Clinical Research Coordinator - PRN

Vanderbilt University Medical Center • Nashville, TN

1d

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
• Project Coordination
• Study Design & Conduct
• Clinical Research
• Organizational Impact: Delivers job responsibilities that impact own job area/team with some guidance.
• Problem Solving/ Complexity of work: Uses existing procedures, research and analysis to solve standard job related problems that may require some judgement.
• Breadth of Knowledge: Requires subject matter knowledge within a professional area to meet job requirements.
• Team Interaction: Individually contributes to project/ work teams.
• Develops Self and Others: Continuously improves own skills by identifying development opportunities.
• Builds and Maintains Relationships: Seeks to understand colleagues priorities, working styles and develops relationships across areas.
• Communicates Effectively: Openly shares information with others and communicates in a clear and courteous manner.
• Serves Others with Compassion: Invests time to understand the problems, needs of others and how to provide excellent service.
• Solves Complex Problems: Seeks to understand issues, solves routine problems, and raises proper concerns to supervisors in a timely manner.
• Offers Meaningful Advice and Support: Listens carefully to understand the issues and provides accurate information and support.
• Performs Excellent Work: Checks work quality before delivery and asks relevant questions to meet quality standards.
• Ensures Continuous Improvement: Shows eagerness to learn new knowledge, technologies, tools or systems and displays willingness to go above and beyond.
• Fulfills Safety and Regulatory Requirements: Demonstrates basic knowledge of conditions that affect safety and reports unsafe conditions to the appropriate person or department.
• Demonstrates Accountability: Takes responsibility for completing assigned activities and thinks beyond standard approaches to provide high-quality work/service.
• Stewards Organizational Resources: Displays understanding of how personal actions will impact departmental resources.
• Makes Data Driven Decisions: Uses accurate information and good decision making to consistently achieve results on time and without error.
• Generates New Ideas: Willingly proposes/accepts ideas or initiatives that will impact day-to-day operations by offering suggestions to enhance them.
• Applies Technology: Absorbs new technology quickly; understands when to utilize the appropriate tools and procedures to ensure proper course of action.
• Adapts to Change: Embraces changes by keeping an open mind to changing plans and incorporates change instructions into own area of work.
• Relevant Work Experience Experience Level : Less than 1 year
• 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, and 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 maintaining 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 managing 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 evaluating 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
• Number of Employees: 5,001-10,000 employees