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 of diverse individuals 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 recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and where your diversity of culture, thinking, learning, and leading is 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. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Organization:

Clinical Pharmacology - Lab

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, with some guidance.

Department Summary:

The mission of the Division of Clinical Pharmacology at Vanderbilt University Medical Center (VUMC) is to understand the mechanisms of drug action in humans in order to improve therapeutics. One of the oldest and largest divisions of its kind, our division bridges basic and clinical sciences through translational research and robust training in clinical pharmacology.

Through research, the division attempts to understand how basic molecular, biochemical and cellular processes are altered in various pathological conditions, and seeks to identify novel therapeutic interventions for human diseases.

• Faculty publish extensively, with their work appearing in prestigious journals,

including Nature, the New England Journal of Medicine, Proceedings of the

National Academy of Sciences and the Journal of Clinical Investigation

• In addition to conducting state-of-the-art research, faculty lead many

institutional and national efforts to train clinical and translational

investigators, and to support infrastructure for translational research

In recognition of their contributions, six faculty have been elected to the Associate of American Physicians.

The division’s dynamic fellowship programs are designed to rigorously train individuals interested in pursuing careers in clinical pharmacology. With more than 27 fellows in the program, Vanderbilt ranks as a leader in the training of clinical pharmacologists for academia, industry and government. Since its founding in 1963, the division has trained over 350 fellows, which is more than any other clinical pharmacology program in the world.

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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 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

• 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.

The individual in this position will perform a variety of duties involved in conducting clinical studies in accordance with federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. They will be responsible for coordinating all the recruitment activities, conducting interviews with potential participants, attend meetings or events in the community for recruitment purposes, develop strategies for identifying and engaging member of the community in the participation of a research project.

Manages screening, consent volunteers, maintains accurate and timely documentation and communication with volunteers, research nurse and investigators, participants, IRB and other research related entities.

Responsibilities

Under supervision of the PI the research coordinator:

Implement recruitment procedures (advertisement through e-mail, radio, distribution of adds in different events and clinics)

Assess patient eligibility and enroll applicable patients

Supervise the circulation of subject study data

Manage student assignments

Performs data entry as necessary and required for study data

Engages in open communication with participants by providing them with contact information and being available to answer, address or refer their calls

Furthers knowledge by completing more advanced job-related educations (such as Research Support Services Boot camp Follow-up). Actively seeks new learning opportunities, seeing learning as a part of work. Develops and achieves personal and professional goals

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 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 :

Bachelor's

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled