Pediatric Neurosurgery Clin/Tran Research Coord II

Surgical Outcomes Center for Kids (SOCKs)

SOCKs was born out of a need to provide a readily accessible research infrastructure available to pediatric surgeon-scientists. The overarching goal is to: 1) assess surgical and patient-centered outcomes that can inform future clinical decision making, 2) identify standards of excellence and best practices that can improve overall patient health, and 3) implement quality improvement initiatives creating opportunities for effective resource utilization for the healthcare system as a whole. This research infrastructure has allowed our surgeon-scientists to merge their research and clinical interests, increasing academic productivity and participation in academic meetings on the national level, while continuing to move the clinical enterprise forward. The leadership consists of a senior level epidemiology center director, a surgeon-scientist medical director, and program director with expertise in clinical trials and outcomes research management. The SOCKs team includes masters level research managers, data specialists, biostatisticians and research assistants. Expertise provided includes hypothesis and aims generation, protocol development, studydesign development and sample size calculations, recruitment and enrollment, data management, grant writing, all regulatory aspects and oversight, statistical analysis, results interpretation and dissemination including abstract presentation and manuscript development. In addition to personnel, expertise, and infrastructure, SOCKs maintains the highest regulatory standards to ensure patient privacy & confidential study documentation. Since the program launched in 2015, we have successfully published over 130 manuscripts, started over 170 clinical research projects from retrospective and RCTs to qualitative and cost effectiveness. We currently collaborate with over 75 surgeons and physician scientists and researchers, as well as maintain 10 multi-institutional research networks across subspecialties. In addition to the day to day operations of SOCKs, the training program has exploded since 2015 becoming a central focus of the SOCKs mission. The SOCKs Research Trainee Program provides invaluable experiences for on-campus students (medical, graduate and undergraduate), clinical residents and fellows as well as year-out and international research fellows, and of course our Summer Research Institute. More than 120 trainees from diverse backgrounds have been mentored through SOCKs in the past five years representing more than 25 schools from across the United States.

JOB SUMMARY:

Join a dynamic team in the Division of Pediatric Neurosurgery which includes four attending surgeons, two mid-level providers, and a multitude of dedicated administrative and clinic staff. As the team's research efforts continue to expand, we are looking for a motivated, independent research professional to proactively manage this growing initiative.

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.

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
• Understanding and capability to accurately and compliantly perform the procedures required of each study protocol, working collaboratively with study participants, other staff and departments, in safely and accurately performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage, etc. Ability to identify and troubleshoot problems
• 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
• 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
• Knowledgeable of the safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
• 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
• 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
• 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
• Engages in open communication with participants by providing them with contact information and being available to answer, address or refer their calls
• Performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reporting as required by policy, regulations or protocol, to the sponsor and regulatory agencies
• Utilizes or acquires knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
• Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, etc.)
• Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work
• Engages in a minimum of 10 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification
• Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor
• 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
• Furthers knowledge by completing more advanced job-related educations (such as Research Support Services Boot camp Follow-up). Actively seeks new learning opportunities, seeing learning as a part of work. Develops and achieves personal and professional goal