Clinical Data Coordinator
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Cognitive Research Corporation
US
Summary
The Clinical Data Coordinator supports the Clinical Data Manager in managing clinical data processes, including database builds, data review, and closure. They are responsible for maintaining documentation, performing quality control checks, and ensuring all activities adhere to SOPs and regulatory guidelines.
Job Description
The Clinical Data Coordinator supports the Clinical Data Manager in delivery of Data Management contracted services on assigned projects. This includes responsibility for tasks and processes associated with database build, data review and closure of the database.
Essential Duties and Responsibilities
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Reads and follows the Data Management Plan (DMP) for ongoing projects
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Assists in development of Clinical Data Management Systems including QC or testing activities required for database finalization
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Performs testing on custom reports and listings
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Assists with development of supporting Data Management documentation as required, including but not limited to: CRF Completion Guidelines, Test Subject Cases and Data Entry Guidelines
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May perform data entry and/or verification tasks as necessary for assigned projects
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Conducts Data Management tasks for data review, including production of reports, listing, or other outputs required, authoring / issuing queries, data reconciliation and query updates
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Assists the Clinical Data Manager with data review metrics and reporting
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Conducts database maintenance activities, including permissions activities, end user training, andmaintenance of training records
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Conducts all activities and files documentation in accordance with SOP requirements and TMF filing guidelines
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Performs final Quality Control check of profiled clinical data against paper CRFs for paper studies
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Perform other duties as assigned by management
Qualifications
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Bachelor’s degree in a related field of study or equivalent combination of education and work experience preferred
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2 years experience in clinical research preferred
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Medical terminology exposure preferred
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Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations
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Transferrable skills in a related industry role is an asset
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Proficiency in Microsoft Word, Excel, and Outlook
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Effective verbal and writing skills; English + local language, if relevant
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Ability to travel <10%
Cognitive Research Corporation (CRC) is a specialized contract research organization (CRO) with an exclusive focus on supporting Phase I-III central nervous system (CNS) clinical research. Founded in 2006, CRC was built from the ground up around the complexity, nuances, and demands of neuroscience research. That singular focus, twenty years of doing one thing and doing it well, is what makes CRC different and what makes our team effective.
CRC was founded with a clear purpose: to deliver a better CRO experience for CNS. More scientific depth. More consistency. A higher standard of accountability than what the industry was delivering. Twenty years later, that conviction still drives how CRC operates. Every process, every team member, and every site relationship has been purpose-built for CNS, and the grounded experience that comes from two decades of doing this work the right way shows up in every program. CRC is a team brought together by shared passion and determination, people who care deeply about transforming care for CNS disorders and who hold themselves to exactly that.
That is how CRC delivers a better CRO experience: approaching clinical research boldly, challenging the status quo, and showing up fully committed to every sponsor bold enough to take it on.
CNS breakthroughs favor the bold. Build your legacy of CNS innovation boldly with CRC.
Learn more at www.cogres.com.
Founded
2006
Company size
51-200 employees
Industry
Research Services
Org type
Privately Held
Headquarters
Saint Petersburg, Florida
Cognitive Research Corporation (CRC) is a specialized contract research organization (CRO) with an exclusive focus on supporting Phase I-III central nervous system (CNS) clinical research. Founded in 2006, CRC was built from the ground up around the complexity, nuances, and demands of neuroscience research. That singular focus, twenty years of doing one thing and doing it well, is what makes CRC different and what makes our team effective.
CRC was founded with a clear purpose: to deliver a better CRO experience for CNS. More scientific depth. More consistency. A higher standard of accountability than what the industry was delivering. Twenty years later, that conviction still drives how CRC operates. Every process, every team member, and every site relationship has been purpose-built for CNS, and the grounded experience that comes from two decades of doing this work the right way shows up in every program. CRC is a team brought together by shared passion and determination, people who care deeply about transforming care for CNS disorders and who hold themselves to exactly that.
That is how CRC delivers a better CRO experience: approaching clinical research boldly, challenging the status quo, and showing up fully committed to every sponsor bold enough to take it on.
CNS breakthroughs favor the bold. Build your legacy of CNS innovation boldly with CRC.
Learn more at www.cogres.com.
Founded
2006
Company size
51-200 employees
Industry
Research Services
Org type
Privately Held
Headquarters
Saint Petersburg, Florida