Job Description
Job Title: Clinical Research Coordinator
Location: Ozark, Missouri
Type: Direct Hire with Client
Onsite
Job Summary: The Clinical Research Coordinator will oversee the coordination of clinical research studies while providing leadership and guidance to the site’s research team. This role ensures seamless processes, accurate billing of research study visits, and fosters team building to support high-quality clinical trial execution. The CRC is responsible for mentoring staff, managing study operations, and maintaining compliance with regulatory and sponsor requirements.
Key Responsibilities: 1. Leadership and Staff Development - Provide mentorship and training to clinical research coordinators (CRCs) and other site staff.
- Conduct regular performance reviews and set individual development goals for team members.
- Identify training needs and facilitate opportunities for staff to advance their skills, including GCP and protocol-specific education.
- Act as a resource for team members, providing guidance on challenging study-related issues.
2. Study Coordination and Operations - Oversee the day-to-day coordination of assigned clinical research studies, ensuring protocol adherence and regulatory compliance.
- Serve as the primary point of contact for study sponsors, CROs, and auditors.
- Maintain site readiness for audits and monitor visits, ensuring all documentation is current and compliant.
- Develop and maintain standardized processes for screening, enrollment, and study execution to enhance efficiency.
3. Billing and Financial Oversight - Ensure accurate billing of research study visits, procedures, and assessments in accordance with study budgets.
- Track and reconcile study-related payments from sponsors.
- Collaborate with site leadership to resolve financial discrepancies and maintain study profitability.
4. Patient-Centered Coordination - Facilitate the recruitment and enrollment of study participants, ensuring ethical conduct and informed consent.
- Monitor participant safety and address concerns promptly, coordinating with the Principal Investigator as needed.
- Ensure excellent participant experience throughout the study lifecycle to support retention.
5. Team Building and Collaboration - Foster a collaborative and positive team culture, promoting open communication and teamwork.
- Lead regular team meetings to discuss study updates, challenges, and opportunities for improvement.
- Support conflict resolution and encourage a solution-oriented approach among team members.
6. Compliance and Quality Assurance - Ensure adherence to FDA, ICH-GCP, and sponsor requirements for all studies.
- Conduct internal quality checks on documentation, data entry, and regulatory files.
- Develop and implement corrective and preventive action plans (CAPAs) when deviations or errors are identified.
7. Stakeholder Engagement - Act as the liaison between investigators, site staff, and sponsors to facilitate study progress.
- Participate in feasibility reviews and provide feedback on study protocols.
- Represent the site in sponsor and CRO meetings, ensuring alignment with study objectives.
Qualifications: Education and Experience: - Medical Assistant or higher in a related field (life sciences, healthcare, or equivalent).
- Minimum of 2 years of clinical research experience, with prior supervisory or leadership responsibilities preferred.
- Comprehensive knowledge of clinical research protocols, GCP, and regulatory requirements.
Skills and Attributes: - Strong leadership and organizational skills.
- Exceptional attention to detail and ability to manage multiple priorities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.
- Effective communication and interpersonal skills.
- Ability to foster a collaborative and supportive team environment.
Key Performance Indicators (KPIs): - Study Timeliness: Percentage of studies meeting milestones (e.g., enrollment, close-out).
- Billing Accuracy: Rate of error-free billing and timely reconciliation.
- Staff Development: Number of staff achieving certifications or completing training goals.
- Protocol Compliance: Number of protocol deviations per study.
- Patient Enrollment: Percentage of enrollment targets met.
- Sponsor Feedback: Positive sponsor satisfaction ratings on site performance.
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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Ref: #568-Clinical
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