The Clinical Research Associate II (CRA II) will be a key contributor to AtriCure’s clinical affairs department and primarily responsible for the site management of assigned clinical investigative sites.
Locations (2)
Mason, Ohio, United States
Minnetonka, Minnesota, United States
Compensation
US Pay Range
$85,000—$105,000 USD
Responsibilities
Assist Clinical Project Managers and Sr. CRAs in the study development and start-up process
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
Requirements
Bachelor’s degree in a science or related technical field
Clinical Research Associate I responsible for site qualification, monitoring, data review, and regulatory compliance across multiple clinical sites, working both on‑site and remotely.
Responsibilities
Perform site qualification, initiation, monitoring, and close‑out visits
Evaluate site performance and provide recommendations
Verify informed consent procedures
Assess safety and data integrity
Conduct source document review and query resolution
Requirements
Bachelor’s degree or RN in a related field or equivalent
Supports the conduct of clinical research studies by coordinating day‑to‑day trial activities, ensuring regulatory compliance, and serving as a key liaison between investigators, sponsors, and study participants.
Responsibilities
Coordinate and manage assigned clinical trials from study start‑up through close‑out
Screen, recruit, and enroll eligible study participants according to protocol criteria
Obtain and document informed consent in compliance with regulatory requirements
Schedule and conduct study visits, assessments, and procedures per protocol
Collect, review, and enter study data accurately and timely into electronic data capture systems
Requirements
Degree in health sciences
Degree in nursing
Degree in biology
Related field degree
Nice to have: Certified Clinical Research Coordinator (CCRC)
Support clinical and translational research in the Division of Allergy and Immunology, managing study conduct, regulatory compliance, recruitment, data management, and coordination with investigators and sponsors.
Lead site monitoring and support for clinical trials across Spain, ensuring compliance with GCP, regulations, and SOPs.
Responsibilities
Lead site qualification, initiation, interim monitoring, management, and close-out activities
Protect patient safety and data integrity by reviewing informed consent, safety information, source documents, CRFs, and resolving queries
Guide sites in protocol adherence, Investigator Site File maintenance, regulatory and ethics documentation, investigational product accountability
Coordinate CRAs as a Lead CRA on global studies, providing mentoring, training, and practical guidance
Partner with Project Management and study teams to evaluate deliverables, milestones, site performance, and monitoring activities
Requirements
MD or Pharmacy qualification (MSPH, PharmD, PhD, equivalent Pharmacy degree, or similar) with at least 3 years CRA experience
Minimum four-year college curriculum in medical, biological, physical, health, pharmacy, or another related science with at least 5 years CRA experience
Two-year college curriculum or equivalent education/training, preferably nursing or equivalent life science degree, with at least 7 years CRA experience
Assist with the day-to-day conduct of industry-sponsored clinical trials and support all aspects of trial operations under the direction of the Principal Investigator and Lead Clinical Research Coordinator.
Compensation
Salary: $60,000 - $65,000 USD
Responsibilities
Assist with the day-to-day conduct of industry-sponsored clinical trials
Review study protocols and prepare for participant visits
Support participant recruitment, prescreening, scheduling, and retention
Assist with the informed consent process within the scope of training and delegation
Assist with study visit procedures within the scope of training and delegation
Requirements
Bachelor's or higher in life sciences, healthcare, nursing, or related field
Nice to have: Degree or certificate in life sciences, healthcare, nursing, or related field
Nice to have: Medical Assistant, LPN, RN, phlebotomy, or other relevant clinical training
Nice to have: More than one year of professional clinical research experience
Nice to have: Experience with industry-sponsored Phase II–IV clinical trials
Clinical Coordinators perform clinical research related functions including research conducted with human subjects focusing on mechanisms of disease, therapeutic interventions, clinical trials, or development of new technologies.
Responsibilities
Perform day-to-day operations of clinical trials and studies
Obtain medical history from consented participants, including follow-up for off-site medical records and completion of a participant health survey
Obtain informed consent and/or assent from study participants and ensure that the process is properly documented, and that informed consent form documents are filed as required
Schedule subject participation in research clinical trials and coordinate the availability of necessary space and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
Adhere to research regulatory standards
Requirements
Bachelor’s degree in any field from an accredited institution
Nice to have: Bachelor’s degree in science or health related field
Nice to have: Experience working with individuals with Down syndrome or other intellectual disability
Nice to have: Electronic data capture systems (REDCap, EDC systems, electronic health records)
Nice to have: Data review, validation, query resolution, and data cleaning
Assist in coordinating studies by preparing personnel and materials, protocols, informed consents, amendments and other necessary documents for review by the IRB and Sponsor
Assemble lab kits and/or gather supplies
Collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedure (SOP) or other work instruction set
Ensure specimens are properly logged, handled and stored
Follow direction of clinical research coordinator or others involved in the clinical research project work
Requirements
High school diploma or equivalent
Bachelor's degree in a related field
Master's degree in a related field
Nice to have: Bachelor's degree in a related field