Clinical Research Site Coordinator

Benefits

Qualifications

• •We are looking for someone who has experience with feasibility, and site selection process, and is comfortable with regulatory
• •We are eager to discover an individual who possesses ambition, boasts a history of leadership and teamwork, and resonates with Paradigm's core values of honesty, credibility, transparency, innovation, and growth
• •Strong understanding of Good Clinical Practice and clinical research methodologies
• •Proven experience in managing clinical trials and supervising research teams
• •Proficiency in data collection and management, including EMR systems
• •Familiarity with FDA regulations and clinical documentation review
• •Knowledge of medical terminology and patient monitoring techniques
• •Ability to analyze data and ensure compliance with CDISC standards and HIPAA regulations
• •5 more items(s)

Responsibilities

• •In this position you will conduct and manage clinical trials according to study protocols, collect clinical data points, and provide exceptional customer service to people participating in our clinical research studies
• •This person will be instrumental in continuing to bring this site to its full potential
• •Oversight of Clinical Trials: Ensure that all clinical trials are conducted in accordance with the study protocol and regulatory requirements
• •Team Leadership: Lead, mentor, and provide direction to the research site team to ensure efficient operations
• •Patient Safety: Prioritize and ensure the safety and well-being of all study participants
• •Regulatory Compliance: Stay updated with regulatory guidelines and ensure the site's adherence to them
• •Data Management: Oversee accurate data collection, entry, and timely reporting to sponsors
• •Stakeholder Communication: Maintain open lines of communication with sponsors, investigators, and other key stakeholders
• •Resource Allocation: Ensure optimal allocation and utilization of resources, including equipment, supplies, and personnel
• •Training & Development: Ensure that all staff members are adequately trained and updated on the latest clinical research practices and guidelines
• •Site Audits: Prepare for and facilitate internal and external audits, ensuring any findings are addressed promptly
• •Continuous Improvement: Implement best practices and continuous improvement initiatives to enhance the efficiency and quality of research conducted at the site
• •Study Feasibility & Start-Up: Evaluate the feasibility of potential studies for the site, ensuring alignment with site capabilities, and oversee the efficient start-up of new trials, including site initiation and patient recruitment strategies
• •Job Type: Full-time
• •11 more items(s)