Cardiovascular Clinical Translational Research Coordinator II - Hybrid in Nashville TN

Discover Vanderbilt Health : With eight hospitals and over 180 clinics, we are the region’s largest comprehensive academic health system. Vanderbilt Health has a long tradition of providing world-class care to the people of the Mid-South, living out our mission of moving medicine forward through preeminent programs in patient care, education and research. Here you’ll find a spirit of collaboration and a supportive community where your expertise is valued, your knowledge expanded and your uniqueness celebrated. We are committed to fostering an environment where talented, compassionate people are united in bringing the most advanced care to our neighbors throughout the region.

Organization:

Cardiovascular Med CRE

Job Summary:

Responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance within all policies, under occasional guidance.

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Preferred Skills & Experience

• •Clinical research experience in a patient-facing research setting, with preference given to candidates whose experience extends beyond laboratory-based research.
• •Experience obtaining informed consent and educating patients regarding study participation.
• •Familiarity with CITI training and clinical research compliance requirements.
• •Experience with patient screening, eligibility assessments, and protocol implementation.
• •Knowledge of regulatory processes, IRB requirements, and clinical research documentation.
• •Experience collecting, managing, and maintaining accurate clinical research data.
• •Proficiency with electronic data capture systems, research databases, and related technology platforms.
• •Strong attention to detail with the ability to ensure data quality and regulatory compliance.
• •Excellent communication and collaboration skills with the ability to work effectively with patients, families, investigators, and multidisciplinary teams.

KEY RESPONSIBILITIES

Proficiently 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

Accurately and compliantly prepares and maintains documents required to be maintained internally

and available 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

Identifies and procures equipment and supplies needed to fulfill project requirements (locally

and across multiple sites, if required)

Participates in the determination of eligible candidates for study participation, assuring

participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely

manner through implementing effective screening and recruitment strategies and completing required

documentation. 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

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. Participates in site visits from sponsor, regulatory authorities and others

to review research, source documentation, critical documents and research procedures

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, develops and manages study budgets, monitoring efficient invoicing and taking

appropriate action to maintain clinical trial billing compliance, providing reports investigators,

department administration and funding agencies

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 participants

Participates in the ongoing informed consent process, ensuring that human subjects, their

families, and other health care providers clearly understand what is expected of and from them in

the course of participating in a clinical/translational trial

Participates in research related programs, such as the Clinical/translational Research Staff

Council and its activities by submitting issues or suggesting solutions, and reviewing Council

information, by attending meetings open to research staff and by sharing information with other

research personnel

The responsibilities listed are a general overview of the position and additional duties may be

assigned.

TECHNICAL CAPABILITIES

Clinical Research (Novice): Can research problems that span several areas of the department.

Develops and writes basic trial protocols. Knows what information is available in the company.

Designs data collection forms. Has developed networking skills which assist in researching issues.

Study Design & Conduct (Novice): Applies qualitative and quantitative research methods to perform

preparatory, regulatory, and analytic tasking within the life cycle of a study.

Project Coordination (Novice): Reviews specific project related documents for completeness and

accuracy and ensures project status reports are received, when due, from project managers for all

approved projects. Provides administrative and logistics support for various project meetings,

training, workshops and facilitated sessions. Coordinates and tracks all work requests to ensure on

time project delivery. Keeps project plans updated and ensures key milestones and dependencies are understood. Responsible for record keeping for project meetings such as issues logs, gap analysis sheets, meeting minutes, making copies, team event planning and execution, team travel, on-boarding activities for contractors or consultants, set up and maintenance of project epositories.

Communication (Novice): Clearly, effectively and respectfully communicates to employees or

customers.

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: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has exp