Clinical/Translational Research Coord II- Hybrid

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As one of the largest clinical programs in the nation, the Vanderbilt Department of Anesthesiology provides clinical care for the full spectrum of procedural, critical care, pain management, and perioperative medicine needs for more than 60,000 adult and pediatric patient encounters annually at more than 90 anesthetizing locations. Each year, nearly 20,000 patients are seen in the Vanderbilt Preoperative Evaluation Clinic (VPEC). Approximately 3,000 patients are seen annually in our Vanderbilt Interventional Pain Center, and approximately 20,000 Vanderbilt adult and pediatric patients receive an anesthetic during a radiologic, gastrointestinal, or other diagnostic or therapeutic procedure. Our faculty, residents, fellows, Certified Registered Nurse Anesthetists (CRNAs), and nurse practitioners provide care in six adult intensive care units, the pediatric and neonatal intensive care units, and perform more than 3,100 anesthetics per year in the labor and delivery suite. For more information, please visit https://www.vumc.org/anesthesiology/clinical-care-0.

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 what is expected of and from them in the course of participating in a clinical/translational trial
• Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

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This role offers the opportunity to make a meaningful impact within Vanderbilt Health, supported by a comprehensive benefits package which may include health, disability, retirement and/or wellness offerings to enhance your well-being and professional growth.

Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity.  EOE/Vets/Disabled.