Clinical Research Associate

2 weeks ago

Lexington, United States System One Full time

Remote - Bethesda, MD area (candidates in DC and Northern, VA will also be considered) Title: Clinical Research Associate Start Date - 07/06/2024 End Date - 07/06/2025 Summary: This is a fully remote opportunity with the successful candidate being in the Bethesda, MD area (candidates in DC and Northern, VA will also be considered). All site visits will be in Bethesda, MD location. JOB DESCRIPTION: Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of interim and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. This is a contract traveling CRA position if necessary. Assists with effective and timely audit/inspection responses. Prepares key reports and documents on progress of study for study manager. Tracks study specific tasks and progress of the trial. Reviews study and/or site specific ICF(s) for compliance with ICH/GCP and company SOPs. Knowledge, Skills and Abilities: Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Good knowledge of therapeutic area assigned; oncology Preferred experience working with NCI Strong knowledge of ICH/GCP Guidelines and EDC process. Ability to establish rapport with site personnel/ colleague. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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