
Job Overview
Employment Type
Full-time
Compensation
Salary
Range $95,000.00 - $115,000.00
Work Schedule
Standard Hours
Benefits
Paid Time Off
Company paid holidays
Employer Paid Medical Insurance
employer paid dental insurance
employer paid vision insurance
Health savings account
Flexible spending account
short-term disability
long-term disability
401(k) retirement plan with company match
Job Description
Care Access is an innovative healthcare organization dedicated to improving the future of health by bridging the gap between advanced clinical research and communities worldwide. With a vast network that includes hundreds of research locations, mobile clinics, and skilled clinicians, Care Access strives to deliver world-class research and health services directly to those who might otherwise face barriers to care. Their mission centers on ensuring that every individual gains a deeper understanding of their health, has access to essential medical care, and can participate in pioneering research that will lay the foundation for tomorrow's medical breakthroughs. By leveraging partnerships, cutting-edge technology, and an unwavering commitment to inclusivity, Care Access continuously reimagines how clinical research and healthcare services are delivered on a global scale.
Care Access undertakes programs such as Future of Medicine, which provides advanced health screenings and research opportunities to underserved communities, and Difference Makers, a program that empowers local leaders to foster community health and wellbeing efforts. These initiatives underscore Care Access's commitment to not only advancing science but also addressing health disparities and promoting equal access to medical innovations.
The role of Region Manager at Care Access is pivotal in ensuring the seamless operation and high performance of multiple clinical research sites within a designated region. This position is responsible for overseeing all aspects of clinical trial execution, ensuring adherence to stringent regulatory standards including Good Clinical Practice (GCP), FDA regulations, International Conference on Harmonisation (ICH) guidelines, and protocol compliance. The Region Manager will lead efforts in site initiation, monitoring, subject recruitment, and study close-out, guaranteeing consistent, timely, and high-quality data collection.
A successful candidate will be an experienced and results-oriented leader who excels in clinical research management and demonstrates strong regulatory knowledge. The role requires a passionate team builder devoted to patient care and operational efficiency. Leadership responsibilities include mentoring and supporting multi-disciplinary site teams, resolving site-level challenges proactively, and fostering a culture of collaboration and high performance.
The position involves financial oversight duties such as managing site budgets, supporting contract negotiations, and optimizing financial performance across sites. Operational strategy development, performance metric monitoring, and regular reporting to senior leadership are integral aspects of the role. The Region Manager also acts as the primary liaison between clinical research sites, sponsors, Contract Research Organizations (CROs), and internal departments, promoting transparency and advocating for site needs.
Risk mitigation and problem-solving skills are essential, as the role involves identifying potential operational challenges and implementing effective solutions. The ability to flexibly perform Clinical Research Coordinator duties when needed underscores the hands-on leadership approach necessary. The position offers remote work within the United States, with an expectation of up to 50% travel to clinical sites, and provides a competitive salary range between $95,000 and $115,000 USD annually for full-time employees.
Care Access offers a comprehensive benefits package for full-time US employees, including paid time off and company-paid holidays, fully employer-paid medical, dental, and vision insurance options, health savings and flexible spending accounts with employer contributions, company-paid short-term and long-term disability plans, and a 401(k) retirement savings plan with company match. As an employer, Care Access is firmly committed to diversity, equity, and inclusion, ensuring equal opportunity and a respectful workplace for individuals from diverse backgrounds and communities. This commitment is integral to the organization’s identity and success in achieving its mission to make health better for all.
Care Access undertakes programs such as Future of Medicine, which provides advanced health screenings and research opportunities to underserved communities, and Difference Makers, a program that empowers local leaders to foster community health and wellbeing efforts. These initiatives underscore Care Access's commitment to not only advancing science but also addressing health disparities and promoting equal access to medical innovations.
The role of Region Manager at Care Access is pivotal in ensuring the seamless operation and high performance of multiple clinical research sites within a designated region. This position is responsible for overseeing all aspects of clinical trial execution, ensuring adherence to stringent regulatory standards including Good Clinical Practice (GCP), FDA regulations, International Conference on Harmonisation (ICH) guidelines, and protocol compliance. The Region Manager will lead efforts in site initiation, monitoring, subject recruitment, and study close-out, guaranteeing consistent, timely, and high-quality data collection.
A successful candidate will be an experienced and results-oriented leader who excels in clinical research management and demonstrates strong regulatory knowledge. The role requires a passionate team builder devoted to patient care and operational efficiency. Leadership responsibilities include mentoring and supporting multi-disciplinary site teams, resolving site-level challenges proactively, and fostering a culture of collaboration and high performance.
The position involves financial oversight duties such as managing site budgets, supporting contract negotiations, and optimizing financial performance across sites. Operational strategy development, performance metric monitoring, and regular reporting to senior leadership are integral aspects of the role. The Region Manager also acts as the primary liaison between clinical research sites, sponsors, Contract Research Organizations (CROs), and internal departments, promoting transparency and advocating for site needs.
Risk mitigation and problem-solving skills are essential, as the role involves identifying potential operational challenges and implementing effective solutions. The ability to flexibly perform Clinical Research Coordinator duties when needed underscores the hands-on leadership approach necessary. The position offers remote work within the United States, with an expectation of up to 50% travel to clinical sites, and provides a competitive salary range between $95,000 and $115,000 USD annually for full-time employees.
Care Access offers a comprehensive benefits package for full-time US employees, including paid time off and company-paid holidays, fully employer-paid medical, dental, and vision insurance options, health savings and flexible spending accounts with employer contributions, company-paid short-term and long-term disability plans, and a 401(k) retirement savings plan with company match. As an employer, Care Access is firmly committed to diversity, equity, and inclusion, ensuring equal opportunity and a respectful workplace for individuals from diverse backgrounds and communities. This commitment is integral to the organization’s identity and success in achieving its mission to make health better for all.
Job Requirements
- Bachelor's degree preferred or equivalent combination of education, training and experience
- minimum 5 years of clinical research experience with 1 or more years in a leadership role
- multi-site management experience preferred
- demonstrated expertise in overseeing multiple clinical research trials across varying therapeutic areas
- strong understanding of good clinical practice, FDA regulations, ICH guidelines, and industry best practices
- excellent verbal and written communication skills
- highly organized with strong attention to detail and compliance
- proficiency in clinical trial management systems and Microsoft Office Suite
- ability to manage multiple priorities and meet deadlines in a fast-paced environment
- ability to adapt to frequent changes in responsibilities and workloads
- willingness to travel up to 50 percent
- ability to perform clinical research coordinator duties as needed
Job Qualifications
- Bachelor's degree preferred or equivalent combination of education, training, and experience
- minimum 5 years of clinical research experience with at least 1 year in a leadership role
- multi-site management experience preferred
- demonstrated expertise in overseeing multiple clinical research trials across various therapeutic areas
- strong understanding of GCP, FDA regulations, ICH guidelines, and industry best practices
- exceptional leadership and team-building capabilities
- excellent verbal and written communication skills
- highly organized with strong attention to detail and compliance
- proficient in Clinical Trial Management Systems (CTMS) and Microsoft Office Suite
- ability to manage multiple priorities and meet deadlines in a fast-paced environment
- ability to adapt to frequent changes in responsibilities and workloads
- curiosity, passion to learn, innovate, and take thoughtful risks
- friendly and outgoing personality with the ability to maintain a positive attitude under pressure
- proven ability to maintain site profitability
Job Duties
- Oversee day-to-day operations at multiple clinical research sites within the region
- ensure trials are conducted in full compliance with Good Clinical Practice (GCP), FDA, ICH, and protocol requirements
- lead all phases of clinical trial execution including site initiation, monitoring, subject recruitment, and study close-out
- ensure consistent, high-quality data collection and timely patient enrollment across all sites
- lead, mentor, and support site-level teams including Principal Investigators, Clinical Research Coordinators, and other staff
- promote a collaborative and high-performance work culture through coaching, development, and team-building
- proactively resolve site-level challenges and performance issues
- ensure strict adherence to study protocols, IRB/ethics board guidelines, and applicable federal regulations
- conduct internal site audits and oversee corrective actions
- maintain accurate and timely documentation including ICFs, AEs, SAEs, and source documents
- manage site budgets and ensure adherence to financial agreements
- support contract negotiations and oversee invoicing and payment processes
- monitor and optimize financial performance at each site
- collaborate with sponsors, CROs, and internal departments to ensure seamless clinical trial execution
- monitor site performance metrics and provide regular reports to leadership
- oversee proper management of site resources, investigational product inventory, and study supplies
- build and maintain strong relationships with Principal Investigators and key site personnel
- serve as the main liaison between clinical research sites, sponsors, and internal leadership
- advocate for site needs and promote transparency in communication
- identify and proactively address potential risks or operational issues
- work collaboratively with internal teams to implement effective solutions and improve site efficiency
- perform Clinical Research Coordinator duties at sites as needed
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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