Freelance Clinical Research Associate

About the position 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 Apply To this Job