Clinical Research Associate I (CRA I)

Location 9165 E Del Camino Dr,Suite 101,Scottsdale, AZ, 85258,United States Other Compensation 5% yearly bonus Employee Type Exempt - FT Position Summary The Clinical Research Associate (CRA) is responsible for overseeing and monitoring clinical trials conducted at CND’s Clinical Research Center site and investigator sites sponsored by CND or in collaboration with external partners. This role ensures that studies are executed in compliance with study protocols, Good Clinical Practice (GCP) R3 guidelines, budget constraints, and established milestone timelines. The CRA must have a strong understanding of clinical trial methodologies, regulatory requirements, and the ability to collaborate effectively with the investigators and internal and external cross-functional teams. The CRA consistently upholds the highest standards of professionalism. Job Responsibilities Regulatory Compliance: Ensure all clinical trials are conducted in adherence to the study protocol, ICH-GCP guidelines, relevant regulations and SOPs. Manage central IRB tasks for participating sites from start-up through close-out. CND Site Subject Visits : Assist providers with subject recruitment, scheduling and conducting site visits at the internal CND site as needed. Responsibilities may include obtaining informed consent (ICF), assessing inclusion/exclusion criteria, recording vitals, and performing blood draws as backup to CND CRC. Site Initiation: Conduct site initiation visits remotely or in person to assess site readiness, including regulatory start-up, facility reviews, annual bio-calibrations, supply storage, staff qualifications and training, study procedures and data entry management. Ensure all required site documents are collected and tracked in compliance with regulatory requirements and internal Standard Operating Procedures (SOPs). May also involve updating clinicaltrials.gov with site-specific information. Study Monitoring: Perform regular site monitoring visits remotely (via eCRF) or in person (via site source documents) per study-specific monitoring plans and timelines. Oversee data entry, protocol adherence, query resolution, quality compliance, and patient safety reporting, escalating protocol deviations or subject safety concerns as needed. Assist in the development of study-specific monitoring plans. Site Communication: Maintain proactive communication with site staff, responding to inquiries timely and escalating urgent matters as necessary. Site Engagement and Subject Recruitment: Monitoring weekly site recruitment logs to verify subject eligibility and enrollment. Assist sites with IRB approvals for advertising and recruitment strategies. Support community patient advocacy outreach when needed. Site Invoices: Review and approve site invoices based on completed EDC data entry and query resolution for all subject visits invoiced, including start-up and close-out visits. Data Management: Oversee the collection, processing, and documentation of study data. Ensure data integrity through thorough data review and timely query resolution following study-specific monitoring plan milestones. Safety Reporting: Oversee the reporting of adverse events and serious adverse events, ensuring compliance with regulatory requirements. Site Close-Out: Conduct site close-out activities to ensure proper data lock, storage, and archiving study documents. Trial Documentation : Maintain and manage all clinical trial documents, ensuring they remain current and compliant with regulatory standards. Team Collaboration: Work closely with internal and external cross-functional teams and vendors to ensure clinical trials are executed efficiently, within budget and in alignment with study milestones. Reporting: Provide regular updates and comprehensive reports to the Senior Director of Clinical Research and/or designated CR lead and other stakeholders on trial progress. Quality Assurance and Compliance Participate in internal and external audits, addressing findings, and implement corrective and preventive actions as necessary. Perform other duties as assigned. Knowledge, Skills & Experience Minimum of 5 years of clinical research experience as a Clinical Research Coordinator or at least 2 years of experience as a Clinical Research Associate. Therapeutic experience in neurology is highly preferred. Experience in Phase I, II or III of clinical trials; familiarity with NIH and other government-sponsored protocols a plus. In-depth knowledge of ICH-GCP guidelines and relevant regulatory requirements for clinical trial conduct. Strong proficiency in IT tools including the MS 365 suite, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and other applicable technologies. Excellent written and verbal communication skills. Strong multitasking skills, attention to detail, creative problem-solving, and the ability to maintain accurate records. Demonstratedability to identify and resolve site-related challenges with strong negotiation skills. Proven ability to work effectively in a team-based environment. Willingness and ability to travel to clinical sites as needed. Education, Certifications, and Licensures Bachelor’s of Science degree or related field required. The Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) certification, or its equivalent, or willing to complete within first month of hire. International Air Transport Association (IATA) certification, if indicated Other Combination of seated and standing work to complete the core functions of the role Sit and stand for long periods of time Visual acuity and analytical skills This job will be expected to work onsite at CND’s Scottsdale, AZ headquarters 3-5 days/week Summary Grow Your Career With Us CND Life Sciences is a patientand employee-centric, future-focused organization. We know there is a patient hoping for answers behind every Syn-One test we perform, and this knowledge drives us day in and day out to be our best. We are dedicated, driven, and passionate with a strong sense of community and team spirit. CND offersplenty of advancement opportunities andexcellent benefitsto include medical, dental and vision, STD, LTD, Life, AD&D, and 401K with an employer match and encourages a positive work life balance. Benefits medical dental and vision STD LTD Life AD&D 401K with an employer match Our Mission Since our founding, CND Life Sciences has been on a mission to advance the care of patients who face the potential diagnosis of a neurodegenerative disease. With long careers in research and clinical care, our foundersset out to unlockdeeper stories within the skin bydetecting key pathological markers in the peripheral nervous system that had been previously out of reach. Our Core Values Great science. It’s the foundation of everything we do. Patients first. There is a patient hoping for answers behind every test we perform – we never forget that. Clinician-minded. We are founded by physicians and dedicated to helping clinicians care for patients – we embrace this responsibility. Quality core. We adhere to high laboratory standards and quality practices – it’s the only way to operate. Always thinking. We are relentless in determining how we can innovate and do better – it’s just in our DNA. Respect. We hold our employees, customers, partners, and suppliers in high regard – we succeed when we are aligned. CND Life Sciences is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status. #J-18808-Ljbffr Kids for the Future