Job Board
Clin/Tran Research Coord II, Pediatric Neurology
Vanderbilt Health
| Description Clin/Tran Research Coord II ( Pediatric Neurology ) 1909601 JOB SUMMARY: Responsible for coordinating 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, Vanderbilt Policy and Procedure and research protocols. Manages screening, implements recruitment procedures, consent, enrollment, randomization and study conduct from planning through study closeout. Performs or 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. KEY RESPONSIBILITIES: Knowledge and understanding of policies, procedures, and regulations governing human subject's research
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.
Procures equipment for clinical research
Manages Protocols and participates in recruitment/enrollment of study participants
Understands and Implements study protocol
Accurately assesses protocol procedures and ensure clinical research requirements are met
Assess participant eligibility and obtains the informed consent
Arranges schedules and procedures
Completes participant registration
Tracks charges with supervision
Manages study data
Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic - REDCap) 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. Serves as an advocate for human subjects (20%)
Establishes and maintains communication with subjects, investigators, staff, and sponsors
Engages in open communication with participants by providing them with contact information and being available to answer, address or refer their calls.
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 reporting as required by policy, regulations or protocol, to the sponsor and regulatory agencies
Monitors for and reports adverse events in a timely and accurate manner with assistance from senior staff.
Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations
Serve as the primary liaison with the various sponsors (NIH, DOD, etc.).
Oversee quality control, including assuring adequate training of new staff
Coordinate availability of space and supplies
Assist with interviewing new hires and reviewing staff performance
Assist with preparation of abstracts and manuscripts
Preparation and assistance with required progress reports.
Actively identifies and participates in training, education, and development activities to improve knowledge and performance to sustain and enhance professional development.
Initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work
Engages in a minimum of 10 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification Position Qualifications:
Required:
* Bachelor's Degree (or equivalent experience) and 2 year relevant experience
Position Shift:
* Day Shift/ NonExempt Position
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