Clinical Research Associate (CRA / Sr. CRA)

Job Title: Clinical Research Associate (CRA / Sr. CRA) Location: Remote (Travel Throughout Midwest & East Coast) Length of Assignment: 12+ Months Pay Rate: $50/hr-$66/hr all-in rate (depending on experience) Job Descripion: Seeking experienced CRA and Sr. CRA consultants to support ongoing and upcoming cardiovascular medical device clinical studies. These individuals will serve as the primary owner for assigned sites and be responsible for end-to-end site management including site qualification, initiation, monitoring, closeout activities, regulatory compliance, source data verification, adverse event review, device accountability, and site relationship management. Must Have:

• 5–7+ years of Medical Device CRA experience
• Independent site ownership experience
• Site qualification, initiation, monitoring, and closeout experience
• Ability to perform solo monitoring visits
• ICH-GCP and FDA regulatory knowledge
• Cardiovascular device and/or implantable device study experience
• Strong site relationship management skills

Nice to Have:

• Prior experience supporting cardiovascular clinical trials
• Investigator meeting support
• IRB/EC submission experience
• Site budget and contract experience
• Experience working directly with Medical Affairs, Regulatory Affairs, Quality, and Clinical Operations teams
• Master's Degree in a scientific discipline

Pay: $50.00 - $66.00 per hour Application Question(s):

• Do you have 5+ years of Clinical Research Associate (CRA) experience supporting Medical Device clinical trials?
• Have you independently owned and managed clinical trial sites from qualification through closeout?
• Do you have hands-on experience performing site qualification, site initiation, monitoring, and closeout visits?
• Have you conducted solo monitoring visits without direct supervision?
• Do you have working knowledge of ICH-GCP guidelines and FDA clinical research regulations?
• Do you have experience supporting cardiovascular device and/or implantable medical device studies?
• Have you been responsible for source data verification (SDV), adverse event review, and device accountability activities?
• Do you have experience building and maintaining relationships with investigators, study coordinators, and clinical sites?
• Are you able and willing to travel throughout the Midwest and East Coast for site visits?

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