Job Summary

Generate reports for preclinical and clinical studies. Coordinate larger documents with multiple contributing scientists’ reports. Ensure that reports adhere to study protocols, standard templates and styles, Sponsor templates and styles, and applicable regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  
•    Extract information from protocols and study data to generate preclinical and clinical study reports including text tables. 
•    Create data tables for report from automated data collection systems or manual data if applicable.
•    Ensure that tables are an accurate representation of data as indicated by the protocol, clinical phase plan, and amendments.
•    Review contributing scientists’ sub-reports and project scientists’ 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; assist in resolving audit findings and facilitate the responses of report issues with other departments for QA resolution.
•    Use report progress monitoring database to track scheduling of deliverables to the client.
•    Participate in study-specific pre-initiation meetings as necessary; anticipate reporting issues and suggest courses of action for data collection enhancements or protocol edits.
•    Facilitate meetings with the Study Director or project scientist as necessary for study specific reports and suggest courses of action for data collection enhancements or protocol edits.
•    Assist in the creation of MS Word report templates for the various service types.
•    QC and route study related documents through the signature process.
•    Compile study reports and documentation for shipment to Sponsor.
•    Prepare report and electronic files for submission to archives.
•    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.
•    Perform all other duties as assigned.

The pay for this position is between $33.00 and $40/hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

QUALIFICATIONS:    
•    Education:  Bachelor’s degree (B.A./B.S.) in journalism, computer science, business administration, or related discipline. 
•    Experience:  3 to 5  years related experience in scientific data presentation, writing, editing, proofreading, and publishing. Experience working in a regulated environment required. 

•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Certification/Licensure:  Advanced training in applicable software applications required.
•    Other:  Scientific and medical writing knowledge and the ability to apply judgment and discretion to extract appropriate data and evaluate how to present it. Proficient skills with spreadsheet, word processing, database, and publishing software (e.g. MS Excel®, Word®, and Adobe® Acrobat® PDF 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 and clinical study protocols/reports and FDA electronic reporting compliance. Knowledge of GLP regulations.

PHYSICAL DEMANDS:
•    Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer. 
•    Regularly provides information to and receives information from/through various technologies, media, sources and contacts.  Must be able to accurately exchange accurate information in these situations.
•    Must occasionally move about inside the office to access file cabinets, office machinery, etc. 

WORK ENVIRONMENT:
•    General office working conditions, the noise level in the work environment is usually quiet.