Clinical Research Associate Jobs
By AVITA Medical At Ohio, United States
Manages progress by tracking regulatory submissions, recruitment, case report forms (CRF) completion, and data query resolution
Assist sites with the IRB submission and renewal process and tracks continuing IRB renewals. Ensure site compliance with IRB requirements
3 – 5 years clinical research experience in medical device, pharmaceutical industry or CRO as a CRA
Strong working knowledge, understanding and ability to apply FDA regulations and ICH/GCP guidelines governing clinical trials
Excellent organizational skills along with strong attention to detail and the ability to keep detailed, accurate records
Strong verbal and written communication, superior organizational and interpersonal skills
Biostatistician - Epidemiology/Clinical Research - Remote
By WESTAT At , Rockville, 20850, Md $90,000 - $105,000 a year
Participate in all phases of analytical programming, data management, macros, quality control and reporting of research data.
Expert ability to identify and resolve analytic issues using knowledge, background, problem solving and troubleshooting skills.
The anticipated pay for this role is $90-105k and will be commensurate with experience.
Collaborate with external investigators in developing study aims and research hypotheses.
Provide study design advice to investigators including assessment of appropriateness and feasibility.
Develop statistical considerations and analysis methods for study protocols.
Research Associate - Project Management - Remote
By WESTAT At , Rockville, 20850, Md $74,900 - $88,500 a year
Assist with project management activities, including monitoring the work of vendors and subcontractors.
Prepare proposal budgets and draft some technical sections of proposals such as past experience and staffing.
Demonstrated intermediate MS Excel skills such as pivot tables.
The anticipated salary range for this role is $74,900- $88,500 and will be commensurate with experience.
Provide budget and technical support to Project Directors.
Track awards status on tasks under the FDA BPA.
Research Associate - Epidemiologist - Remote
By WESTAT At , Rockville, 20850, Md $63,100 - $74,800 a year
Experience with multi-site clinical epidemiologic studies and data management preferred.
Strong communication skills, administrative abilities, and the capability to handle multiple tasks while working in a team setting are essential.
A master's degree in public health with a concentration in epidemiology and a minimum of 2 years of experience is required.
Experience with R and/or SAS.
The anticipated salary range for this role is $63.1k - $74.8k and is commensurate with experience.
Identifying and evaluating clinical study sites and research collaborators and receiving and analyzing associated health data.
Clinical Research Monitoring (Remote, Midwest/Northeast) Tmtt
By Edwards Lifesciences At Greater Madison Area, United States
3 years of previous clinical research field monitoring experience OR, quality assurance/control and regulatory compliance experience, required
Experience working in a medical device or regulated industry, preferred
Experience with electronic data capture, preferred
Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
Demonstrated problem-solving and critical thinking skills
Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
Research Analyst -Remote Jobs
By WESTAT At , Rockville, 20850, Md
Organization skills, including time management ability
Perform data management and manipulation using MS Excel spreadsheets.
Ability to manage multiple responsibilities across projects
A Bachelor’s degree in a social science discipline, with a minimum of 2 years’ of previous research experience.
Qualitative, mixed methods research experience
Experience conducting qualitative interviews (cognitive, in-depth, focus groups, usability)

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