Orso Health is a leading organization in clinical research, dedicated to advancing healthcare through innovative studies. We are committed to excellence in research and invite you to be part of our dynamic team. California and the Arizona market. Known for our high standard of excellence, we are committed to providing compassionate, patient-centered care for both pediatric and adult patients. Our dedicated team strives to improve lives through the expert diagnosis and treatment of a wide range of allergy and asthma conditions. We are looking for high-energy, kind, and collaborative individuals who are eager to grow personally and professionally to join our team. We are seeking a dedicated and experienced Senior Clinical Research Coordinator (CRC) to join our team. The ideal candidate will play a key role in managing clinical trials across multiple sites, ensuring compliance with regulatory requirements and study protocols while maintaining the highest standards of participant safety and data integrity. The position requires regular travel to study sites, making it essential for the candidate to be adaptable and organized.
Key Responsibilities:
Site Management:
Oversee the day-to-day operations of clinical trials at various sites, ensuring adherence to study protocols, regulatory compliance, and good clinical practice (GCP).
Training & Mentorship:
Provide training and support to junior CRCs and site staff, fostering a collaborative environment and ensuring proficiency in study procedures.
Participant Interaction:
Engage with study participants, including recruitment, informed consent, and addressing any questions or concerns regarding the study process.
Data Collection & Documentation:
Ensure accurate and timely collection, documentation, and reporting of study data in accordance with regulatory guidelines and sponsor requirements.
Regulatory Oversight:
Maintain all necessary regulatory documentation, including IRB submissions, regulatory binders, and serious adverse event (SAE) reporting.
Sponsor & Stakeholder Communication:
Act as the primary point of contact between the sponsor, study sites, and internal teams, facilitating effective communication and resolution of any issues that arise.
Quality Assurance & Compliance:
Participate in site visits and audits, ensuring compliance with all study protocols and regulations.
Qualifications & Requirements:
Education:
Bachelor's degree in a related field (e.g., life sciences, nursing, or similar).
Experience:
Minimum of 5 years of experience in clinical research, with at least 2 years as a Clinical Research Coordinator. Experience in a variety of therapeutic areas is a plus.
Knowledge & Skills:
Strong knowledge of
GCP, FDA
regulations, and clinical trial processes. Excellent organizational skills and attention to detail, with the ability to manage multiple projects simultaneously. Strong communication and interpersonal skills, capable of working collaboratively with diverse teams. Proven ability to work independently and handle challenging situations effectively.
Technology Proficiency:
Proficient in using clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
Travel:
Willingness to travel frequently between sites as required.
Preferred Qualifications:
Certification in clinical research (e.g., ACRP or SOCRA certification).
Benefits:
Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Opportunities for professional development and continuing education.
Job Type:
Full-time Pay:
$36.00 - $40.00 per hour Application Question(s): Do you have a minimum of 5 years of experience in clinical research, with at least 2 years as a Clinical Research Coordinator? Do you have a willingness to travel frequently between sites? Do you hold a Certification in clinical research (e.g., ACRP or SOCRA certification)?(Preferred NOT required)
