Oncology Translational Trials Coordinator II

Vanderbilt University Medical Center; Nashville (TN); On-site; USD 65,000 - 90,000; Full time

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, under occasional guidance.

The Office of Research at Vanderbilt Health seeks a coordinator to oversee IRB submissions, regulatory documentation, budget support, subject recruitment, and collaboration with investigators and sponsors to advance patient-centered

Qualifications

• Experience coordinating clinical research studies or patient-facing healthcare programs.
• Experience recruiting, screening, and consenting participants/patients.
• Strong patient interaction skills with the ability to build rapport and provide excellent participant support.
• Ability to work independently with minimal supervision; highly organized, self-motivated, and capable of managing priorities autonomously.
• Experience collaborating directly with physicians and healthcare providers.
• Proven ability to manage multiple responsibilities while maintaining attention to detail and regulatory compliance.
• Strong communication and interpersonal skills.
• Oncology experience.

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
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

Skills

Clinical research coordination

Participant recruitment

Patient interaction

Independent work

Physician collaboration

Multi-task management

Communication skills

Oncology experience

Education

Bachelor's degree

Job description

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, under occasional guidance.

The Office of Research at Vanderbilt Health seeks a coordinator to oversee IRB submissions, regulatory documentation, budget support, subject recruitment, and collaboration with investigators and sponsors to advance patient-centered