Clinical Research Coordinator II - Hematology/Oncology

Vanderbilt University Medical Center•Nashville, TN

14h•Onsite

About The Position

Vanderbilt University Medical Center (VUMC), located in Nashville, Tennessee, is a global crossroads of teaching, discovery, and patient care, committed to advancing health and wellness through preeminent programs in patient care, education, and research. VUMC fosters an environment where expertise is valued, knowledge expanded, and abilities challenged, ensuring everyone has the chance to thrive. The organization is the largest private employer in Middle Tennessee, employing over 28,000 people across various clinical, research, and supporting roles. The Clinical Research Coordinator II role is responsible for coordinating the approval processes and conduct of research protocols, ensuring the integrity and quality of clinical/translational research is maintained and conducted in accordance with all policies, under occasional guidance. The Division of Hematology and Oncology at VUMC, where this position is located, conducts research and treats all types of adult cancers, including solid tumor cancers and hematological (blood) disorders, as well as benign hematologic disorders. With over 80 faculty members, the dedicated team is committed to hematologic and oncologic care through research to better understand and treat diseases, translating laboratory research into therapies, providing state-of-the-art patient care and personalized cancer therapy, conducting clinical trials (including Phase I, II, and III drug development), and training future hematology and oncology doctors and researchers. This includes a focus on cancer chemotherapy, pharmacology, biological therapy for solid tumors, and treating bleeding/coagulation disorders, anemia, and other blood disorders.

Requirements

Proficient in Clinical Research (Novice level): 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, and has developed networking skills.
Proficient in Study Design & Conduct (Novice level): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
Proficient in Project Coordination (Novice level): Reviews specific project related documents for completeness and accuracy, ensures project status reports are received, provides administrative and logistics support for various project meetings, training, workshops and facilitated sessions, coordinates and tracks all work requests, keeps project plans updated, ensures key milestones and dependencies are understood, and is responsible for record keeping for project meetings.
Proficient in Communication (Novice level): Clearly, effectively and respectfully communicates to employees or customers.
1 year of relevant work experience
Bachelor's degree

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