Clin/Tran Research Coordinator II

Vanderbilt Health • Nashville, TN

368d

About The 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 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.

Requirements

• Bachelor's degree required.
• 1 year of relevant work experience.
• Proficient in clinical research processes and regulations.
• Ability to communicate effectively and respectfully.
• Strong organizational and project coordination skills.

Nice To Haves

• Experience in clinical/translational research.
• Familiarity with IRB processes and regulatory compliance.
• Networking skills to assist in researching issues.

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.
• 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.
• 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.
• 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.
• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations.
• Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of them.
• Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities.

Benefits

• Inclusive work environment.
• Opportunities for professional development.
• Commitment to diversity and equal opportunity.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees