Clinical Translational Research Coordinator I - Onsite, Nashville TN

About the role

This role supports an early cancer-diagnosis study as a key member of the research team, coordinating clinical and regulatory activities. Substantial computer-based work includes patient tracking, reviewing survey results, and maintaining accurate study records. When trial requirements allow, the coordinator will consent eligible patients and monitor patient timelines to ensure appropriate follow-up appointments and additional diagnostic checkups. The position requires empathy, clear communication, and strong interpersonal skills, as the study population may be navigating emotionally challenging circumstances. Regulatory responsibilities include ensuring compliance with study protocols, data privacy standards, and institutional requirements.

Responsibilities

• With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional, departmental, and federal regulations.
• Prepares and maintains documents required internally and for regulatory authorities and/or the sponsor before, during, and after a clinical/translational trial.
• Participates in periodic site visits from sponsors, regulatory authorities, and others to review research, source documentation, and procedures.
• Procures equipment and supplies needed to fulfill project requirements.
• Records data from source documentation and/or participant interaction onto case report forms (paper or electronic) with attention to accuracy, completeness, and timeliness; attends to query resolution promptly.
• Ensures research information is collected and stored in a compliant manner consistent with regulations, policies, and good clinical practice.
• 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, assists with study completion, study closeout, and archiving of study files, ensuring completeness and continuity of all study data; performs ongoing checks of clinical/translational data entered on case report forms or in reports.
• With supervision, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance.
• Serves as an advocate for human subjects by maintaining communication with investigators, research staff, sponsors, participants, and relevant stakeholders; monitors trial processes and participant protections.
• Participates in determining eligible candidates for study participation, ensuring participants meet eligibility requirements.
• With guidance, assesses and evaluates potential participants’ pertinent medical and historical information to ensure appropriate enrollment and continued eligibility.
• Engages in open and positive communication with study participants and coworkers.
• With direction, performs or instructs others in performing procedures as described in the protocol; deviates from the protocol only when a subject’s safety is at risk and reports all deviations to the Principal Investigator and/or senior personnel for appropriate action.

Preferred Skills & Experience

• Strong interpersonal awareness and the ability to read and adapt to different audiences and situations.
• Experience using Epic electronic health record (EHR) systems.
• Experience with OnCore clinical trial management software.
• Experience using REDCap for research data collection and management.
• Experience with data analysis, reporting, and dashboard development.
• HIPAA training and a demonstrated understanding of patient privacy and data security requirements.