Description:
We are seeking an experienced Clinical Research Coordinator (CRC) to support an ongoing clinical study through data entry, query resolution, and a variety of site coordination activities.
The ideal candidate has prior CRC experience, a collaborative mindset, and the ability to work effectively with diverse stakeholders. Success in this role requires strong interpersonal skills, adaptability, diplomacy, and attention to detail.
Essential Responsibilities
- Conduct clinical studies in compliance with FDA, ICH-GCP, and applicable regulatory guidelines.
- Record patient information and test results accurately according to study protocols.
- Maintain investigational product (IP) accountability logs and related documentation, when required.
- Identify and report suspected protocol or regulatory non-compliance to appropriate site personnel.
- Ensure IRB approval is obtained before study initiation and maintain ongoing IRB compliance throughout the study.
- Build positive relationships with patients to support engagement and retention.
- Attend site initiation visits and protocol training sessions.
- Schedule patients and conduct appointment confirmation and follow-up calls, as needed.
- Complete and maintain sponsor documentation in EDC, case report forms (CRFs), and other clinical systems within required timelines.
- Organize and maintain source documents, patient files, and study records with accurate and up-to-date information.
- Follow established SOPs and clinical operating procedures.
- Assist in maintaining a clean, organized, and compliant clinical environment, including proper waste disposal when applicable.
Required Qualifications
- Bachelor's degree or an equivalent qualification in a clinical, medical, or related healthcare field.
- Minimum 2 years of experience as a Clinical Research Coordinator or in a comparable clinical research role.
Knowledge, Skills & Abilities
- Strong understanding of clinical research processes, including GCP, SOPs, informed consent, and safety monitoring.
- Ability to work independently while managing multiple priorities with strong attention to detail.
- Sound judgment and discretion when handling sensitive and complex information.
- Effective problem-solving, decision-making, negotiation, and influencing skills.
- Strong verbal and written communication skills; English proficiency is an asset.
- Excellent organizational and time management abilities.
- Proficiency with basic computer applications and electronic data capture (EDC) systems.
- Strong interpersonal skills and the ability to collaborate within a multidisciplinary team