Clinical Research Coordinator I Division of Endocrinology, Diabetes, and Metabolism

Discover Vanderbilt University Medical Center: Located in Nashville Tennessee and operating at a global crossroads of teaching discovery and patient care VUMC is a community ofindividuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued your knowledge expanded and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniquenessis sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilts mission is to advance health and wellness through preeminent programs in patient care education and research.

Organization:

Diabetes/Endocrinology

Job Summary:

The Clinical Research Coordinator I (CTCI) will support clinical research studies within a rare metabolic bone disease program by assisting with study operations data collection regulatory documentation and participant coordination. The CTC1 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 position is designed for an early-career professional who is new to clinical research and seeking a structured environment with mentorship skill development and opportunities for professional growth.

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Primary Responsibilities:

• Supporting study visits and participant coordination

• Assisting with data collection entry and quality control

• Maintaining regulatory documentation and supporting IRB submissions

• Conducting structured chart review and data abstraction; and providing operational and administrative support to the PI and research team.

• The CTRC1 will gain hands-on experience in clinical trial workflow regulatory compliance and research data management within an academic medical center.

• Additional Responsibilities may include 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 phenotypegenotype correlation efforts; and contributing to literature reviews data analysis and manuscript or abstract preparation as appropriate to experience level.

• Candidates with technical or analytical skills may also support database development data visualization website content updates and development of patient-friendly educational materials to enhance research communication and patient engagement.

Preferred Qualifications:

• The ideal candidate is detail-oriented organized motivated to build a career in clinical research or academic medicine and comfortable working in a collaborative clinical environment

• Experience in healthcare research or data management is preferred but not required

KEY RESPONSIBILITIES

• With assistance 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
• Prepares 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. Participates in periodic site visits from sponsor regulatory authorities and others to review research source documentation and research procedures
• Procures equipment and supplies needed to fulfill project requirements
• 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
• 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 performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) 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 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
• Participates in the determination of eligible candidates for study participation assuring participants fulfill eligibility requirements. With guidance 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. Engages in open and positive communication with study participants and coworkers
• With direction performs or instructs others in performing procedures for research as they are described in the protocol deviating from the protocol only when a subjects 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
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

TECHNICAL CAPABILITIES

• 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.
• Communication (Fundamental Awareness): Clearly effectively and respectfully communicates to employees or customers.
• 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.

Our Academic Enterprise is one of the nations longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.

World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.

Aligning with Vanderbilt HealthsStrategic Directions the Office of Research providesshared research resourcesadministrative expertiseand professional guidance to enablethetrans-disciplinary environment and highly collaborative culture that advances discovery and training forall the research faculty trainees students and staff.

Core Accountabilities:

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.

Core Capabilities :

Supporting Colleagues: - 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. Delivering Excellent Services: - 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. Ensuring High Quality: - 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. Managing Resources Effectively :- 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. Fostering Innovation: - 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.

Position Qualifications:

Responsibilities:

Certifications :

Work Experience :

Relevant Work Experience

Experience Level :

Less than 1 year

Education :

Bachelors

Vanderbilt Health is committed tofosteringan environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.