What are the responsibilities and job description for the Clinical Research Manager position at Modena Allergy Asthma?
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 standards 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.
Position Summary
We are seeking an experienced Clinical Research Site Manager to lead operations across multiple clinical research sites, with primary responsibility for our La Jolla, CA location. This role provides leadership to Clinical Research Coordinators at more than one site and ensures consistent, high-quality, compliant execution of clinical studies. The Site Manager will oversee staff development, operational efficiency, regulatory compliance, and data quality, while ensuring data integrity and high standards of research conduct across all assigned sites.
This position requires travel, with occasional support at our Los Angeles clinic sites in Torrance, Long Beach, Scottsdale AZ. This role is non-exempt (hourly) and full-time, working standard business hours with flexibility for early or late visits as needed for study conduct. 40 hours per week, Monday through Friday, onsite in our La Jolla Clinic.
Key Responsibilities
Multi-Site Leadership & Operational Oversight:
The hourly range for this position is $40.00-$50.00/hour. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate's skills, education, and experience.
Physical Requirements
Ability to stand, walk, and move throughout the clinic, if applicable, for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment, if applicable.
What We Offer
California Consumer Privacy Act (CCPA) Notice
Orso Health ("OH") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.
Position Summary
We are seeking an experienced Clinical Research Site Manager to lead operations across multiple clinical research sites, with primary responsibility for our La Jolla, CA location. This role provides leadership to Clinical Research Coordinators at more than one site and ensures consistent, high-quality, compliant execution of clinical studies. The Site Manager will oversee staff development, operational efficiency, regulatory compliance, and data quality, while ensuring data integrity and high standards of research conduct across all assigned sites.
This position requires travel, with occasional support at our Los Angeles clinic sites in Torrance, Long Beach, Scottsdale AZ. This role is non-exempt (hourly) and full-time, working standard business hours with flexibility for early or late visits as needed for study conduct. 40 hours per week, Monday through Friday, onsite in our La Jolla Clinic.
Key Responsibilities
Multi-Site Leadership & Operational Oversight:
- Provide operational leadership and management across multiple clinical research sites, ensuring consistency in workflow, quality, and compliance.
- Hire, onboard, train, and evaluate Clinical Research Coordinators and support staff across sites.
- Monitor staffing levels and coordinate resource allocation across all active trials and locations.
- Oversee day-to-day clinical operations, visit scheduling, and subject care across sites.
- Ensure research staff at all locations follow protocols, SOPs, GCP, and institutional policies.
- Maintain and document training standards across all assigned sites.
- Contribute to patient recruitment and retention strategies across the site network.
- Foster a culture of teamwork, accountability and "Quality Without Compromise"
- Supervise the implementation and adherence to study protocols across multiple sites.
- Ensure timely and accurate source documentation and data entry at each location.
- Ensure all sites meet electronic regulatory requirements and maintain audit-ready regulatory documentation.
- Support internal and external audits across all assigned research sites.
- Monitor data quality across locations to ensure accuracy, completeness, consistency, and data integrity.
- Conduct remote or onsite monitoring visits at various sites to review source documents, CRFs, and regulatory materials.
- Maintain data integrity and research conduct through ongoing oversight and timely resolution of data discrepancies.
- Coordinate and support external monitoring visits across locations, including preparation, communication, and follow-up.
- Document monitoring activities in compliance with SOPs, GCP, and ICH guidelines.
- Implement and support quality assurance initiatives that enhance operational consistency and research conduct across all sites.
- Assist in audit preparation and regulatory inspections across multiple sites.
- Maintain compliant regulatory files and electronic systems for each assigned location.
- Identify operational or documentation gaps across sites and support corrective and preventive action plans.
- Perform additional responsibilities as needed to support multi-site clinical operations.
- Education: Bachelor's degree in life sciences, healthcare, or related field.
- Experience:
- Minimum of 5 years of experience in clinical research, preferably involving multi-site management, monitoring, or data oversight.
- Prior supervisory or team leadership experience strongly preferred.
- Strong working knowledge of FDA regulations, ICH-GCP, and clinical trial operations
- Skills & Abilities:
- Strong understanding of GCP, ICH guidelines, and end-to-end clinical trial operations across multiple sites.
- Excellent attention to detail and organizational skills, particularly in multi-site environments.
- Strong communication skills to effectively support and coordinate cross-site teams.
- Proficiency with CTMS, EDC platforms, electronic regulatory systems, and Microsoft Office Suite.
- Analytical mindset with strong problem-solving capabilities.
- Ability to manage priorities effectively across multiple locations.
- Commitment to quality, data integrity, ethical research conduct, and regulatory compliance.
- Core Values and Culture: The Clinical Research Manager is expected to embody our organization's commitment to integrity, quality, collaboration, and continuous improvement. We value leaders who promote teamwork, foster innovation, and ensure excellence in research execution.
The hourly range for this position is $40.00-$50.00/hour. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate's skills, education, and experience.
Physical Requirements
Ability to stand, walk, and move throughout the clinic, if applicable, for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment, if applicable.
What We Offer
- Competitive salary and benefits package, including medical, dental & vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities
- In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay
- Opportunity to shape the future of cutting-edge clinical research in beautiful San Diego (and across our expanding network)
- An opportunity to play an active role in medical advancement
California Consumer Privacy Act (CCPA) Notice
Orso Health ("OH") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.
Salary : $40 - $50
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