The Clinical Research Associate II (CRA II) will be a key contributor to client’s clinical affairs department and primarily responsible for the site management of assigned clinical investigative sites.  The CRA II will assist with the implementation and execution of study protocols and associated study documents for clinical trials, including clinical monitoring of company studies.   This also includes the coordination of site activities from site start-up to site closure as needed. The CRA II will work closely with the Clinical Project Managers and Sr. CRAs to ensure the study is executed to meet project deliverables.

The CRA II will be responsible for the study start up process for client’s Clinical Investigational protocols, which includes and is not limited to the following: protocol review, Informed Consent Development, CRF design, EDC testing, preparation of site-specific logs/documentation and investigator study files. The CRA II will participate as needed, in study review meetings and attend scientific meetings and industry conferences as required. The CRA II will also conduct site visits including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close Out Visits.

Company Profile

Client is a smaller medical device company that provides innovative technologies for the treatment of Atrial Fibrillation.

Primary Duties and Responsibilities:

• Assist Clinical Project Managers and Sr. CRAs in the study development and start-up process development of the informed consent form and internal review prior to submission to the IRB/EC.  Collection of startup documentation from clinical investigational site 
•  Verify that the investigator and research staff follow the approved protocol and all GCP procedures
• Conduct weekly maintenance and management of study sites to ensure site compliance with study protocol, GCP/ICH, and applicable regulations
• Conduct initial and ongoing study training of site personnel throughout the clinical study
• Monitor and report to ATRC site enrollment activities
• Verify that all research staff and facilities have adequate resources and qualifications and are maintained throughout the course of the study
• Assist with the preparation of clinical study devices and verify the accountability of investigational devices are properly received, tracked, and secured at the study site
•  Ensure adverse events, concomitant medications, and inter-current illnesses are reported in accordance with the protocol on the CRF.
•  Communicate deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and   ensure corrective action is implemented.
•  Review queries and assist in the resolution of DCFs.
•  Participate in project team meetings.
• Participate in departmental development initiatives (e.g. training, SOP development/updates, etc.)
• Ability to work on multiple projects as departmental priorities change

Basic Qualifications:

• Bachelor’s degree in a science or related technical field required or demonstrated equivalent combination of education, training and experience
• Minimum two years of CRA experience
• Comprehensive knowledge of ISO, GCP, ICH, FDA and other applicable regulations governing the conduct of clinical trials
• Ability to manage role/responsibility independently.
• Recognize problems, trends and react to resolve issue quickly and to bring effect resolution.
• Experience working with electronic data capture systems
• Strong attention to detail and an ability to prioritize and juggle multiple/competing issues.
• Ability to create and manage key internal and external partnerships.
• Excellent written and verbal communication skills.
• Experienced user Microsoft Office software including WORD, Excel, and PowerPoint
• Ability to travel up to 50%

Preferred Qualifications:

• Experience with medical device clinical trials desired but not required.
• Prior experience with cardiovascular clinical trials.
• Understanding of basic anatomy and physiology, electrophysiology and arrhythmias
• Registered Nurse with previous clinical research experience as either a CRA or Study Coordinator.
• CCRA or CCRP Certification