Clinical Research Coordinator II - Hematology/Oncology (Term Position)

About the Organization

Vanderbilt University Medical Center (VUMC), located in Nashville, Tennessee, is a global leader in teaching, discovery, and patient care. The Division of Hematology and Oncology conducts research and treats all types of adult cancers, including solid tumor cancers and hematological disorders, as well as benign hematologic conditions such as coagulation disorders and non-cancerous blood diseases. With over 80 faculty members, the division is dedicated to:

• Research to better understand and treat cancers and benign hematologic diseases
• Translating 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 blood disorders

This is a term position expected to last longer than six months but not beyond one year, with no guarantees of continued employment.

About the Role

Responsible for coordinating the approval processes and conduct of research protocols to maintain the integrity and quality of clinical/translational research. The role ensures research is conducted in accordance with all policies and federal regulations, under occasional guidance.

Responsibilities

• Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional, departmental, and federal regulations.
• Accurately and compliantly prepares and maintains documents required for regulatory authorities and/or sponsors before, during, and after clinical/translational trials.
• Participates in periodic site visits from sponsors, 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 determining eligible candidates for study participation, ensuring participants meet eligibility requirements. Implements effective screening and recruitment strategies to ensure timely study completion.
• Assesses and evaluates potential participants' medical and historical information to ensure appropriate enrollment and continued eligibility in clinical/translational trials.
• Records data from source documentation and/or participant interaction onto case report forms (paper or electronic) with accuracy, completeness, and timeliness. Resolves queries promptly.
• Ensures research information is collected and stored in compliance with regulations, policies, and good clinical practice.
• Performs packaging and shipping of study specimens (e.g., blood, urine) to sponsors or laboratories in accordance with guidelines and regulations, maintaining appropriate documentation.
• Develops and manages study budgets with direction, monitors efficient invoicing, and ensures clinical trial billing compliance. Provides reports to investigators, department administration, and funding agencies.
• Serves as an advocate for human subjects by maintaining communication with investigators, research staff, sponsors, participants, and professional organizations concerned with protections for human research participants.
• Participates in the ongoing informed consent process, ensuring participants, their families, and healthcare providers clearly understand expectations.
• Engages in research-related programs, such as the Clinical/Translational Research Staff Council, by submitting issues, suggesting solutions, attending meetings, and sharing information with other research personnel.

Core Accountabilities

• Organizational Impact: Executes job responsibilities with an understanding of how output affects other areas related to the job or team, with occasional guidance.
• Problem Solving: Analyzes moderately complex problems using technical experience and judgment.
• Breadth of Knowledge: Possesses 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 by investing time and energy to improve performance and gain knowledge.
  • Maintains regular contact with key colleagues and stakeholders to build and strengthen relationships.
  • Recognizes group interactions and modifies communication style to suit different situations and audiences.
• Delivering Excellent Services:
  • Seeks to understand current and future needs of stakeholders and customizes services accordingly.
  • Approaches problems from different angles to identify new opportunities and develop concrete solutions.
  • Provides ongoing support and coaching to increase employees' effectiveness.
• Ensuring High Quality:
  • Engages in dialogue about quality and addresses issues promptly.
  • Applies learning experiences to uncover underlying causes of problems and identify improvement opportunities.
  • Understands and fulfills safety and regulatory requirements to maintain a safe environment.
• Managing Resources Effectively:
  • Demonstrates accountability by focusing on and driving critical issues to closure.
  • Applies understanding of departmental work to manage resources effectively.
  • Makes data-driven decisions to identify and elevate opportunities.
• Fostering Innovation:
  • Proactively identifies new ideas and opportunities to improve processes beyond conventional approaches.
  • Demonstrates enthusiasm for learning new technologies, tools, and procedures.
  • Views difficult situations as opportunities for improvement and embraces change.

Requirements

• Bachelor's degree
• 1 year of relevant work experience

Benefits

This role offers a comprehensive benefits package, which may include health, disability, retirement, and/or wellness offerings to enhance well-being and professional growth.