.
• 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.
• Must be authorized to work in the United States without a sponsor visa, now or in the future.

About the team

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 the company

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, 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.