Clinical Research Associate II/Certified Phlebotomy Technician (CPT) - Melmed Lab - IBD Clinical Research (Onsite)

Cedars-Sinai Medical Center•Los Angeles, CA

18h•Onsite

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 research of Dr. Gil Melmed focuses on clinical outcomes research in inflammatory bowel disease. Specifically, the Melmed lab is interested in improving medical and surgical outcomes, health-related quality of life, and quality of care. His research includes the role of vaccination in preventing infection, IBD disease phenotype and classification, and outcomes after surgery. Dr. Melmed oversees clinical trials of novel agents and devices for Crohn's disease and ulcerative colitis. 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. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. 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. May serve independently as study coordinator for minimal number of noncomplex research studies or projects.

Requirements

High School Diploma/GED is required.
1 year of clinical research related experience is required.
CA Phlebotomy Certification is required upon hire.

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).
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).
May work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc in accordance with local and federal guidelines.
Assists with clinical trial budgets and patient billing.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with protocol and overall clinical research objectives.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
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.
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.