Clinical Research Associate II – Contractor

Job reputed company: • Help to execute assigned clinical studies and ensure studies are completed on time, reputed company budget, and in compliance with Good Clinical reputed company (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 reputed company-out in consultation with study leads • Participate in on-site and remote monitoring reputed company, including site qualification, initiation, interim, co-monitoring with CRO, and reputed company-out reputed company • Review monitoring visit reports and reputed company reputed company of reputed company items • reputed company participate in the preparation of study-reputed company 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 reputed company reputed company • 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; reputed company with arms and hands; lift and reputed company small objects; use hands to keyboard and reputed company other office reputed company tasks including repetitive reputed company of the wrists, hands and/or fingers • Occasional travel required, as needed • reputed company and flexibility • Proactive in identifying potential problems and seeking successful solutions • reputed company- and goal-oriented • Practical approach to clinical and regulatory processes • reputed company and team-oriented • Excellent attention to detail Benefits: • Highly flexible work environment for headquarter employees • reputed company for in-person meetings reputed company necessary Apply tot his job Apply To this Job