Clinical Research Associate Jobs
By Balt USA At , Irvine
Experience in clinical study management required.
Manages Trial Management Filing (TMF) system, including document inspection, filing, and auditing.
Serves as key facilitator and liaison for shipping, receiving, and management of study devices.
Ability to constructively interact directly with senior management teams.
Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
Manages study and site materials, including, but not limited to study binders, study trackers, training documentation.
Clinical Research Project Coordinator - 100% Remote
By Celerion At , Lincoln, 68502, Ne
Conference room booking, lunch orders, visitor management
Monitor and maintain tracking tools, clinical systems and shared document repositories utilized for project management
Post high school education in life sciences or medical training preferred
Experience in clinical research, specifically early phase studies, preferred
Document creation / editing / QC
Create and enter data/information into SharePoint, Word, Excel, etc.

Are you looking for a unique opportunity to make a difference in the healthcare industry? We are seeking a Remote Clinical Research Associate to join our team and help us develop innovative treatments for patients. You will be responsible for monitoring clinical trials, ensuring compliance with protocols, and providing support to investigators and sponsors. If you have a passion for clinical research and want to make a real impact, this is the job for you!

Overview A Remote Clinical Research Associate (CRA) is a professional who is responsible for the management and coordination of clinical trials. The CRA is responsible for ensuring that the clinical trial is conducted in accordance with the protocol, applicable regulations, and Good Clinical Practices (GCP). The CRA is also responsible for monitoring the progress of the clinical trial, ensuring that the data collected is accurate and complete, and reporting any adverse events or other issues to the sponsor. Detailed Job Description

The Remote Clinical Research Associate is responsible for the management and coordination of clinical trials. This includes:

• Developing and maintaining relationships with clinical sites and investigators
• Ensuring that the clinical trial is conducted in accordance with the protocol, applicable regulations, and Good Clinical Practices (GCP)
• Monitoring the progress of the clinical trial
• Ensuring that the data collected is accurate and complete
• Reporting any adverse events or other issues to the sponsor
• Assisting in the preparation of regulatory documents
• Assisting in the preparation of clinical study reports
• Assisting in the preparation of data for submission to regulatory authorities
• Assisting in the preparation of presentations for investigators and other stakeholders
• Assisting in the preparation of training materials for investigators and other stakeholders
• Assisting in the preparation of budgets and contracts
• Assisting in the preparation of study materials
• Assisting in the preparation of study protocols
• Assisting in the preparation of informed consent forms
• Assisting in the preparation of study reports
• Assisting in the preparation of study databases
• Assisting in the preparation of study manuals
• Assisting in the preparation of study monitoring plans
• Assisting in the preparation of study closure documents
Job Skills Required
• Excellent communication skills
• Strong organizational skills
• Ability to work independently and as part of a team
• Ability to manage multiple tasks and prioritize workload
• Knowledge of clinical trial regulations and Good Clinical Practices (GCP)
• Knowledge of clinical trial processes and procedures
• Knowledge of clinical trial data management
• Knowledge of clinical trial software
• Knowledge of medical terminology
• Knowledge of medical devices
• Knowledge of clinical research terminology
Job Qualifications
• Bachelor’s degree in a related field
• At least two years of experience in clinical research
• Certification as a Clinical Research Associate (CRA)
Job Knowledge
• Knowledge of clinical trial regulations and