Job Title: Clinical Research Associate II - Sponsor Dedicated
We are seeking a detail-oriented and organized individual to join our team as a Clinical Research Associate II - Sponsor Dedicated.
This role involves conducting on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices.
The successful candidate will review study protocols, informed consent forms, and case report forms, as well as develop and implement tools, procedures, and processes to ensure quality monitoring.
In addition, the CRA II will contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials.
Key responsibilities include managing defined components of projects or processes within the area of responsibility, ensuring accurate and timely documentation of monitoring activities and findings, and collaborating with cross-functional teams to support clinical trial operations.
Requirements:
* Bachelor's degree in a related field or equivalent experience
* Minimum of 2-4 years of experience in clinical research monitoring
* Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
* Excellent communication and interpersonal skills
* Ability to work independently and manage multiple priorities
* Proficiency in using clinical trial management systems and other relevant software
Preferred Qualifications:
* Certified Clinical Research Associate (CCRA) or equivalent certification
* Attention to detail and strong analytical skills
* Problem-solving abilities and critical thinking
* Ability to work effectively in a team environment
* Strong organizational and time management skills
* Proficiency in Microsoft Office Suite