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Organization:

Pediatric Endocrinology

Job Summary:

JOB SUMMARY

The Pediatric Endocrinology Research Program at Vanderbilt University Medical Center is seeking a Certified Clinical Research Professional (CCRP) to coordinate day-to-day clinical research activities focused on Type 1 Diabetes (T1DM) related cardiometabolic outcomes in pediatric and adult populations. This position will support multiple NIH-funded (R01) and industry-sponsored studies aiming to improve therapeutic strategies for patients living with T1DM.

While this role involves substantial patient-facing responsibilities (e.g., obtaining informed consent, scheduling, and coordinating study visits), the CCRP will also function as a key liaison for regulatory, data, and sponsor-related tasks under the guidance and supervision of the Principal Investigator.

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KEY RESPONSIBILITIES

Study Coordination & Participant Engagement

• Serve as the primary point-of-contact for participant recruitment efforts in T1DM metabolism studies.

• Lead informed consent processes and coordinate scheduling/logistics for study visits, ensuring a positive participant and family experience.

Regulatory Compliance & IRB Submissions

• Act as a liaison to the IRB, preparing and submitting new protocols, amendments, continuing reviews, and adverse event reports.

• Maintain compliance with all Good Clinical Practice (GCP) guidelines, federal regulations, and Vanderbilt policies regarding the conduct of clinical research.

• Oversee and organize essential documents, regulatory binders, and study master files per sponsor and institutional requirements.

Data & Sponsor Management

• Coordinate and maintain accurate study documentation in REDCap or other approved data management systems for screening, enrollment, and study visit data.

• Assist in responding to sponsor or FDA queries regarding regulatory filings (e.g., IND submissions), data clarifications, and progress updates.

• Collaborate with the PI and statisticians to facilitate database management and ensure data integrity for interim analyses and final study reports.

Study Logistics & Collaboration

• Assist in the logistical planning of medication deliveries and scheduling participants at the Clinical Research Center (CRC) for research visits.

• Communicate effectively with the multidisciplinary team--including RNs, MDs, dietitians, biostatisticians, and lab personnel--ensuring smooth implementation of protocol procedures.

Research Development & Professional Growth

• Participate in aspects of study design and analysis under the supervision and guidance of the principal investigator.

• Contribute to team discussions about patient recruitment, retention strategies, and protocol optimization.

• Maintain active CCRP certification and remain current on new regulations or best practices in clinical research.

Additional Information

• Population/Setting: Pediatric and adults patients with T1DM, glucokinase-maturity onset diabetes of the young (GCK-MODY), and control participants without diabetes, potentially including family/guardian engagement to support informed consent and study compliance.

• Funding & Focus: Primarily funded by two R01 grants centered on metabolically enhancing autoimmune immunotherapy, adjunctive anti-diabetic medications, and cardiometabolic outcomes in T1DM.

• Supervision & Mentorship: This position reports to the Principal Investigator and operates within a collaborative team of research faculty and staff. Opportunities for professional development (e.g., co-authoring manuscripts, presenting data) may be available but are not a principal focus of this role.

Qualifications & Competencies

• Education & Certification:

  • Active CCRP (Certified Clinical Research Professional) certification (e.g., through SoCRA) or equivalent.

• Clinical Research Experience:

  • Demonstrated experience coordinating patient-facing clinical research protocols, ideally in an academic medical center setting.

  • Familiarity with IRB processes, FDA/IND regulations, and the full lifecycle of clinical trials (from start-up to close-out).

• Technical & Administrative Skills:

  • Proficiency in data collection platforms (REDCap, OnCore) and basic office software (Word, Excel, Outlook).

  • Ability to coordinate and track multiple regulatory submissions, ensuring timelines are met and documentation is complete.

  • Ability to prepare and process plasma samples for assay of hormonal and metabolic assays.

• Interpersonal Skills:

  • Strong communication skills to engage with participants, guardians, and a multidisciplinary research team.

  • Excellent organizational abilities to manage multiple tasks, regulatory documents, and sponsor queries concurrently.

Our Academic Enterprise is one of the nation's 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 Health's Strategic Directions, the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.

Core Accountabilities:

Organizational Impact: Delivers projects/assignments that have a direct impact on goals/objectives of the unit/department that the job is in. Problem Solving/ Complexity of work: Conducts extensive analysis of situations or data to resolve numerous, complex issues; may involve the input/work of others. Breadth of Knowledge: Has in-depth level of knowledge within a professional area and working knowledge of other areas. Team Interaction: May lead mid-sized projects; coaches and guides team members.

Core Capabilities :

Supporting Colleagues: - Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas. - Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships. - Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Service: - Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions. - Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly. - Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area. - Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation: - Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches. - Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges. - Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.

Position Qualifications:

Responsibilities:

Certifications :

Certified Clinical Research Coordinator - Certification - Others, Certified Clinical Research Professional - Society of Clinical Research Associates, LIC-Licensed Discipline Specific - Licensure-Others

Work Experience :

Relevant Work Experience

Experience Level :

5 years

Education :

Bachelor's

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