Clinical Research Data Specialist II - Barbara Streisand Women Heart Center

Job Description The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. Are you ready to be a part of breakthrough research? The Clinical Research Data Specialist II independently manages data for assigned research studies, demonstrating a high level of expertise and autonomy. This will include, designing forms for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies. The Specialist also trains clinical research staff, perform basic statistical analysis, and collaborates with bioinformatics to develop and maintain trial management systems. Ensures compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Board. Primary Duties and Responsibilities : Collaborates with bioinformatics in the development and maintenance of clinical trials management systems including validation of systems. Prepares project reports and performs basic statistical analysis in conjunction with a biostatistician, interpreting and presenting findings to support study objectives and data quality initiatives. Identifies and resolves operational / data problems, recommending and implementing process improvement with minimal supervision Trains clinical research staff on data collection standards, protocol requirements, and data entry systems to promote accuracy and consistency in research data. Independently manages data for research studies, including processing clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data. Performs clinical data collection, abstraction, targeted data searches to support accurate and timely data availability for study objectives. Maintains the integrity, security, and confidentiality of large, computerized records systems in compliance with HIPAA and applicable regulations. Understands regulations, policies, protocols and procedures to control and maintain accurate records. Ensures all data practices comply with federal / local regulations, including FDA, IRB, and Good Clinical Practice (GCP) guidelines. Qualifications Education : Bachelor's degree in Science or Bachelor of Arts degree required. License / Certification Requirements : Certification in Clinical Research, ACRP / SoCRA (or equivalent) is preferred. Experience : Two (2) years minimum experience in related field, or equivalent combination of education and experience. Req ID : 10946 Working Title : Clinical Research Data Specialist II - Barbara Streisand Women Heart Center Department : Heart Institute Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies / Clin Trial Overtime Status : EXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $71,219 - $121,076