The Urology Clinical Research Associate I supports clinical studies by coordinating with research staff, ensuring protocol compliance, and managing data collection and reporting. Responsibilities include case report form completion, regulatory submissions, patient scheduling, and maintaining study supplies under Good Clinical Practice guidelines. This role requires attention to detail, adherence to federal regulations, and collaboration within a medical research team focused on advancing urology therapies.
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. With a team focused on effective pain management and quick recovery, Cedars-Sinai has been ranked as the No. 1 hospital in Southern California for Orthopaedics by U.S. News & World Report. Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
The Clinical Research Associate I (CRAI) will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for study and assists with study/long term follow-up research participants only.
Primary Duties & Responsibilities:
• Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
• Evaluates and abstracts clinical research data from source documents.
• Ensures compliance with protocol and overall clinical research objectives.
• Completes Case Report Forms (CRFs).
• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Provides supervised patient contact or patient contact for long term follow-up patients only.
• Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Assists with clinical trial budgets.
• Assists with patient research billing.
• Schedules patients for research visits and research procedures.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• 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.
• Participates in required training and education programs
Educational Requirements:
High School Diploma/GED
Bachelors degree in science or related degree preferred
Experience:
1-year clinical research related experience preferred
Physical Demands:
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Understanding of general clinical research objectives. Clinical research experience, preferred
Req ID : 7502clinical research, data management, protocol compliance, case report forms, regulatory submissions, patient scheduling, Good Clinical Practice, clinical trials, urology research, FDA compliance
...have: experience in deploying an asset management solution Overall IT generalist Security minded / focused Nice to have: IAM (Okta) experience Company Description Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client...
...Netflix is one of the world's leading entertainment services, with 283 million paid memberships in over 190 countries enjoying TV series, films and games across a wide variety of genres and languages. Members can play, pause and resume watching as much as they want, anytime...
...ManTech seeks a motivated, career and customer-oriented Program Security Officer 3 (PSO 3) to join our team in Chantilly, VA. Responsibilities include but not limited to: Provide advice and assistance regarding a range of security issues and concerns to government...
...leave of up to 6 weeks for eligible employees*~ Free regional bus pass *Click HERE for more information on our employee benefits... ...taking part in creating amazing guest experiences through providing clean and sanitary facilities and if you have professional cleaning...
...make the world a better place. What you'll do in this role: Assist with the development of important daily living skills and life... ...Desire to make a positive difference in people's lives. No experience needed. We provide thorough training. Must be 18 years of age...