Clinical Research Coordinator II (Term Position)

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:

Cardiovascular Medicine

Job Summary:

This is a midlevel patient facing coordinator position that will take a lead role in contents of all aortic valve clinical trials.

Department Summary:

The Division of Cardiovascular Medicine at Vanderbilt University Medical Center (VUMC) is committed to understanding, preventing, and treating cardiovascular disease through: groundbreaking research, providing exceptional patient care, and training the next generation of leaders in cardiovascular medicine.

• Groundbreaking research
• Providing exceptional patient care


A Term position is a staff position that exists for a period longer than six months but is not expected to last beyond one year. Although a position may exist for a specified or indefinite period, staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment, either within the term or when the term ends.

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KEY RESPONSIBILITIES

• 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

• 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

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

• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation. Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation

• 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

• 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

• With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies

• 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

• Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand w