Clinical Research Associate II - Melmed Lab - IBD Clinical Research

Cedars-Sinai•Los Angeles, CA

About The Position

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.

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.