Clinical/Translational Research Coordinator III - Lung Transplant

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. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness 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:

Allergy, Pulmonary and Critical Care Medicine

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. The candidate will work on studies involving lung transplant candidates and recipients and management of organ donors.

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*This position is not eligible for visa sponsorship.

KEY RESPONSIBILITIES

• 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.

• 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.

• Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations.

• 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/translational trial.

• Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures. Participates in data quality assurance reviews.

• Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures.

• Engages in open communication with participants by providing them with contact information and being available to answer, address or refer their calls.

• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required).

• Learns and then teaches phlebotomy to the study team, obtains blood samples from enrolled patients, as needed. Learns procedures for collection, processing, and storage of clinical samples.

• Records data from source documentation and/or participant interaction onto case report forms with awareness and attention to the requirements for accuracy, completeness and timeliness.

• Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools.

• Receives and tracks receipt and status of study specimens from multiple sites. 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.

• Knowledgeable of the safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adv