Clinical Research Associate - Oncology - MD, VA or D.C. - FSP - (, , United States)

The Clinical Research Associate is responsible for the following: • Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites Key Accountabilities:  Site Management Responsibilities  Supporting Activities may include but not limited to the following  - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial  - Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents  - Gains an in-depth understanding of the study protocol and related procedures  - Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready  - Participates and provides inputs on site selection and validation activities  - Performs remote and on-site monitoring & oversight activities using various tools to ensure:  - Data generated at site are complete, accurate and unbiased  - Subjects’ right, safety and well-being are protected  - Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner  - Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out  - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance  - Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager  - Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines  Team Development and Support  - Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required  - Supports and/or leads audits/inspection activities as needed  - Performs co-monitoring visits where appropriate  Skills:  - Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively  - Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines  - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines  - Hands on knowledge of Good Documentation Practices  - Proven skills in Site Management including management of site performance and patient recruitment  - Demonstrated high level of monitoring skill with independent professional judgement  - Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices  - Ability to understand and analyze data/metrics and act appropriately  - Capable of managing complex issues, working solution-oriented manner  - Performs root cause analysis and implements preventative and corrective action  - Effective time management, organizational and interpersonal skills, conflict management, problem solving skills  - Demonstrated high level of monitoring skill with independent professional judgement  - Able to work highly independently across multiple protocols, sites, and therapy areas  - High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.  - Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.  - Demonstrates commitment to Customer focus  - Works with high quality and compliance mindset  - Positive mindset, growth mindset, capable of working independently and being self-driven  - Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices  - Ability to travel domestically and internationally approximately 65%-75% of working time  - Expected travelling ~2-3 days/week  - Current driver’s license required  Knowledge and Experience:   - Minimum 2 years of direct site monitoring experience in bio/pharma/CRO  - Oncology monitoring experience required Education:  - Bachelor’s degree preferred with a strong emphasis in science and /or biology    #LI-LO1 #LI-REMOTE