What are the responsibilities and job description for the Clinical Research Coordinator position at Koncord Clinical Research Services?
Job Summary
We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our dynamic research team. In this vital role, you will oversee the planning, execution, and management of clinical trials to ensure compliance with regulatory standards and research protocols. Your proactive approach will facilitate smooth study operations, safeguard participant safety, and uphold the integrity of data collection and documentation. This position offers an exciting opportunity to contribute to groundbreaking healthcare research while developing your expertise in clinical development and regulatory compliance.
Duties
- Coordinate all aspects of clinical trials, including participant recruitment, enrollment, and retention, ensuring adherence to study protocols and ethical guidelines.
- Monitor patient progress throughout the study, including administering assessments, collecting samples such as blood or other specimens, and documenting clinical observations accurately.
- Review and verify all study documentation for completeness, accuracy, and compliance with FDA regulations, ICH GCP standards, and healthcare privacy laws such as HIPAA.
- Manage data entry and data management activities utilizing electronic medical record (EMR) systems and adhere to CDISC standards for data collection and reporting.
- Supervise research staff and collaborate with investigators to ensure project milestones are met efficiently while maintaining high-quality standards.
- Conduct regular quality assurance checks in accordance with clinical trials management protocols and clinical laboratory experience requirements.
- Prepare reports, maintain detailed records of study activities, and assist in regulatory submissions to ensure ongoing compliance with clinical research regulations.
Qualifications
- Proven supervising experience in a clinical research or healthcare setting with a strong understanding of project management principles.
- Knowledge of medical terminology, clinical research methods, FDA regulations, ICH GCP guidelines, and healthcare compliance standards.
- Experience reviewing documentation for accuracy and completeness; familiarity with data management tools such as statistical software is preferred.
- Ability to monitor patients effectively, including blood sampling procedures and assessment of clinical trial participants’ safety.
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) along with EMR systems; experience with clinical quality assurance standards is advantageous.
- Certification in Good Clinical Practice (GCP) from a recognized issuer (e.g., ICH GCP certificate) is required; valid certification for CA or equivalent is preferred.
- Strong analysis skills combined with knowledge of CDISC standards for data collection; familiarity with clinical laboratory procedures enhances your suitability.
- Excellent organizational skills with experience managing multiple projects within a research setting while ensuring compliance with all ethical guidelines including HIPAA and clinical ethical standards.
Join us in advancing healthcare through innovative research! This paid position offers an engaging environment where your expertise will directly impact patient outcomes while fostering your professional growth in clinical development and research project management.
Pay: $25.00 - $30.00 per hour
Work Location: In person
Salary : $25 - $30