# Clinical Research Coordinator **Company**: IQVIA **Experience**: mid **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Wilayah-Persekutuan-Kuala-Lumpur-Malaysia/Site-Activation-Specialist_R1521961?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_be305698-9d0 ## Description We are seeking a Clinical Research Coordinator to join our team. As a Clinical Research Coordinator, you will be responsible for performing feasibility, site identification, site contract negotiation, and other study start-up activities. You will also provide country-specific study start-up expertise to study start-up team leads and project teams. Responsibilities: - Perform feasibility, site identification, site contract negotiation, and other study start-up activities, as assigned - Distribute and collect CDAs for potential study sites - Provide country-specific study start-up expertise to study start-up team leads and project teams - Create study start-up document templates - Prepare and coordinate submissions to regulatory, ethics, and other bodies - Develop, finalize, and review master and country-specific subject information sheets (SIS)/ICFs - Review and translate drug labels - Perform independent quality review of submission packages - Coordinate and translate documents required for submission - Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS - Copy and route incoming correspondence, internal documentation, etc, as appropriate - Follow-up for queries made by EC/competent authority (CA) - Coordinate and create documents and material needed to support SIV - Collect critical documents required for IP release - Dispatch, negotiate, execute, and track contracts with sites and other sites, as appropriate - Attend study team meetings as required, including Kick-Off Meeting - Collect and maintain current regulatory/CA and EC submission information and similar information for other related organizations in the assigned countries - Update relevant information system - Familiarize yourself with ICH GCP, relevant country regulations/guidelines, and SOPs - Demonstrate competent communication and influencing skills to ensure timely follow-up, issue resolution, and report updates - Perform regulatory document maintenance; amendments, periodic updates, and safety letters, where applicable - Develop and maintain effective relationships with local, regional, and country authorities - Comply with all department requirements regarding information provision and status updating and reporting - Undertake other reasonably related duties as may be assigned from time to time Requirements: - Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience - In-depth knowledge of clinical systems, procedures, and corporate standards - Good negotiating and communication skills with ability to challenge, if applicable - Effective communication, organizational, and interpersonal skills - Ability to work independently and to effectively prioritize tasks - Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines - Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards - Understanding of regulated clinical trial environment and knowledge of drug development process - Ability to establish and maintain effective working relationships with coworkers, managers and clients ## Skills ### Required - GCP/ICH - clinical research - regulatory guidelines - communication - influencing skills - organizational skills - interpersonal skills --- Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Wilayah-Persekutuan-Kuala-Lumpur-Malaysia/Site-Activation-Specialist_R1521961?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)