Clinical Trial Specialist

Job Title: Clinical Research AssociateAbout the Job We are seeking a skilled Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. Key Responsibilities Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel, and study close out. Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance with applicable regulations. Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and SOPs. Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables. Verifies proper management and accountability of Investigational Product (IP). Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate. Manages essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assists with resolution of investigational site/data queries. Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation. Participates in audit preparation and follow-up activities as needed. Independently performs a variety of onsite and offsite monitoring visit types. Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate. Assists with non-complex ad-hoc, short-term assignments in support of additional studies or departmental initiatives. May serve as preceptor, providing training to less experienced clinical team members. Undergraduate degree or international equivalent in clinical, science, or healthcare-related field from an accredited institution; healthcare professional licensure, i.e., registered nurse. Previous experience supporting clinical trials, including solid on-site monitoring experience in CROs or pharma companies. Travel is required 50-80%. All employees must read, write, and speak fluent English and host country language. Required Skills and Qualifications The ideal candidate will possess: An undergraduate degree or international equivalent in a clinical, science, or healthcare-related field from an accredited institution; Healthcare professional licensure, i.e., registered nurse; Previous experience supporting clinical trials, including solid on-site monitoring experience in CROs or pharma companies; Strong analytical and problem-solving skills; Excellent communication and interpersonal skills; Ability to work independently and collaboratively as part of a team; Proficiency in Microsoft Office Suite, particularly Excel, Word, and PowerPoint; Familiarity with electronic data capture systems and clinical trial management software; Fluency in English and host country language. What We Can Offer You At (Company Name), we offer a competitive salary and a range of additional benefits to support your career growth and well-being. Our benefits package includes: A comprehensive health insurance plan; A retirement savings plan with company match; Flexible paid time off policy; Professional development opportunities; A diverse and inclusive work environment. Why Work with Us At (Company Name), we value diversity, equity, and inclusion in our workplace. We strive to create a culture where everyone feels welcome, valued, and empowered to contribute their best work. If you share our commitment to these values, we encourage you to apply.