CLINICAL DATA SPECIALIST
Duties: The primary responsibility of the Clinical Data Specialist position is to independently implement data management-related research efforts including monitoring of Phase I-IV multi-site clinical trials, pragmatic, observational, and pharmacoepidemiologic studies, and claims and EMR database studies. Responsibilities will include management and monitoring of data collection, data quality, and dataset preparation. Data management responsibilities will also include assisting the Senior Biostatistician in developing and providing support for research databases, creating and revising CRFs, implementing data safety management plans (DSMPs), reviewing queries and reports to ensure data integrity, and communicating with study sponsors and research staff at multiple study sites for database support and discrepancy resolution. The ideal candidate for this position will be have the ability to handle a variety of clinical study related responsibilities in accordance with University of Pennsylvania, GCP, ICH, and FDA guidelines, have experience in the design of data systems for analysis of medical outcomes, and be able to understand the needs of complex clinical research protocols.
The duties of the Clinical Data Specialist include but are not limited to
* Electronic Data Capture Systems Development: Serve as lead liaison with external technology vendors and test new system solutions and interfaces for data collection and management; integrate vendor application platforms with UPenn study data capture systems and electronic medical records; guide development of CRFs, both application-based (for iOS and Android) and web-based, to collect information required for primary and secondary endpoints; train research staff on CRFs and data capture systems at all study sites (40-50 sites)
* Database Management: Query databases for data accuracy and coordinate with research staff to address discrepancies and maintain data integrity at 40-50 study sites; review/confirm resolution of data discrepancies in all EDCs; compile and submit to investigators, stakeholder committees, and study sponsors monthly data discrepancy and adverse event reports; ensure security of databases; prepare and submit quarterly and annual data safety reports and programmatic evaluations to study sponsors
* Data Monitoring Responsibilities: Develops and oversees the implementation of onsite and remote data safety monitoring plans (DSMPs) to ensure study participant safety and document data quality; continually evaluate EDCs and CRFs for required modification due to dynamic nature of research studies; coordinate and provide guidance to junior CRCs for initiation, interim, and closeout visits with external study sites.
* Data Analyses: Create data sets from internal and external data sources, perform statistical programming and analyses under the guidance of the senior biostatistician; learning new statistical techniques, support writing of manuscripts for peer reviewed journals
* Study Enrollment Tracking Responsibilities: Develop and implement recruitment tracking methods for 40-50 study sites. Monitoring enrollment milestones and create and present reports to research team, lead investigators, and study sponsors.
* Support and communicate with principal investigators, co-investigators, project manager, and other coordinators as needed for the successful execution of the clinical trials.
* Operations Oversight Responsibilities: Develop plans and systems to oversee dosing protocol compliance, adverse event reporting, and data collection at 40-50 study sites. Direct and oversee the efforts of junior CRCs on the drafting and maintenance of study guidance documentation (e.g. MOPs, lab manual, data management plans, data system SOPs, etc.).
* Performing additional duties as assigned
* Adhering to all University of Pennsylvania, GCP, ICH, and FDA guideline
Qualifications: The qualifications required for the Clinical Data Specialist position include:
* The minimum of a BS/BA with concentrations/majors/minors preferably in health, science, clinical data management, applied mathematics, statistics, informatics, or computer science and 3-5 years of experience in clinical research and database management, or an equivalent combination of education and experience required, Master's degree preferred.
* Knowledge of IRB and Human Research Protection Regulations
* Working knowledge of electronic data capture systems, database design, and data management required. Preference given to candidates with demonstrated knowledge and programming experience in UNIX, R, SQL, and PYTHON.
* Ability to follow detailed clinical research protocols
* Excellent organization skills and demonstrated attention-to-detail
Reference Number: 40-27587
Salary Grade: 027
Employment Type: Exempt
Job Family: I-Technical/Professional Research