Cedars-Sinai · 1 day ago
Clinical Research Associate II - Melmed Lab - IBD Clinical Research
Cedars-Sinai is a leader in providing high-quality healthcare and is seeking a highly motivated Clinical Research Associate II to join Dr. Gil Melmed's dynamic team in the Melmed Lab. The role involves coordinating and implementing complex research studies, supporting research objectives, and maintaining compliance with guidelines while working closely with various research staff.
CommunitiesHealth CareMedicalNon Profit
Responsibilities
Collects, evaluates and/or abstracts clinical research data
May assist in designing forms for data collection/abstraction
Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors
Completes Case Report Forms (CRFs)
Independently prescreens potential research participants for various clinical trials
May provide increasingly independent contact with research participants and/or conduct research participant visits independently
Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB)
Assists with clinical trial budgets and patient billing
Responsible for sample preparation and shipping and maintenance of study supplies and kits
Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law
May serve as the primary point of contact for external sponsors for select trials. Responds to sponsor inquiries and attends meetings regarding study activities
Participates in and provides training and education to other Clinical Research Associates
May assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc
May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
May provide coverage for study coordination activities of supervising staff when needed to ensure minimal disruption to study objectives
Independently supports screening and prescreening of research participants for protocol eligibility; assists with scheduling research visits and procedures; presents non-medical trial information and participates in the informed consent process in collaboration with the study team and in accordance with IRB-approved procedures
Coordinates and manages program-related teleconferences, meeting logistics, and travel arrangements; maintains investigator calendars related to research activities and study commitments
In collaboration with the study team, participates in planning and coordinating strategies to enhance participant enrollment, improve study efficiency, and support ongoing study operations, including participation in team meetings or huddles
Prepares and maintains data summaries, tracking logs, and spreadsheets to support investigators, sponsors, and departmental reporting needs
Assists with preparation of grant proposals, manuscripts, abstracts, and presentations related to research activities, as appropriate
May travel independently to attend investigator meetings, sponsor meetings, or learning sessions related to assigned studies or projects
Participates in required training, education, and professional development activities to maintain regulatory knowledge and support continued growth in clinical research responsibilities
Performs other related duties and responsibilities as assigned to support research objectives and departmental needs
Qualification
Required
High School Diploma/GED is required
1 year of clinical research related experience is required
Company
Cedars-Sinai
Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service.
H1B Sponsorship
Cedars-Sinai has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (91)
2023 (81)
2022 (92)
2021 (92)
2020 (65)
Funding
Current Stage
Late StageTotal Funding
$63.31MKey Investors
American Academy of Orthopaedic SurgeonsCalifornia HealthCare FoundationNational Heart, Lung and Blood Institute
2023-12-01Grant· $0.01M
2023-05-25Grant· $28M
2022-06-16Grant· $7M
Leadership Team
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