Freelance Clinical Research Associate
About the position The Freelance Clinical Research Associate at ClinChoice is responsible for managing clinical trial sites, both on-site and remotely, primarily across the Midwest and West Coast. This role involves monitoring clinical studies, ensuring compliance with protocols, and maintaining high-quality clinical data. The position requires experience in oncology and respiratory trials, and the successful candidate will work closely with various stakeholders to ensure the smooth execution of clinical projects. Responsibilities • Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to assigned clinical projects. • Assist in the selection of sites, site evaluation visits, initiation visits, and ensure follow-up by obtaining pre-study documentation. • May act as Feasibility Associate (FEA) after appropriate training. • Train site staff in all study procedures to ensure protocol/ICH-GCP compliance. • Conduct and report periodic monitoring visits, reviewing accuracy, legibility, completeness, and quality of Case Report Forms (CRFs). • Attend and may present at Investigator Meetings and study-specific training meetings. • Conduct source data verification and in-house review of clinical data, ensuring timely resolution of data queries. • Manage investigational products and trial materials to ensure timely and correct supply to the site. • Cooperate with site staff to ensure proper reporting of safety issues and their follow-up. • Conduct and report study termination and related activities, ensuring smooth project completion. • Serve as the main contact person for the site to ensure close follow-up. • Provide general support to Clinical Operations - NA on quality control of clinical data. • Promptly address issues with Project Coordinators, Project Managers, and Senior Project Managers that may jeopardize clinical projects. • Report to the Clinical Operations Director or delegate on all activities performed during the study. • Develop training material and provide training to Clinical Operations - NA in collaboration with the Training & Qualification Management Unit. • Assist in contract negotiation with sites on study budget after appropriate training. • Assist in the preparation of the study including CRF design/development and organizing study files. • Support the submission process in the project, including submission requirements and informed consent development. • Guide and supervise Clinical Research Associates I and II to coach and train them on the job. • Perform co-visits with Clinical Research Associates I and II. Requirements • Bachelor's Degree or equivalent in scientific, medical, or paramedical disciplines; Nursing degree preferred. • At least 8 years of experience as a Clinical Research Associate (CRA). • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines, and applicable regulatory requirements. • Sound knowledge of medical terminology. • Ability to manage multiple studies simultaneously. • Fluent in English and local languages. • Proficiency in Microsoft Office (Word, Excel, Outlook). • Willingness and ability to travel up to 50-80%, depending on project needs. Nice-to-haves • Experience in oncology and respiratory trials. • Experience with contract negotiation and site budget management. Benefits • Competitive salary • Flexible working hours • Opportunity for professional development • Work-life balance • Collaborative team culture Apply tot his job