Clinical Research Associate II – Contractor

Job Description: • Help to execute assigned clinical studies and ensure studies are completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, SOPs and overall clinical objectives • Daily activities may vary depending on the clinical phase of the program and may support more than one study • Collaborate with contract research organization (CRO) personnel and study sites to ensure studies are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, SOPs and overall clinical objectives • Manage study deliverables, including clinical study start-up activities, clinical supply logistics, enrollment, data collection, and close-out in consultation with study leads • Participate in on-site and remote monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits • Review monitoring visit reports and track resolution of action items • Actively participate in the preparation of study-related clinical documents • Support the selection of sites and CROs and planning of clinical meetings as needed • Assist with the review of clinical trial data and listings • Assist with filing of clinical documents in the TMF, as applicable Requirements: • A BA/BS in Life Sciences or equivalent • 2+ years of clinical research associate experience in the biotechnology industry, sponsor experience preferred • On-site monitoring proficiency required • Deep working knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials • Ability to exercise independent judgment and use critical thinking to analyze problems which may require multiple factors and approaches • Excellent technical writing skills • Experience working in cross-functional project teams • Strong verbal and written communication and interpersonal skills • Computer proficiency a must • Ability to sit for prolonged periods; reach with arms and hands; lift and move small objects; use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers • Occasional travel required, as needed • Integrity and flexibility • Proactive in identifying potential problems and seeking successful solutions • Action- and goal-oriented • Practical approach to clinical and regulatory processes • Collaborative and team-oriented • Excellent attention to detail Benefits: • Highly flexible work environment for headquarter employees • Gather for in-person meetings when necessary