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.

We are seeking an experienced Report Coordinator for our Reporting and Technical Support Services team in Mattawan MI.

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. 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.

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.

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

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.

Charles River is an early-stage contract research…