Clinical Research Coordinator - PRN

Vanderbilt University Medical Center • Nashville, TN

9d

About The Position

The PRN Clinical Research Coordinator will support clinical research studies within a rare metabolic bone disease program by assisting with study operations, data collection, regulatory documentation, and participant coordination. They will work closely with the Principal Investigator (PI), investigators, study coordinators, and clinical staff to ensure research activities are conducted in accordance with study protocols, institutional policies, and regulatory requirements. This role is well-suited for a recent college graduate seeking a structured gap year prior to medical or graduate school with immersive exposure to clinical medicine and translational research .

Requirements

• Communication (Novice): Clearly, effectively and respectfully communicates to employees or customers.
• Project Coordination (Fundamental Awareness): Has light experience, training, direct exposure, or past experience with Project Coordination. Has worked on at least one project in a support role. Collects and collates project related material such as project initiation documents, project status reports, project metrics, and project completion data.
• Study Design & Conduct (Fundamental Awareness): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
• Clinical Research (Fundamental Awareness): Knows the primary resources available to accomplish the job. Can successfully research simple clinical questions pertaining to the functional area. Files and collates trial documentation and reports. Archives study documentation and correspondence. Demonstrates a systematic approach to problem solving.
• Bachelor's

Nice To Haves

• Recent college graduate pursuing medicine or biomedical research with strong organizational and communication skills
• Interest in rare disease or genomics
• Comfort interacting with patients
• Experience with data analysis, coding, or database management is preferred

Responsibilities

• Supporting study visits, participant coordination, data entry, regulatory documentation and IRB submissions
• Structured chart review and data abstraction
• Database management and quality control
• Providing operational support to the PI and research team
• Assisting with standardized functional assessments during clinic visits
• Engaging with patients and families in a longitudinal rare disease clinic
• Constructing multigenerational family pedigrees and supporting phenotype–genotype correlation efforts
• Contributing to literature reviews, manuscript preparation, and abstract submissions
• Participating in research meetings and protocol development
• Preparing and processing new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
• Preparing and maintains documents required to be maintained and available internally and for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial.
• Participating in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
• Procuring equipment and supplies needed to fulfill project requirements
• Recording 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.
• Attending to query resolution in a timely manner.
• Assuring research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice
• Performing 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
• Assisting with study completion, study closeout and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports
• Developing and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance
• Serving 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 for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants
• Participating in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements.
• Assessing 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.
• Engaging in open and positive communication with study participants and coworkers
• Performing or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and in a timely manner reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other safety reporting to appropriate funding/regulatory agencies is required

What This Job Offers

• Job Type: Part-time
• Career Level: Entry Level