Clinical Research Associate Jobs
By HemoSonics, LLC At , Durham, 27703
Experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support
Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
Ability to identify customer requirements and manage expectations for clinical studies
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
Working knowledge of clinical research methods and practices for medical devices, including IDE and CE Mark studies.
Clinical Research Associate I, Dcri
By Duke University At , Durham, 27710
Review education and training experience with line manager and complete identified training needs within designated time period.
*Basic knowledge of site management and clinical monitoring for clinical research studies
Maintain job knowledge and skills through independent self-study.
OR EQUIVALENT COMBINATION OF EDUCATION AND EXPERIENCE
None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Perform assessment of site personnel and facilities for study conduct through feasibility and site telephone qualification
Sr. Clinical Research Associate Ii
By Labcorp At , Durham, 27703, Nc $120,000 - $155,000 a year
Advanced site monitoring; study site management; and registry administration skills.
Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
Thorough knowledge of monitoring procedures; Basic understanding of the drug accountability process
Good planning, organization and problem-solving abilities; Ability to work with minimal supervision
Organize and make presentations at Investigator Meetings
Participate in the development of protocols and Case Report Forms and clinical trial reports as assigned
Clinical Research Auditor I - Remote
By Be The Match At , Minneapolis, 55413, Mn
Bachelor’s degree in healthcare/science related field. However, upon evaluation, equivalent related experience and/or education may be substituted for the degree requirement.
Clinical research study processes, study design and/or protocol management.
Receives guidance and mentoring to manage complex issues.
Training and conflict resolution skills.
Manage multiple deadlines and priorities while ensuring quality and timeliness.
Work effectively and efficiently in a remote environment.
#Assistant Clinical Research Associate
By ABBVIE At , , Pr
Appropriate life-science or healthcare-related qualification or experience or equivalent work experience.
Participates in the study startup activities and site opening activities as well as study conduct and site closure tasks.
Demonstrated business ethics and integrity.
Clinical Research Associate Ii
By Penumbra, Inc. At Home, KS, United States
Participate in the monitoring functions in a clinical study including site management, qualification, initiation, routine monitoring, and final close out.*
Assist Clinical management with the development, negotiation, and execution of the site contract, budget, and payment plan.*
Provide mentoring to junior staff regarding protocols, site management/monitoring,etc.*
Assist Clinical management with regulatory submissions, and other reports as required.*
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
Draft informed consents with supervision from line manager.*

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