The Sr. CRA will assist in the development, implementation and execution of study protocols and associated study documents for clinical trials and marketing studies, with primary emphasis on monitoring oversight of Investigational Device Exemption (IDE) clinical trials, including development of monitoring plans and review of all monitoring reports. The Sr. CRA will assist in the clinical monitoring of all company studies, including the coordination of site activities from site start-up to site closure as needed. The Sr. CRA will work closely with the Clinical Project Managers to ensure the study is executed to meet project deliverables.

The Sr. CRA will contribute to the protocol design, informed consent development, Case Report Form (CRF) design, participate in electronic data capture (EDC) development and testing, preparation of site-specific logs/documentation and investigator study files. Participate in study design review meetings and attend scientific meetings and industry conference as required. The Sr. CRA will conduct clinical site monitoring visits as needed.

Company Profile

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

Primary Responsibilities:

• Assist Clinical Project Managers in project coordination, planning and logistics, including overview of budget and timelines.
• Present information at investigator meetings as needed.
• Provide daily oversight of all CRAs.
• Develop clinical monitoring plans and assist in development of associated study documents (Safety Monitoring Plans, Data Management Plans, and Informed Consents).
• Assist CRAs in identification of site issues/problems, and associated root causes, and development action plans to ensure resolution, including escalation of appropriate issues in a timely manner.
• Act as the main line of communication between the project manager and the CRA.
• Conduct clinical site qualification, initiation, interim, and close-out monitoring visits as needed.
• Review and approval of monitoring reports and follow up letters.
• Verify that all research staff and facilities have adequate qualifications and resources and are maintained throughout the course of the clinical study.
• Verify that the investigator and research staff follow the approved protocol, all applicable regulations and procedures.
• Ensure adverse events, concomitant medications, and inter-current illnesses are reported in accordance with the protocol on the Case Report Forms (CRFS).
• Communicate deviations from the protocol, Standard Operating Procedure (SOPs), Work Instructions (WI), CFRs, ICH-GCPs, and any other applicable requirements to the investigator and ensure corrective action is implemented.
• Review queries and assist in the resolution of Data Correction Forms (DCFs).
• Participate in project team meetings.
• Participate in departmental development initiatives (e.g., training, SOP development/updates, etc.)
• Provide aid and expertise during any Food and Drug Administration (FDA) audits (study sites or company site).
• Serve as Lead CRA (LCRA) for projects.

Basic Qualifications:

• Bachelor’s degree in a science or related technical field including 4 plus years as an on-site CRA (including pre-study, initiation, interim monitoring and closeout visits).
• Lead or Sr. CRA for clinical trial along with management experience of a team of CRAs on project
• Comprehensive knowledge of ICH-GCPs, CFRs, FDA and other applicable regulations such as ISO Standards 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.
• Strong attention to detail and an ability to prioritize and juggle multiple/competing issues.
• Experience in resource management.
• Ability to create and manage key internal and external partnerships.
• Excellent written and verbal communication skills.
  • Ability to travel 25%.

Preferred Qualifications:

• Experience with medical device and/or complex clinical trials desired but not required.
• Prior experience with cardiovascular clinical trials.
• Understanding of basic anatomy and physiology, electrophysiology and arrhythmias.
• Project Management experience.
• Certified CRA (CCRA) or Certified Clinical Research Professional (CCRP).