Urology San Antonio
Clinical Research Supervisor
The Clinical Research Supervisor provides day-to-day operational leadership across clinical research activities, with a focus on workflow coordination, staff oversight, quality control, and ensuring study-related activities are conducted accurately and efficiently. The role also includes direct supervision of Clinical Research Coordinators and cross-functional leadership to support recruitment, screening, data integrity, and sponsor/CRO operations.
Key Responsibilities
- • Oversee daily research operations, including visit scheduling, workflow coordination, and task prioritization.
- • Ensure all staff adhere to study protocols, SOPs, GCP guidelines, and regulatory requirements.
- • Troubleshoot operational issues and escalate complex challenges to the Clinical Research Manager as needed.
- • Monitor timelines for study visits, data entry, query resolution, and documentation completion.
- • Provide direct supervision to Clinical Research Coordinators.
- • Provide day-to-day direction, workflow coordination, and functional oversight for Study Coordinators, Recruiters/Screeners, Data Coordinators, and Lab Support Staff, in partnership with their respective supervisors.
- • Manage daily staffing needs by balancing workloads and reallocating resources as necessary.
- • Deliver real-time coaching, mentoring, and competency-based feedback to support staff performance.
- • Lead onboarding and hands-on training for new hires.
- • Support performance evaluations by contributing observations, metrics, and feedback to appropriate supervisors and the Clinical Research Manager.
- • Execute recruitment strategies, monitor performance metrics, and identify barriers to enrollment.
- • Ensure consistent and accurate screening procedures across all studies.
- • Optimize screening workflows to improve efficiency and participant engagement.
- • Conduct routine chart reviews, source-to-CRF reconciliation, and protocol compliance checks.
- • Identify operational gaps and implement corrective actions in collaboration with leadership.
- • Ensure protocol deviations, AEs/SAEs, and other reportable events are properly documented and escalated.
- • Serve as the operational lead during monitoring visits (SQVs, SIVs, IMVs, and close-out visits).
- • Ensure staff, documentation, and study materials are prepared and audit-ready.
- • Track and ensure timely completion of follow-up items and monitor requests.
- • Provide hands-on support with patient visits, data review, specimen processing, or study procedures during high-volume or low-staff periods.
- • Promote a culture of quality, accountability, and teamwork across all research functions.
Required
- • Bachelor’s degree in Life Science, Healthcare, or related field required.
- • Minimum of 3 years of clinical research experience, including 1–2 years in a leadership, training, or lead role.
- • Strong knowledge of clinical site operations, documentation standards, and recruitment workflows.
- • Working knowledge of GCP, FDA regulations, ICH guidelines, and IRB requirements.
- • Excellent communication, problem-solving, and organizational skills.
- • Proven ability to lead and coordinate teams in a fast-paced, deadline-driven environment.
Preferred
- • Nursing or Medical Degree
- • HIPAA compliance
- • Bilingual/Spanish
- • Clinical Research Certification
Job Summary
The Clinical Research Supervisor is responsible for providing day-to-day operational leadership across clinical research activities. This role focuses on workflow coordination, functional staff oversight, quality control, and ensuring that study-related activities are conducted accurately, efficiently, and in accordance with protocol and regulatory requirements.
The Supervisor serves as the first-line operational lead for clinical research staff—driving execution, resolving day-to-day challenges, monitoring performance, and ensuring the successful delivery of clinical trials. This role includes direct supervision of Clinical Research Coordinators and provides cross-functional leadership to other research support roles.
Key Responsibilities
Operational Leadership
This job description does not cover or contain a comprehensive listing of activities, duties, or responsibilities required for this job. In addition, duties, responsibilities, and activities may change at any time with or without notice.
COMPETENCIES
Required
The Clinical Research Supervisor is responsible for providing day-to-day operational leadership across clinical research activities. This role focuses on workflow coordination, functional staff oversight, quality control, and ensuring that study-related activities are conducted accurately, efficiently, and in accordance with protocol and regulatory requirements.
The Supervisor serves as the first-line operational lead for clinical research staff—driving execution, resolving day-to-day challenges, monitoring performance, and ensuring the successful delivery of clinical trials. This role includes direct supervision of Clinical Research Coordinators and provides cross-functional leadership to other research support roles.
Key Responsibilities
Operational Leadership
- Oversee daily research operations, including visit scheduling, workflow coordination, and task prioritization.
- Ensure all staff adhere to study protocols, SOPs, GCP guidelines, and regulatory requirements.
- Troubleshoot operational issues and escalate complex challenges to the Clinical Research Manager as needed.
- Monitor timelines for study visits, data entry, query resolution, and documentation completion.
- Provide direct supervision to Clinical Research Coordinators.
- Provide day-to-day direction, workflow coordination, and functional oversight for Study Coordinators, Recruiters/Screeners, Data Coordinators, and Lab Support Staff, in partnership with their respective supervisors.
- Manage daily staffing needs by balancing workloads and reallocating resources as necessary.
- Deliver real-time coaching, mentoring, and competency-based feedback to support staff performance.
- Lead onboarding and hands-on training for new hires.
- Support performance evaluations by contributing observations, metrics, and feedback to appropriate supervisors and the Clinical Research Manager.
- Execute recruitment strategies, monitor performance metrics, and identify barriers to enrollment.
- Ensure consistent and accurate screening procedures across all studies.
- Optimize screening workflows to improve efficiency and participant engagement.
- Conduct routine chart reviews, source-to-CRF reconciliation, and protocol compliance checks.
- Identify operational gaps and implement corrective actions in collaboration with leadership.
- Ensure protocol deviations, AEs/SAEs, and other reportable events are properly documented and escalated.
- Serve as the operational lead during monitoring visits (SQVs, SIVs, IMVs, and close-out visits).
- Ensure staff, documentation, and study materials are prepared and audit-ready.
- Track and ensure timely completion of follow-up items and monitor requests.
- Provide hands-on support with patient visits, data review, specimen processing, or study procedures during high-volume or low-staff periods.
- Promote a culture of quality, accountability, and teamwork across all research functions.
This job description does not cover or contain a comprehensive listing of activities, duties, or responsibilities required for this job. In addition, duties, responsibilities, and activities may change at any time with or without notice.
COMPETENCIES
- Patient & Customer Focus
- Ethical Conduct
- Flexibility
- Initiative
- Personal Effectiveness/Credibility
- Stress Management/Composure
- Stress Management/Composure High attention to detail and strong organizational skills
- Excellent written and verbal communication skills
- Ability to work well independently
- Maintain confidentiality
- Experience with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)
- Possess strong skills for multitasking, meeting competing deadlines, prioritizing, and supporting PIs for multiple projects
Required
- Bachelor’s degree in Life Science, Healthcare, or related field required.
- Minimum of 3 years of clinical research experience, including 1–2 years in a leadership, training, or lead role.
- Strong knowledge of clinical site operations, documentation standards, and recruitment workflows.
- Working knowledge of GCP, FDA regulations, ICH guidelines, and IRB requirements.
- Excellent communication, problem-solving, and organizational skills.
- Proven ability to lead and coordinate teams in a fast-paced, deadline-driven environment.
- Nursing or Medical Degree
- HIPAA compliance
- Bilingual/Spanish
- Clinical Research Certification
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