JOB SUMMARY: Supports the activities of the Principal Investigator in accordance with the protocols and regulations. Involved in the collection, interpretation and documentation of data in support of clinical trials. Conducts off-site audits. Initiates and develops process improvements. Trains and mentors new staff members.
Coordinate protocol and patient consent form process.
Coordinates preparation of all IRB and regulatory documents; under direction of PI may draft various communications with Sponsor.
Develops assessment tool pre protocol to use in clinical research.
May assist PI in obtaining Informed Consent from study participant and documents appropriately.
Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary.
Processes patient data and runs reports as needed.
Processes and ships lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards.
Develops procedures for lab collection and storage.
May provide annual reporting to IRB and prepare annual summaries.
Abstracts and records all patient data essential to the study onto required case report forms or into the electronic data collection system.
Sets up timeline of tests and required procedures for nurse.
Inputs all pertinent patient data into database accurately.
Collects and monitors all study patient records to document treatments and outcomes as required by the protocol.
Report all adverse reactions according to VU and protocol guidelines.
Check values from lab and rates toxicity levels.
May coordinate with research investigators, monitors, IRB and sponsors regarding approval process with IRB.
Institutes process improvement measures for efficiency and productivity within the dept.
Initiates and develops new procedures to improve quality and efficiency in the dept.
Trains and mentors new staff to perform job duties at an acceptable level and understand new processes and regulations. Encourages new employees to ask questions to spur process improvement.
Pursues professional development and participate on committees, as requested by management.
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 th...e 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.