Clinical Research Associate II - Melmed Lab - IBD Clinical Research at Cedars-Sinai

Los Angeles, California, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Apr, 26

Salary

0.0

Posted On

28 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Data Collection, Regulatory Submissions, Patient Confidentiality, Good Clinical Practice, Budget Management, Training, Participant Enrollment, Data Entry, Research Coordination, IRB Compliance, Sample Preparation, Communication, Team Collaboration, Problem Solving, Time Management

Industry

Hospitals and Health Care

Description

We invite you to consider this great opportunity! When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai. Dr. Gil Melmed is seeking a highly motivated Clinical Research Associate II to join a dynamic team! The Melmed Lab focuses on translational stroke, brain aging and cerebrovascular research using team science and innovation. Our goal is to identify novel therapeutics and best practices in medicine to prevent long-term disability from stroke, brain aging and cerebrovascular disease. The Clinical Research Associate II works independently but in close collaboration with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, other supervising staff to coordinate and/or implement increasingly complex research studies. The incumbent supports objectives of research studies through non-complex tasks such as data collection, prescreening and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. The CRA II member provides increasingly complex and independent support for studies by serving as the independent contact with sponsors, IRB, and research participants, providing training, education to junior level staff, and coordination of ad hoc activities related to studies. This position may serve independently as study coordinator for minimal number of noncomplex research studies or projects. Primary Job Duties and 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. Department-Specific Duties and Responsibilities: 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. Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents. Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.

Responsibilities

The Clinical Research Associate II coordinates and implements research studies, supporting objectives through tasks such as data collection and participant scheduling. They also serve as a contact for sponsors and assist with regulatory submissions and compliance.