Documentation Data Reviewer II

Efficiently perform and document all procedures, materials, and results in compliance with applicable regulatory standards (protocols, methods, SOPs, etc.).,Demonstrate effective communication skills through informal discussions with peers, supervisor, and team.,Accurately identify and effectively communicate any issues with data.,Effectively support administrative tasks including but not limited to, filing, ordering, distribution of documents and study-related materials as needed.,Independently compile and archive data books and departmental records.,Develop critical thinking, troubleshooting, and time management skills aligned with needs of operational area.,Review and issue data sets in adherence to established timelines.,Accurately review departmental and study specific data to ensure adherence to SOPs, methods/protocols, industry standards, and regulatory requirements as applicable in a timely manner.,Oversee and maintain responsibility for one operational area with minimal oversight.,Identify data discrepancies involving collection and analyses compared to study plan by working with appropriate personnel with oversight.,Ensure sample analysis data collected is accurate against study plans, methods/type of analysis conducted and subjects' collection time points with oversight.,Create and compile report tables with oversight.,Review methods for accuracy, consistency, and formatting with oversight.,Review and monitor study schedules to ensure timelines are met with oversight.,Ensure documents align with requirements indicated in Client Information Database (CID).,Attend study and/or department related meetings to assure understanding of assigned projects.,Attain CRL personnel and Sponsor signature/approval for study documents and distribute documents when necessary.,Assist in preparation, review and/or processing of specialty data shared with Sponsors.,Independently generate and maintain standard and complex draft study plans/protocols/amendments and reporting templates in accordance with CRL or Sponsor specific requirements within one operational area.,Review laboratory study data to provide financial information for Unit Based Invoicing.,Perform all other related duties as assigned.

Bachelor’s degree (BA/BS) or equivalent in a relevant field with no previous work experience.,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 Functions, 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.

Bachelor's Degree

Must be authorized to work in the United States without a sponsor visa, now or in the future; Ability to work extended hours including evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice; Ability to work under specific time constraints; Must be onsite 5 days a week.