Clinical Research Coordinator II - VCC - VICTR

JOB SUMMARY
In your pivotal role as a Clinical Research Coordinator 2, you will coordinate the approval processes and conduct of research protocols, assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, VUMC policies and procedures, and research protocols.

About the Department:

The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. The VCC first began in 1989 under the direct leadership of Dr. Gordon Bernard. Its initial focus was on providing coordinating center support for investigator-initiated trials overseen at Vanderbilt. In 2016, with the addition of several large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR) and due to an ever-growing need to provide more specialized, flexible support to Vanderbilt investigators, a need surfaced to reinstate the VCC. For more information, please visit https://vcc.vumc.org.

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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

• Manages screening, implements recruitment procedures, consent, enrollment, randomization and study conduct from planning through study closeout.
• Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
• Performs and implements processes to assure study-related procedures are performed as required and objectives and timelines are met.
• Maintains accurate and timely documentation and communication with Investigators, participants, IRB, sponsors, and other research related entities.

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

TECHNICAL CAPABILITIES

PATIENT RECRUITMENT (INTERMEDIATE)

Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. 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. Accurately and compliantly performs the procedures required of each study protocol, deviating from the protocol only when a subject's safety is at risk and reporting as required by policy, regulations or protocol, to the sponsor and regulatory agencies. Reports adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations. 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 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.

REGULATORY COMPLIANCE (INTERMEDIATE)

Possesses knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research. Possesses knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH, and HIPAA regulations. 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. Possesses knowledge and understanding of the implementation, coordination, management and reporting of clinical research operations. Knowledgeable of the safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies.

DOCUMENTATION (INTERMEDIATE)

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 trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures. 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.

CONTINUAL LEARNING (INTERMEDIATE)

Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, etc.). Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Engages in a minimum of 10 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification. Participates in and maintains certifications, licensure and credentialing as required by VUMC, the department and sponsor.

BASIC QUALIFICATIONS

• Bachelor's Degree (or equivalent experience) (Required)
• 2 years relevant experience (required)

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; applicant/new hire must complete a Research 101 course within six (6) months of hire.

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.

• 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.