Career Center

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.

POSITION: Full-Time, Non-Exempt

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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 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. It is a place 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.

VUMC Recent Accomplishments

Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:

• US News & World Report: #1 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.
• Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.
• Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.
• The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.
• American Association for the Advancement of Science: The School of Medicine has 112 elected fellows
• Magnet Recognition Program: Received our third consecutive Magnet designations.
• National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement
• Human Rights Campaign Healthcare Equality Index: 6^th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.

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:

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.

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.

COMMUNICATION (FUNDAMENTAL AWARENESS):- Clearly, effectively and respectfully communicates to employees or customers.

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.

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 (P1):

• - 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 (P1):

• - 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 (P1):

• - 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 (P1):

• - 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 (P1):

• - 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 change by keeping an open mind to changing plans and incorporates change instructions into own area of work.

Bachelor's Degree (or equivalent experience) and < 1 year experience

Licensure, Certification, and/or Registration (LCR):

• Additional Qualification Information:
  
  • Prior to advancing to a Clinical/Translational Research Coordinator II, must have completed a Research 101 course such as RSS Boot camp.
  
  
  Physical Requirements/Strengths needed & Physical Demands:
  
  • Light Work category requiring exertion up to 20 lbs. of force occasionally and uses negligible amounts of force to move objects.
  
  
  Movement
  
  • Occasional: Balancing: Maintaining body equilibrium to prevent falling when walking, standing, crouching or maneuvering self, patient and equipment simultaneously while working in large and small spaces
  • Occasional: Climbing: Ascending or descending stairs/ramps using feet and legs and/or hands and arms.
  • Occasional: Kneeling: Bending legs at knees to come to rest on knee or knees.
  • Occasional: Crouching/Squatting: Bending body downward and forward by bending legs and spine. Reaching above shoulders: Extending arms in any direction above shoulders.
  • Occasional: Reaching above shoulders: Extending arms in any direction above shoulders.
  • Occasional: Standing: Remaining on one's feet without moving.
  • Occasional: Push/Pull: Exerting force to move objects away from or toward.
  • Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles
  • Frequent: Carrying under 35 lbs: Transporting an object holding in hands, arms or shoulders, with help of coworkers or assistive device.
  • Frequent: Sitting: Remaining in seated position
  • Frequent: Walking: Moving about on foot.
  • Frequent: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
  • Frequent: Reaching below shoulders: Extending arms in any direction below shoulders.
  • Frequent: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
  • Continuous: Fingering: Picking, pinching, gripping, working primarily with fingers requiring fine manipulation.
  • Continuous: Bimanual Dexterity: Requiring the use of both hands.
  
  
  Sensory
  
  • Occasional: Smell: Ability to detect and identify odors.
  • Occasional: Feeling: Ability to perceive size, shape, temperature, texture by touch with fingertips.
  • Continuous: Auditory: Perceiving the variances of sounds, tones and pitches and able to focus on single source of auditory information
  • Continuous: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.
  • Continuous: Communication: Expressing or exchanging written/verbal/electronic information.
  
  
  Environmental Conditions
  
  • Occasional: Radiation: May be exposed to occupational radiation, requiring enrollment in VUMC's Radiation Safety Program which includes training, use of personal protective equipment with lead shielding, and personal dose monitoring.
  • Frequent: Pathogens: Risk of exposure to bloodborne pathogens and other contagious illnesses.

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