Clinical Research Coordinator I

Located in Nashville, Tennessee, Vanderbilt University Medical Center (VUMC) operates at a global crossroads of teaching, discovery, and patient care. It is a community where expertise is valued, knowledge is expanded, and abilities are challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and uniqueness is celebrated.

About the role

Responsible for coordinating the approval processes and conduct of research protocols to maintain the integrity and quality of clinical/translational research. This role ensures research is conducted in accordance with all policies and federal regulations, with some guidance.

Responsibilities

• With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional, departmental, and federal policies.
• Prepares and maintains documents required for regulatory authorities and/or sponsors before, during, and after clinical/translational trials.
• Participates in periodic site visits from sponsors, regulatory authorities, and others to review research, source documentation, and research procedures.
• Procures equipment and supplies needed for project requirements.
• Records data from source documentation or participant interaction onto case report forms (paper or electronic), ensuring accuracy, completeness, and timeliness. Resolves queries promptly.
• Ensures research information is collected and stored compliantly with regulations, policies, and good clinical practice.
• Performs packaging and shipping of study specimens (e.g., blood, urine) to sponsors or laboratories in accordance with guidelines, maintaining proper documentation.
• With direction, assists with study completion, closeout, and archiving of study files, ensuring completeness and continuity of all study data.
• With supervision, develops and manages study budgets, monitors efficient invoicing, and maintains clinical trial billing compliance.
• Serves as an advocate for human subjects by maintaining communication with investigators, research staff, sponsors, participants, and regulatory representatives.
• Participates in determining eligible candidates for study participation, ensuring participants fulfill eligibility requirements.
• With guidance, assesses and evaluates participants’ medical and historical information to ensure appropriate enrollment and continued eligibility.
• Performs or instructs others in research procedures as described in the protocol, reporting deviations promptly to the Principal Investigator or senior personnel.
• Engages in open and positive communication with study participants and coworkers.

Qualifications

• Education: Bachelor’s degree.
• Relevant Work Experience: Less than 1 year.
• Technical Capabilities:
  • Project Coordination: Fundamental awareness; has worked on at least one project in a support role.
  • Study Design & Conduct: Applies qualitative and quantitative research methods for preparatory, regulatory, and analytic tasks.
  • Communication: Clearly, effectively, and respectfully communicates with employees or customers.
  • Clinical Research: Knowledge of primary resources; can research simple clinical questions and archive study documentation.

Benefits

This role offers a comprehensive benefits package, which may include health, disability, retirement, and/or wellness offerings to enhance well-being and professional growth.