Clinical Translational Research Coordinator II - ON SITE
Clinical Translational Research Coordinator II - ON SITE
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Job Description
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 ofindividuals 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 uniquenessis 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. Vanderbilts mission is to advance health and wellness through preeminent programs in patient care education and research.
Organization:
Orthopaedic Surgery & RehabJob Summary:
This is a full-time position in the Department of Orthopaedic Surgery Kristin Archer PhD Principal investigator. A coordinator with at least 1 year (preferably 2-5 years) of clinical research is needed on the team to support multi-center randomized clinical trials funded by the Department of Defense (DoD). The coordinator will enroll and follow study subjects undergoing spine surgery at VUMC and will assure compliance with the study protocols. Responsibilities will include maintaining and updating study protocol; overseeing IRB initial submission amendments and continuing review; recruitment and follow-up of patients; ongoing communication with the PI spine surgeons and rehabilitation providers to ensure adherence to study protocols; and overseeing weekly meetings with the PI co-investigators and study staff to report on study progress.Key Functions and Expected Performances:
Maintain accurate and timely documentation of study procedures and communication with investigators and federal sponsors
Maintain IRB documentation and ensure research is conducted in accordance with Good Clinical Practice Guidelines and sponsor guidelines
Recruit appropriate individuals for study participation according to study protocol which involves medical chart review and patient screening or interviewing
Enroll eligible study participants
Complete assessment procedures with study participants in clinic or remotely
Schedule participants for initial and/or follow-up appointments
Conduct follow-up calls emails or mailings related to study activities
Communicate regularly and effectively with investigators and other members of the research team on an ongoing basis related to study protocol.
Maintain study database
Attend weekly research team meetings
Contribute to a positive work environment
REQUIRED:
- Bachelors Degree (or equivalent experience)
- Minimum 1 year of relevant experience; 2-5 years preferred
- Ongoing access to reliable transportation
- Experience in REDCap is a plus
This position will work traditional daytime business hours Monday-Friday.
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DEPARTMENT SUMMARY:
In the Department of Orthopaedic Surgery at VUMC each year we provide 110000 outpatient visits and manage 11500 surgical cases all with a passion for equipping the next generation of orthopaedic surgeons and for making a difference in the lives of the people we serve. For additional information please visit 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.
TECHNICAL CAPABILITIES
- Clinical Research (Novice): Can research problems that span several areas of the department. Develops and writes basic trial protocols. Knows what information is available in the company. Designs data collection forms. Has developed networking skills which assist in researching issues.
- Study Design & Conduct (Novice): Applies qualitative and quantitative research methods to perform preparatory regulatory and analytic tasking within the life cycle of a study.
- Project Coordination (Novice): Reviews specific project related documents for completeness and accuracy and ensures project status reports are received when due from project managers for all approved projects. Provides administrative and logistics support for various project meetings training workshops and facilitated sessions. Coordinates and tracks all work requests to ensure on time project delivery. Keeps project plans updated and ensures key milestones and dependencies are understood. Responsible for record keeping for project meetings such as issues logs gap analysis sheets meeting minutes making copies team event planning and execution team travel on-boarding activities for contractors or consultants set up and maintenance of project repositories.
- Communication (Novice): Clearly effectively and respectfully communicates to employees or customers.
Our Academic Enterprise is one of the nations 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 HealthsStrategic Directions the Office of Research providesshared research resourcesadministrative expertiseand professional guidance to enablethetrans-disciplinary environment and highly collaborative culture that advances discovery and training forall 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 ones 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 ExperienceExperience Level :
1 yearEducation :
BachelorsVanderbilt Health is committed tofosteringan environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.
Required Experience:
IC
Employment Type
Full-Time
