Organization:

Neurology Admin 30

Job Summary:

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 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. Travel to Investigator and Study Coordinator meetings, be on call monthly to cover clinical trials via phone or in-person. Complete sponsor protocol and database trainings, mRS, and NIHSS trainings.

.

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 trials 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 trials. 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 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 w 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 while participating in a clinical 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 goals.

BASIC QUALIFICATIONS

• Bachelor's Degree (or equivalent experience) (Required)
• 2 years' experience (Required)
• Prior to advancing to a Clinical/Translational Research Coordinator III, must have completed a Research 101 course such as RSS Boot camp; applicant/new hire must complete a Research 101 course within six (6) months of hire.

PHYSICAL REQUIREMENTS/STRENGTHS NEEDED & PHYSICAL DEMANDS

Movement

• Occasional: Sitting: Remaining in seated position, Standing: Remaining on one's feet without moving., Walking: Moving about on foot., Lifting under 35 lbs.: Raising and lowering objects under 35 lbs. from one level to another, Push/Pull: Exerting force to move objects away from or toward., Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles, Reaching below shoulders: Extending arms in any direction below shoulders., Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.

Our Academic Enterprise is one of the nation's longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.

World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.

Aligning with Vanderbilt Health's Strategic Directions, the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.

Core Accountabilities:

Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area. Team Interaction: Provides informal guidance and support to team members.

Core Capabilities :

Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.

Position Qualifications:

Responsibilities:

Certifications :

Work Experience :

Relevant Work Experience

Experience Level :

Less than 1 year

Education :

Bachelor's

For a copy of the physical requirements of this position to determine if you can perform the duties with or without an accommodation or to request an accommodation, please contact VUMC Employee Relations at 615-343-4759 or employeerelations.vumc@vumc.org.