Report Coordinator Specialist - Integris BioServices, LLC dba KCAS Bioanalytical and Biomarker Services
Olathe, KS 66051
About the Job
When you work as the Report Coordinator Specialist at KCAS Bio, you are an essential part of a technical writing team and assist in accurately reporting pre-clinical and clinical bioanalytical data and become part of implementing or developing new processes that helps reduce the data to report timelines.
Our Pharma Discovery lab team uses their expertise to perform fast turnaround on client ideas at the earliest stages of the research process, including testing new drug molecular structures or delivery mechanisms.
Learn more about our work in Pharma Discovery here: Discovery & Early Development Services - KCAS Bio
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In this role, we will rely on you to:
- Extract information from protocol and study data to generate the materials and methods sections of study reports
- Create data tables for reports from automated data collection systems or manual data if applicable
- Ensure that tables are an accurate representation of data as indicated by the protocol and amendments
- Review contributing scientists' sub-reports for completeness and adherence to regulatory compliance requirements
- Import data tables and contributing scientists' sub-reports using appropriate technical tools
- Create and update electronic report files to maintain document control
- Create file-searchable PDF version of the report deliverable and incorporate scientific sub-reports in accordance with FDA guidelines
- Prepare documents for submission to the Quality Assurance Unit; resolve audit findings and facilitate the responses of report issues with other departments for QA resolution
- Participate in study-specific pre-initiation meetings; anticipate reporting issues and suggest courses of action for data collection enhancements or protocol edits
- Facilitate meetings with the Study Director as necessary for study specific reports and suggest courses of action for data collection enhancements or protocol edits
- Proofread study protocols prior to submission for the study director's signature
- Compile study reports and documents and communicate to sponsors
- Prepare report and electronic files for archiving if needed
- Under the direction of the Supervisor, work on process improvement projects to enhance department efficiency, data collection, or data presentation specifically related to the implementation, training and utilization of new systems and software related to reporting
- Work with technical staff for predetermining data reporting issues directly impacted by data collection
To qualify specifically for this role, you will have:
- Bachelor's degree (B.A./B.S.) in journalism, computer science, physical sciences, business administration, or relateddisciplines
- Scientific and medical writing knowledge and the ability to apply judgment and discretion to extract appropriate data and evaluate how to present it
- Proficiency with spreadsheets, word processing, databases, and publishing software (e.g., MS Excel, Word, and AdobeAcrobatPDF software)
- Ability to perform file conversion and compilation
- Strong written, verbal, and analytical skills
- Excellent organizational and communication skills. Ability to work with all levels of staff.
- Ability to adjust priorities to adhere to stringent deadlines
- Knowledge of medical terminology
- Familiar with preclinical study protocols/reports and FDA electronic reporting compliance
- Familiarity with Provantis system and Business Objects preferred
- Knowledge of GLP (Good Laboratory Practices) regulations
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(Please note this is a representative summary of responsibilities, not a comprehensive or exclusive list of the duties to be performed in any position. Employees must follow instructions and perform additional duties as requested.)
WHO YOU ARE
You will thrive at KCAS Bio if you enjoy a relational environment, are purpose- and values-driven, embrace constant development and supportive leadership, and enjoy being part of innovative work.
WHAT YOU'LL GET
Our benefits include, and extend beyond, the traditional package. At KCAS Bio, you will enjoy company sponsored events like food trucks, family days and spirit days. You will grow in your career with KCAS University. You will be able to connect with like-minded employees to further KCAS Bio's approach to key areas such as wellness, inclusion, and community outreach. You will engage as an owner in our stock ownership program. You will have access to the latest technology. And you will be able to invest in the community with paid time off to volunteer.
WHO WE ARE
We are a fast-growing contract research organization (CRO) headquartered in Kansas City, pioneering the latest drug development in both human and animal health fields. Demand for our expertise is growing and so is our need for great people to work in nimble, empowered teams committed to one another's growth. At KCAS Bio, we advance both great science AND great people.
KCAS Bio is proud to be an Equal Opportunity Employer. Among other things, we provide equal employment opportunities without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, sex, sexual orientation, gender identity, or any other legally protected category; we recruit qualified candidates without regard to citizenship status based on internal processes that enable us to hire the right candidates consistent with the appropriate U.S. Immigration framework; and (3) we work with and provide reasonable accommodations to individuals with disabilities and for sincerely held religious beliefs, observances, and practices. Anyone who needs reasonable accommodation may send an email to kcasrecruiting@kcasbio.com or call 913-248-3000 (for TTY assistance call 711) and ask for Human Resources.
