This position is responsible for the initiation and independent oversight of clinical centers to ensure the successful conduct of active clinical studies. The Clinical Research Associate will ensure that clinical centers perform the clinical study according to the study protocol and regulatory standards by qualifying, training, monitoring, and overseeing study conduct at multiple clinical centers.
MAIN DUTIES/RESPONSIBILITIES
Identify and assess the suitability of clinical study centers for participation in Inspire clinical trials.
Serve as a primary point of contact for study sites, investigators, and other stakeholders.
Train clinical centers on the clinical study protocol, data collection and good clinical practices.
Communicate directly with clinical centers to maximize enrollment, ensure quality and timely data capture and answer study-related questions.
Perform remote and on-site monitoring visits at participating clinical study centers to ensure the safety of study patients, the reporting of accurate study data and appropriate study management at the clinical study center. Ability to travel up to approximately 30% is required.
Document site visits by preparing visit reports and follow-up letters to the clinical study centers.
Facilitate effective communication and collaboration among study team members.
Assist clinical centers with the preparation of IRB/EC submissions.
Collect and archive study related documentation and correspondence.
Communicate monitoring and site management updates to the internal clinical team.
Assist with the development of the clinical study Monitoring Plan.
Develop training materials and other study-related documentation.
Maintain clinical monitoring tracking tools for each clinical study.
Assist with other clinical related duties as assigned.
QUALIFICATIONS
Educational Requirements:
High School Diploma or GED required
Bachelor's Degree (BA or BS) preferred
Science Degree preferred
Required Experience:
Previous experience in clinical research (minimum 3 years)
Understanding of GCP and 21 CFR 812
Experience with clinical documentation, clinical data and institutional review boards