"Clinical Research Coordinator B/C"

With minimal supervision, the clinical research coordinator will coordinate Phase I-IV clinical trials, registries, and other NIH-funded research studies for the Pulmonary Vascular Disease Program. Screen, recruit, consent and enroll eligible subjects per protocol using GCP guidelines. Implement various research protocols and guidelines. Provide education to the patient and/or families. Responsible for management and oversight of research medication administration, monitoring of patient care, monitoring of side effects/adverse events, and maintaining general oversight of patient status throughout study period. Will record and report adverse events and serious adverse events per protocols. Manage patient treatment per protocol, schedule clinical and research office visits, interact with cardiology and pulmonary staff to schedule and oversee research testing. Responsible for drawing labs (phlebotomy training preferred), sample processing and shipping. Responsible for performing vital signs and EKGs for study visits. Organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. Responsible for accurate data collection and data entry. Work closely with study sponsors and physicians. Communicate any research issues to PI and primary MD, communication with research team, including Investigators, project managers, CRC and regulatory team, to ensure patient safety and proper study conduct. Participate in initiation, monitoring, audit and closeout visits. Participate in study team meetings and ongoing protocol training/compliance meetings. Demonstrate vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.

Clinical Research Coordinator B
With minimal supervision, the Clinical Research Coordinator at Level B will coordinate Phase I-IV clinical trials, registries, and NIH-funded studies within the Pulmonary Vascular Disease Program. Responsibilities include screening, recruiting, consenting, and enrolling eligible subjects according to protocol and Good Clinical Practice (GCP) guidelines. The coordinator will implement research protocols, provide education to patients and/or families, and schedule research office visits. They will interact with research staff to coordinate research testing, perform vital signs and EKGs, and handle phlebotomy, lab processing, and shipping (phlebotomy training preferred). Additional tasks include organizing and maintaining essential documentation such as source documentation, case report forms, and research charts. The coordinator will be responsible for accurate data collection and entry, participate in study team meetings, and follow all University of Pennsylvania, FDA, and GCP guidelines. Participation in study initiation, monitoring, audit, and closeout visits is also required, as is clear communication with the research team to ensure protocol adherence and patient safety.

Clinical Research Coordinator C
At Level C, the Clinical Research Coordinator will independently manage the full scope of complex clinical research activities for the Pulmonary Vascular Disease Program, including clinical trials and multiple concurrent NIH-funded studies. This role assumes responsibility for the oversight of research medication administration, monitoring of patient care, evaluating and escalating side effects or adverse events, and maintaining continuous oversight of patient safety throughout the study duration. The coordinator will manage patient treatment regimens per protocol and ensure adherence through coordination with multidisciplinary teams. They will lead the reporting of adverse events and serious adverse events and may contribute to the development of corrective action plans when necessary. This level requires proactive communication with sponsors, investigators, and cross-functional research teams (including regulatory and data management teams), ensuring protocol compliance and operational efficiency. The Level C coordinator will lead aspects of regulatory and monitoring visits, participate in strategic discussions, mentor junior staff, and identify process improvements to enhance study quality and patient safety. A high degree of autonomy, leadership, and expertise in GCP and institutional policies is expected.

QUALIFICATIONS:

Clinical Research Coordinator B

• Bachelor's degree and 2-3 years of related clinical research experience, or an equivalent combination of education and experience
• Phlebotomy experience preferred
• Strong communication, writing, organizational, and time management skills
• Ability to work both independently and as part of a team
• Flexible, detail-oriented, and able to multitask effectively
• Familiarity with IRB processes and human subject research regulations
• Position contingent upon funding

Clinical Research Coordinator C

• Bachelor's degree and a minimum of 4 years of progressively responsible clinical research experience, or equivalent combination of education and experience
• Phlebotomy experience preferred
• Demonstrated ability to independently manage complex clinical trials
• Strong leadership, communication, and organizational skills
• Proven experience working with multidisciplinary teams and sponsors
• In-depth knowledge of IRB regulations, FDA guidelines, and GCP standards
• Experience mentoring junior staff and overseeing multiple studies
• Position contingent upon funding

Position contingent upon funding.