Site Manager​/Lead Clinical Research Coordinator

We are seeking a dynamic and highly organized Site Manager / Lead Clinical Research Coordinator to oversee the planning, execution, and management of clinical trials within our research facilities. This pivotal role involves leading a team of research staff, ensuring compliance with regulatory standards, and maintaining the highest quality of data collection and patient care. The ideal candidate will possess strong leadership skills, extensive clinical research experience, and a passion for advancing healthcare through meticulous project management.

Join us to make a meaningful impact on medical innovation while fostering a collaborative and compliant research environment.

• Lead and supervise the clinical research team, including coordinators, nurses, and support staff, ensuring efficient trial operations.
• Oversee patient recruitment, screening, informed consent processes, and ongoing monitoring to ensure participant safety and protocol adherence.
• Manage all aspects of study documentation review, data collection, and data management in accordance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Ensure compliance with FDA regulations, ICH GCP standards, HIPAA privacy rules, and institutional policies throughout all trial activities.
• Coordinate with sponsors, regulatory bodies, and internal teams to facilitate study initiation, progress monitoring, audits, and closeout procedures.
• Maintain accurate trial records using electronic Medical Record (EMR) systems and other data management tools; review source documents for accuracy and completeness.
• Conduct regular staff training on clinical trial protocols, ethical guidelines, safety procedures including blood sampling and vital signs measurement, as well as documentation standards.

• Proven supervising experience in a clinical research setting or healthcare environment with leadership responsibilities.
• Extensive knowledge of medical terminology, clinical laboratory procedures, blood sampling techniques (phlebotomy), and vital signs assessment.
• Strong understanding of FDA regulations, ICH GCP guidelines, CDISC standards for data collection, and healthcare compliance requirements such as HIPAA.
• Experience with clinical trials management software, EMR systems, statistical software for data analysis, and Microsoft Office suite.
• Certification in Good Clinical Practice
• Demonstrated ability to review complex documentation accurately while maintaining high attention to detail.
• Excellent project management skills with experience in research project coordination from initiation through completion.
• Knowledge of clinical ethical guidelines and quality assurance standards to ensure ongoing compliance across all study activities.
• Background in nursing or healthcare-related fields is advantageous; clinical laboratory experience is highly desirable.

Join us in advancing groundbreaking medical research by leading projects that improve lives! We are committed to fostering an inclusive environment where your expertise can thrive while making a tangible difference in healthcare innovation. All roles are paid positions dedicated to supporting your professional growth within a vibrant research community.

• Austin, TX 78759 (Required)

Work Location:

In person

• Clinical research: 2 years (Required)
• phlebotomy: 2 years (Required)
• Mental health research : 1 year (Required)