Clinical Research Coordinator III - Hematology/Oncology

Vanderbilt University Medical Center•Nashville, TN

10d

About The Position

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 of individuals 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 uniqueness is 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. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research. Organization: Hematology/Oncology Research Job Summary: Responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance within all policies, independently. . Department Summary: The Division of Hematology and Oncology at Vanderbilt University Medical Center conducts research and treats all types of adult cancers including solid tumor cancers and hematological (blood) disorders, as benign hematologic disorders such as coagulation disorders and non-cancerous blood diseases. With over 80 faculty members representing a broad range of professional expertise, our dedicated team of professionals is committed to hematologic and oncologic care through: Research to better understand and treat cancers and benign hematologic diseases Translating VICC laboratory research into therapies to help people with cancer State-of-the-art patient care and personalized cancer therapy Clinical trials, including Phase I drug development with subsequent Phase II and Phase III testing Training future hematology and oncology doctors and researchers Cancer chemotherapy, pharmacology, and biological therapy with an emphasis on solid tumors Treating bleeding and coagulation disorders, anemia and other disorders of blood

Requirements

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.
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.
Study Design & Conduct (Intermediate): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
Communication (Intermediate): Clearly, effectively and respectfully communicates to employees or customers.
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.
Responsibilities:
Certifications :
Work Experience :
Relevant Work Experience Experience Level : 3 years
Education : Bachelor's

Responsibilities

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.