A full-time Clin/Tran Research Coordinator III is sought to work as part of an energetic and fast-paced team of clinical researchers in Orthopaedic Surgery. An experienced research coordinator with advanced knowledge of clinical research study operations is needed to join our central Orthopaedic Clinical Research (OCR) team to support department-wide research/quality initiatives and serve as the lead coordinator for our Total Joints and Oncology divisions.
As part of the OCR team, the coordinator will be responsible for managing/overseeing quarterly data uploads for the AAOS registries, assisting with centralized, department pre-review of IRB submissions for all Ortho divisions, and helping to create/establish new department-wide research resources, workflows, and SOPs. As lead coordinator for the Joints and Oncology divisions, this position will: (1) work closely with the division faculty Research Leads to track, assess the feasibility, and guide the development/implementation of proposed new research projects within the division; (2) assist division PIs with creating study documents (protocol, case report forms, consent and recruitment documents, etc.) and IRB submissions; (3) oversee the implementation, data management, regulatory compliance and financial administration of division studies - including charge reconciliation and sponsor invoicing if applicable; and (4) supervise the work of junior research staff &/or residents assigned to division research studies. The coordinator will also assist directly with subject recruitment, consent, data collection/management, sample processing/shipping, general study management as needed and help support various ongoing department-wide projects as needed.
Our Division of Orthopaedic Trauma provides immediate and ongoing care for patients with traumatic injuries -- treating more than 4,500 adults and children each year at our Level I trauma center, many with multiple injuries.
Our high-volume program provides excellent opportunities for training residents and fellows. Our program is designed to teach you to quickly assess patients and provide effective emergency care, from delivering today's most advanced and promising surgical treatments to helping patients and their families know what to expect and how to adjust before, during and after treatment.
POSITION SUMMARY: Full-Time, Exempt
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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. Participates in data quality assurance reviews.
Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures
Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
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. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools
Receives and tracks receipt and status of study specimens from multiple sites. 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
Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation
With department administration, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to 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 public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants. With guidance, assesses and evaluates potential participants pertinent medical and historical information.
Assesses for and implements process improvement initiatives within a clinical/translational trial and a department to assure research quality, and expedient completion of recruitment, timely receipt of research related payments and cost savings and expedient study reporting
Defines and uses metrics to drive performance improvement. Shares metrics with investigators and administrators to demonstrate areas in need of improvement and tracks metrics to demonstrate effectiveness of improved processes
The responsibilities listed are a general overview of the position and additional duties may be assigned.
CLINICAL RESEARCH (INTERMEDIATE):- Demonstrates the ability to effectively research complicated issues pertaining to the area of expertise. Presents trial protocols to a steering committee. Often employs networking to help in researching issues. Sets up study centers, which includes ensuring each center has the trial materials and training site staff to trial-specific industry standards. Has used research resources maintained in outside areas.
PROJECT COORDINATION - (INTERMEDIATE):- Performs project tracking and reporting relative to task completion dates, dependency effects, problem anticipation, schedule conflicts, and assignment to appropriate staff for resolution. Manages prioritization procedures for changing scope [i.e., change management] and project acceptance procedures. Measures progress toward goals and revises project objectives and documents applying change control procedures. Assumes responsibility [as appropriate] for resolving issues and seeing work through to successful completion. Provides training to project managers and others on project related templates and toolsets. Develops methods to measure customer satisfaction and obtains feedback at critical milestones and at project completion to ensure project efforts meet customer expectations.
COMMUNICATION (INTERMEDIATE):- Clearly, effectively and respectfully communicates to employees or customers.
STUDY DESIGN & CONDUCT (INTERMEDIATE):Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
PEOPLE MANAGEMENT - (NOVICE):- Conducts performance reviews. Effectively delegates tasks to others. Coaches subordinates on technical and interpersonal topics, as well as professional development. Demonstrates team building techniques and provides leadership through personal example of good work habits, open communication and effective people relationships. Involves subordinates in decisions which affect them. Demonstrates self-reliance and resourcefulness as an example to others.
Organizational Impact: Independently delivers on objectives with understanding of how they impact the results of own area/team and other related teams.
Problem Solving/ Complexity of work: Utilizes multiple sources of data to analyze and resolve complex problems; may take a new perspective on existing solution.
Breadth of Knowledge: Has advanced knowledge within a professional area and basic knowledge across related areas.
Team Interaction: Acts as a go-to resource for colleagues with less experience; may lead small project teams.
SUPPORTING COLLEAGUES (P3):
- Develops Self and Others: Invests time, energy and enthusiasm in developing self/others to help improve performance 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 (P3):
- 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 (P3):
- 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 (P3):
- 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 (P3):
- 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.
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period. Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. 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.As t...he largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.