Senior Clinical Research Coordinator

The Senior Clinical Research Coordinator will support the Prenatal Cardiology research program in the Heart Center. The individual will be responsible for supporting multiple investigators and managing a large portfolio of studies with little supervision. The Senior Clinical Research Coordinator is responsible for all aspects of study management, including study start-up, IRB submissions and maintenance, developing recruitment and retention plans, working with providers to screen and enroll patients, patient research procedure coordination, and data entry. The individual may also be responsible for basic data analysis or preparation of abstracts and manuscripts. The Senior Clinical Research Coordinator will additionally develop progressive skills in financial management of studies and trials. 

The Senior Clinical Research Coordinator will have strong knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations, as well as previous experience with clinical trials. Experience with or education in cardiology, prenatal, or maternal health research is preferred. Strong scientific writing skills are required. 

This position is 100% on site, with occasional permitted telecommuting based on clinic volume. The earliest start date for this position is July 2, 2025. 

Minimum Education
Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) Or
Master's Degree Master’s degree with at least 2 years of relevant experience (Required)

Minimum Work Experience
3 years At least 3 years of experience with a bachelor's degree. (Required) Or
2 years At least 2 years of experience with a master's degree. (Required)

Required Skills/Knowledge
Knowledge of clinical research designs and needed infrastructure.
Familiarity with databases, data collection tools and data analysis methods.
Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission.
Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment.

Required Licenses and Certifications
Internal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required)
External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire. 1 Year (Required)

Functional Accountabilities
Responsible Conduct of Research

• Consistently demonstrates adherence to the standards for the responsible conduct of research.

• Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.

• Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects’ research and use of protected health information.

• Uses research funds and resources appropriately.

• Maintains confidentiality of data as required.

• Meets all annual job-related training and compliance requirements.

Research Administration

• Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.

• Accurately creates, completes, maintains, organizes and accounts for study materi