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Clinical Research Specialist II
2 months ago
The Clinical Research Specialist II collaborates closely with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to facilitate and/or execute clinical studies, serving as a key liaison for external sponsors.
Key Responsibilities:- Evaluates and abstracts clinical research data while ensuring adherence to study protocols and objectives.
- Completes Case Report Forms (CRFs) and enters clinical research data into Electronic Data Capture (EDC) systems provided by sponsors.
- Provides limited patient interaction with research participants as necessary for the study.
- Assists with regulatory submissions to the Institutional Review Board (IRB) and collaborates with supervising research staff to report Adverse Events and Safety Letters in compliance with local and federal regulations.
- Contributes to the management of clinical trial budgets and schedules research participants for visits and procedures.
- Responsible for sample preparation, shipping, and maintaining study supplies and kits.
- Ensures compliance with all relevant federal and local regulations, including those from the Food and Drug Administration (FDA) and local IRB.
- Maintains research practices in accordance with Good Clinical Practice (GCP) guidelines and upholds strict patient confidentiality in line with HIPAA regulations.
- Participates in ongoing training and educational programs, and may assist in the training of other Clinical Research Associates.
- Acts as the primary contact for external sponsors for designated trials.
- Coordinates the activities of other associates to ensure adherence to study protocols and overall clinical research goals.
- Engages in centralized activities such as auditing and the development of Standard Operating Procedures.
- May be involved in the creation of Investigator Initiated trials for Investigational New Drug applications and/or Device applications.
Educational Background:
High School Diploma/GED required; Bachelor's Degree in Science, Sociology, or a related field preferred.
Experience:
Minimum of one (1) year of clinical research experience required.
Licensure & Certification:
Certification in Clinical Research (SOCRA or ACRP) is preferred.
Cedars-Sinai is recognized as a leader in delivering high-quality healthcare, encompassing primary care, specialized medicine, and research. Since its inception in 1902, Cedars-Sinai has adapted to meet the diverse needs of the community, setting benchmarks in quality patient care, research, education, and community service.
Today, Cedars-Sinai is renowned for its national leadership in transforming healthcare for the benefit of patients, influencing the future of healthcare through innovative treatment approaches and the education of future health professionals.
About the TeamCedars-Sinai stands as one of the largest nonprofit academic medical centers in the U.S., with a workforce that includes 886 licensed beds, 2,100 physicians, 2,800 nurses, and thousands of other healthcare professionals and staff.
This role is ideal for those seeking to thrive in a dynamic environment that provides the highest level of care to individuals in need.
