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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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.
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.
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.
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
Light Work category requiring exertion up to 20 lbs. of force occasionally and uses negligible amounts of force to move objects.
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.
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.
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
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period. Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. 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.As t...he largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.