Clin/Tran Research Coord II, Nephrology

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.

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• Job Description

  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 for or concerned about protections for human participants of research and through ongoing monitoring of trial processes and 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 repositories.
  • Communication (Novice): Clearly effectively and respectfully communicates to employees or customers.
• Additional Job Description

  Additional Job Description
  PHYSICAL REQUIREMENTS
  Light Work category requiring exertion up to 20 lbs. of force occasionally and uses negligible amounts of force to move objects.
  
  
  PHYSICAL DEMANDS
  Pathogens: Risk of exposure to bloodborne pathogens and other contagious illnesses. - Frequent
  Chemicals and Gasses: Medications cleaning chemicals oxygen other medical gases used in work area. - Not Applicable
  Climate: Ability to withstand exposure to atmospheric extremes including heat cold humidity and barometric pressure changes. - Not Applicable
  Radiation: May be exposed to occupational radiation requiring enrollment in VUMCs Radiation Safety Program which includes training use of personal protective equipment with lead shielding and personal dose monitoring. - Occasional
  Bimanual Dexterity: Requiring the use of both hands.
  - Continuous
  Dust - Not Applicable
  Vibration: Subject to oscillating movement. - Not Applicable
  Proximity to moving mechanical parts - Not Applicable
  Mist - Not Applicable
  Odor - Not Applicable
  Electrical current - Not Applicable
  Working in high exposed places - Not Applicable
  Sitting: Remaining in seated position - Frequent
  Walking: Moving about on foot. - Frequent
  Standing: Remaining on ones feet without moving. - Occasional
  Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another - Frequent
  Carrying under 35 lbs: Transporting an object holding in hands arms or shoulders with help of coworkers or assistive device. - Frequent
  Lifting over 35 lbs: Raising and lowering objects from one level to another includes upward pulling over 35 lbs with help of coworkers or assistive device - Not Applicable
  Push/Pull: Exerting force to move objects away from or toward. - Occasional
  Carrying over 35 lbs: Transporting an object holding in hands arms or shoulders with help of coworkers or assistive device. - Not Applicable
  Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles - Occasional
  Climbing: Ascending or descending stairs/ramps using feet and legs and/or hands and arms. - 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
  Crawling: Moving about on hands and knees or hands and feet. - Not Applicable
  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 above shoulders: Extending arms in any direction above shoulders. - Occasional
  Reaching below shoulders: Extending arms in any direction below shoulders. - Frequent
  Reaching above shoulders: Extending arms in any direction above shoulders. - Occasional
  Handling: Seizing holding grasping turning or otherwise working with hand or hands. - Frequent
  Fingering: Picking pinching gripping working primarily with fingers requiring fine manipulation. - Continuous
  Communication: Expressing or exchanging written/verbal/electronic 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
  Auditory: Perceiving the variances of sounds tones and pitches and able to focus on single source of auditory information - Continuous
  Smell: Ability to detect and identify odors. - Occasional
  Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels requiring enrollment in VUMCs Hearing Conservation Program which includes training use of hearing protection and periodic audiometry. - Not Applicable
  Taste: Ability to detect quality texture consistency and taste of prepared foods/quality control. - Not Applicable
  Feeling: Ability to perceive size shape temperature texture by touch with fingertips. - Occasional

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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.