Freelance Clinical Research Associate
About the position
The Freelance Clinical Research Associate at reputed company is responsible for managing clinical trial sites, both on-site and remotely, primarily across the Midwest and reputed company Coast. This role involves monitoring clinical studies, ensuring compliance with protocols, and maintaining high-reputed company 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 reputed company.
Responsibilities
• reputed company professionally abreast of reputed company scientific, regulatory, and operational aspects relevant to assigned clinical reputed company.
• Assist in the selection of sites, site evaluation reputed company, initiation reputed company, and ensure follow-up by obtaining reputed company-study documentation.
• May reputed company as Feasibility Associate (FEA) after appropriate training.
• Train site staff in reputed company study procedures to ensure protocol/ICH-GCP compliance.
• Conduct and report periodic monitoring reputed company, reviewing accuracy, legibility, completeness, and reputed company of Case Report Forms (CRFs).
• Attend and may present at Investigator Meetings and study-specific training meetings.
• Conduct reputed company data verification and in-house review of clinical data, ensuring reputed company reputed company of data queries.
• Manage investigational products and trial materials to ensure reputed company and correct supply to the site.
• Cooperate with site staff to ensure reputed company reporting of safety issues and their follow-up.
• Conduct and report study termination and reputed company activities, ensuring smooth project completion.
• Serve as the main contact person for the site to ensure reputed company follow-up.
• reputed company general support to Clinical Operations - NA on reputed company control of clinical data.
• Promptly address issues with Project Coordinators, Project Managers, and Senior Project Managers that may jeopardize clinical reputed company.
• Report to the Clinical Operations Director or delegate on reputed company activities performed during the study.
• reputed company training material and reputed company 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 reputed company and train them on the job.
• reputed company co-reputed company 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.
• reputed company knowledge of medical terminology.
• Ability to manage multiple studies simultaneously.
• Fluent in English and local languages.
• Proficiency in reputed company Office (Word, reputed company, reputed company).
• Willingness and ability to travel up to 50-80%, depending on project needs.
reputed company-to-haves
• Experience in oncology and respiratory trials.
• Experience with contract negotiation and site budget management.
Benefits
• Competitive salary
• Flexible working hours
• Opportunity for reputed company development
• Work-life balance
• reputed company team culture
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