Clin/Tran Research Coord II

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 diverse 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. 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 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.

Organization:

Psychiatry - Geriatric

Job Summary:

JOB SUMMARY

The Department of Geriatric Psychiatry is seeking a Clinical/Translational Research Coordinator II to join the Center for Cognitive Medicine research team. The Center for Cognitive Medicine is dedicated to improving the lives of patients who suffer from memory loss or may be at risk of developing a memory disorder. This position is unique as it involves the administration of neuropsychological tests to patients and their families. The ideal candidate is someone who is responsible, reliable, and sensible. Candidates should have a familiarity with psychological concepts, a willingness to learn how to administer and score evaluations and can work well with cognitively impaired individuals while also maintaining testing protocol.

The person in this position will also be responsible for coordinating the approval processes and conduct of multiple research protocols, such that the integrity and quality of the clinical/translational research is maintained, and the research is conducted in accordance with all policies, under occasional guidance. The ideal candidate will be flexible and adaptable, focused on quality, detailed oriented, a problem solver, and able to interact comfortably with patients, colleagues, MDs and administrative personnel.

This position is eligible for a Hybrid work schedule. Availability to work remotely will be determined by what visits are scheduled week to week, and actual days of remote work will vary and are not guaranteed.

.

KEY RESPONSIBILITIES

•    Proficiently prepare and process 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 prepare and maintain documents for review by internal, regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. 
•    Participate in periodic site visits from sponsor, regulatory authorities, and others to review research, source documentation and research procedures.
•    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.
•    Ability to identify and troubleshoot problems.
•    Records data from 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.
•    Understands the implementation, coordination, management and reporting of clinical/translational research operations.
•    Assess and evaluate potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation.
•    Engage in open communication with participants by providing them with contact information and being available to answer, address or refer their calls.
•    Knowledgeable of the safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies. In a timely fashion, monitor, detect and report adverse events meeting requirements of regulatory bodies. Coordinate activities and gather information from a variety of sources to achieve stated outcomes.
•    Perform packaging and shipment of study specimens (blood, urine, etc.) to the sponsor or lab in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation.
•    Foster c