The Division of Hematology Oncology at Vanderbilt University Medical Center is seeking a Clin/Tran Research Coordinator III to support research studies in Stem Cell Transplant and Cellular Therapy.
Assures the integrity and quality of non-therapeutic and non-interventional clinical research in the division. Plans and implements recruitment procedures, manages enrollment of the trial, and ensures compliance with protocols.
This position is a hybrid role, in which you are expected to work in the office four days per week and permitted to work from home one day per week.
- 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.
ADDITIONAL KEY ELEMENTS/RESPONSIBILITIES:
- Point of contact for all studies conducted under the direction of two PIs in Stem Cell Research.
- Serves as Team Lead to other Research Coordinators which includes training and supervising to ensure team is operating efficiently and compliant with all Institutional and Sponsor policies and protocols.
- Develop and implement orientation and training program for new Research Coordinators joining the team.
- Conduct periodic audits of other Research Coordinators to ensure study compliance; Perform additional education as needed.
- Manages the life of the study including site initiation visits, data locks, monitor visits, study close out.
- Possesses knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporation of them in the conduct of research and care of participants.
- Creates study documents such as consents, protocols, training logs, case report forms, etc. Periodically reviews documents for necessary updates and edits as study protocols change.
- Proficiently prepares and processes new research proposals, amendments, continuing review applications, adverse events, budgets, and accounts.
- Digests complex clinical information to determine if documentation is accurate, complete, and to ensure procedures contain appropriate safeguards.
- Records data into electronic data capture system, audits data for accuracy, and resolves queries.
- Conducts multiple studies independently. Utilizes clinical research skills to complete all research protocols, and deliver goal focused, individualized, safe, care as it relates to uncomplicated research participants and with assistance for complicated research participants.
- Coordinates the recruitment of eligible candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
- Provides education and training to appropriate personnel and participants in research specific methodology and procedures.
- Familiarity with cellular therapy, bone marrow stem cell transplant and sickle cell disease
- Utilizes knowledge of disease processes to observe for and report adverse events to the principal investigator and all regulatory authorities as required by protocol, policies and procedures and regulations.
- Develops and manages study budgets and contract negotiations and facilitates interactions between sponsors and institutional departments.
- Prepares and submits invoices to Sponsor; Reviews and audits billing to ensure compliance with clinical trials billing and resolves any billing issues
- 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.