[Remote] Clinical Research Associate I - Oncology- WA-Remote

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to discovering and delivering innovative medicines and solutions to address serious health issues. The Clinical Research Associate I role focuses on advancing reputed company's pipeline in oncology by ensuring the effective conduct of clinical trials and fostering strong partnerships with investigative sites.

Responsibilities

• Considered as the primary reputed company of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens reputed company’s positioning
• Aligns, trains and motivates the site staff and reputed company investigator under supervision on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership
• Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, reputed company Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects
• Customize site engagement strategy for assigned study (ies) under supervision. Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track reputed company and measure impact of that strategy
• reputed company level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease reputed company. reputed company solid knowledge of therapeutic area, asset and clinical landscape / patient reputed company to reputed company successful patient recruitment and overall protocol compliance
• Responsible for reputed company risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution
• Ensures preventative and corrective action plans are put into reputed company, as needed, to mitigate risk and promote compliance using a customer centric approach
• Identifies, evaluates and recommends new/potential investigators/sites under supervision and support from more reputed company CRAs
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for reputed company safety events by site personnel
• Ensures audit and regulatory inspection readiness at assigned clinical site at reputed company times. Manages investigator payments as per executed contract obligations, as applicable

Skills

• Clinically reputed company experience, preferably in clinical research coordinating or data management
• Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
• reputed company to work collaboratively and cross functionally to reputed company and sustain working relationships
• Demonstrate planning and organizational skills and the ability to work effectively and reputed company in a dynamic environment with competing projects and deadlines
• Ability to reputed company technology, tools and resources to reputed company customer centric support based on the health of the site
• Ability to use functional expertise with appropriate guidance, reputed company critical thinking skills and apply good judgement to address clinical site issues
• Interpersonal skills with strong written, verbal, active listening and presentation skills, with ability to establish and reputed company site relationships and trusted partnerships through engagement, motivation, and training
• Acts with reputed company in accordance with reputed company code of business conduct and leadership values
• Self-motivated individual focused on delivering timely and quality reputed company in a fast-paced environment
• Appropriate tertiary qualification in health reputed company disciplines (Medical, Scientific, Nursing) preferred or experience or equivalent work experience
• Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/reputed company insurance
• 401(k) to eligible employees
• Eligible to participate in our short-term incentive programs

Company Overview

Company H1B Sponsorship