Cardiovascular Translational Research Coordinator II

Vanderbilt University Medical Center; Nashville (TN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health insurance

Job summary

Vanderbilt Health in Nashville seeks a Research Coordinator to coordinate approval processes and conduct of clinical/translational research, ensuring integrity and compliance with policies across studies and sites.

The role emphasizes regulatory oversight, informed consent, data capture, budget management, and collaboration with investigators and sponsors to advance patient-focused research.

Qualifications

• Clinical research experience in a patient-facing research setting, with preference given to candidates whose experience extends beyond laboratory-based research.
• Experience obtaining informed consent and educating patients regarding study participation.
• Familiarity with CITI training and clinical research compliance requirements.
• Experience with patient screening, eligibility assessments, and protocol implementation.
• Knowledge of regulatory processes, IRB requirements, and clinical research documentation.
• Experience collecting, managing, and maintaining accurate clinical research data.
• Proficiency with electronic data capture systems, research databases, and related technology platforms.
• Strong attention to detail with the ability to ensure data quality and regulatory compliance.
• Excellent communication and collaboration skills with the ability to work effectively with patients, families, investigators, and multidisciplinary teams.

Responsibilities

• Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
• Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation. Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation
• Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures
• Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
• With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies
• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible participants
• Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial
• Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

Skills

Clinical research experience

Informed consent

IRB knowledge

Data management

Communication

Education

Bachelor's degree

Tools

Electronic data capture

Research databases

Job description

Vanderbilt Health in Nashville seeks a Research Coordinator to coordinate approval processes and conduct of clinical/translational research, ensuring integrity and compliance with policies across studies and sites.

The role emphasizes regulatory oversight, informed consent, data capture, budget management, and collaboration with investigators and sponsors to advance patient-focused research.