Data Coordinator

Data Coordinator (Remote) Southern Research + You Discover a career where your work truly matters. Southern Research has been translating science into real-world solutions since 1941. Join our innovative team and enjoy benefits like medical, dental, vision, 401(k) match, life insurance, PTO, an employee assistance program, and more. General Summary This position is responsible for performing diverse duties to support both government and commercial studies within the organization. This position is responsible for providing study support by ensuring the integrity, quality, and regulatory compliance of data and reporting generated during preclinical and clinical studies. The Data Coordinator will work closely with the Principal Investigator, Study Director/Scientist, Project Managers, Study Coordinators, Quality Control, and Sample Management to oversee preclinical and clinical data and reports generated through the lifecycle of sample. Data Coordinators are expected to share knowledge gained through experience with their internal colleagues and uphold client satisfaction. Essential Duties & Responsibilities • Coordinate and manage the documentation, data, and reports generated from through the sample life cycle within preclinical and clinical contracts. • Works with Study Director/Responsible Scientist in preparation and review of data; ensures quality control is performed and corrections made prior to submission to report writing team. • Prepare, review, and execute Data Transfer Agreements (DTA) in collaboration with client, SMO (site management organizations), clinical sites and internal teams. • Reviews shipping manifests, prepares for sample receipt, outline internal inventories, and reconciles sample/data discrepancies against analyzed data sets. • Ensure all data are complete, accurate, and timely entry into databases or electronic systems (e.g., LIMS) and able to upload DTA/data sets to secure file sharing platforms. • Develops and implements study documentation procedures according to Good Laboratory Practice (GLP) and regulatory standards. • Support generation of regulatory documents such as study reports, protocol amendments, and QA audit trails. • Prepares data summaries and assist with compiling information for FDA submissions (IND, NDA, etc.). • Set up study-specific databases and ensure proper configuration aligned with protocol requirements. • Manage data imports/exports, backups, and archival procedures. • Track study milestones and data deliverables in collaboration with project managers and clients. • Support audits and inspections by preparing required data sets and reports. • Serves as an advanced Provantis user, support internal reviews, and act as a peer reviewer for Study Coordination. Able to complete Provantis study setups, distributing to appropriate teams following Study Director/Responsible Scientist review and approval. • Available for critical study phases to address any Provantis issues in real time. • Tracks progress of studies to ensure timely execution of activities and communicates any changes to study timelines to internal and external teams. • Assures adherence to study schedules by interacting effectively with and providing information to various staff and client groups; prompts individuals and groups of needed results and approaching deadlines; and coordinates needs of one group or person with those of another group or person. • Demonstrates strong organization and communication skills while assisting with multiple projects in various stages of completion. • Works with the Study Director/Responsible Scientist to compile, summarize, maintain, report, and archive study data, including review of study data for missing, inaccurate, or improbable results. • Assists with communicating schedule and procurement requests. • Maintains study records and archive study data and reports upon study conclusion. • Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), applicable regulatory requirements, and study protocols. • Performs other coordination duties as required by study or as backup to the Study Coordination team as needed. Requirements/Minimum Qualifications • Education & Experience • Bachelor of Science (BS) with at least 2 years of data/program/study coordination experience. • Ability to learn and utilize specialty software applications (e.g., laboratory information management systems, Provantis, MS Project). • Good grasp of the fundamental concepts, practices, and procedures of microbiology/ virology/ immunology/ biology. • Effective verbal and written communication skills including correct grammar, spelling, and punctuation. • Detail oriented; possess good planning and organizational skills; inquisitive; takes direction well. • Proficiency with Microsoft Office applications (Windows, Word, Excel, Access, etc.). • Strong organization skills and capable of multi-tasking. • Ability to read, understand, retain, and apply knowledge of Good Laboratory Practices (GLP) and other study requirements. Core Values Cultivating human connection – putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world’s most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust. Operating with precise execution – measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing. Harnessing relentless curiosity – our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results. Stewarding a healthy community – implementing sustainable operations for a safe, engaging environment. We don’t compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked. Job Specific Behaviors Relationship Orientation – Develops positive relationships by making others feel their concerns and contributions are important. Continuous Learning – Proactively seeks performance feedback and identifies approaches to improve personal and others performance and learning. Tolerance for Stress, Ambiguity & Change – Demonstrates flexibility in applying different approaches to changing work demands. Effective Communication – Creates a team environment in which information flows freely and decision making is based on a win-win philosophy Compliance – Applies an understanding of key legal precedents, policies and practices to protect the interests of the organization. Cross-team Collaboration – Ensures integration and cooperation across organizational boundaries Attention to detail – Utilizes established monitoring system, records data accurately and in a timely manner, and ensures accuracy of data. Planning and Organization – Systematically identifies issues to be addressed and helps plan a course of action for self and others to ensure the accomplishment of specific objectives Operational / Technical Excellence – Ensures that work product (whether service or process) enables the organization to deliver on customer’s expectations. Physical Demands • Ability to perform work utilizing a computer for extended periods of time. • Ability to sit for extended periods of time without being able to leave the work area. • Ability to stand for extended periods of time without being able to leave the work area. Work Authorization Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.