Vanderbilt University Medical Center · 1 month ago
Clinical Research Coordinator I - Hematology/Oncology
Nashville, TN
Full-time
Onsite
Entry Level
1+ years expVanderbilt University Medical Center is located in Nashville, Tennessee, and is dedicated to advancing health and wellness through innovative research and patient care. The Clinical Research Coordinator I is responsible for coordinating the approval processes and conduct of oncology clinical research protocols, ensuring compliance with regulations and maintaining the integrity of research.
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Responsibilities
Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subjects' research and incorporates them in the conduct of research
Possesses a basic awareness of the Federal regulations and guidelines governing the protection of human subjects (e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations), before engaging in human subjects research
With assistance, 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
Communicates a basic knowledge and understanding of the management and implementation of clinical/translational research operations
Exhibits the capability to understand and follow a clinical/translational study protocol, obtaining training and seeking assistance when needed, to safely and accurately perform or assess required protocol procedures. Uses coordination skills and works collaboratively with study participants, other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures
Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/or the sponsor before, 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
Procures equipment and supplies needed to fulfill project requirements
Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements
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
Develops and maintains patient databases, investigational logs, and records of procedures followed
Familiar with the safety reporting requirements of the study protocol, FDA, and other regulatory bodies. In a timely fashion, monitors, detects, and reports adverse events, meeting the requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
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 assists with study completion, study closeout 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
With supervision, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance
Assists the Principal Investigator in the development of study protocols
Collaboratively participates in study team meetings. Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors
Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis
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
With guidance, 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. Engages in open and positive communication with study participants and coworkers
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
Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance
Supervises, mentors and trains new or junior research staff/interns
Encourages open communication with participants by providing them with contact information and being available to answer, address or refer their calls
With direction, performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and in a timely manner reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other safety reporting to appropriate funding/regulatory agencies is required
Utilizes or obtains knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to continue education (i.e., in-services, seminars, etc.)
Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work
Engages in a minimum of 5 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification
Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor
Participates in research-related programs, such as the Clinical/Translational Research Staff Council, by reviewing information and attending meetings open to research staff
Furthers knowledge base by attending a Basic Research 101 within the first three months of employment date
Qualification
Required
Bachelor's Degree (or equivalent experience)
< 1 year professional research experience
Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills
Preferred
Phlebotomy experience
Prior experience in coordinating hematology/oncology studies
Company
Vanderbilt University Medical Center
Vanderbilt University Medical Center is a nonprofit institution specializing in patient care, research, and nobility in medical education.
10001+ employees
H1B Sponsorship
Vanderbilt University Medical Center has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (92)
2024 (74)
2023 (73)
2022 (113)
2021 (96)
2020 (70)
Funding
Current Stage
Late StageTotal Funding
$35.3MKey Investors
National Institute on AgingAdvanced Research Projects Agency for HealthGordon and Betty Moore Foundation
2025-07-02Grant· $25M
2024-11-15Grant· $3.3M
2024-09-13Grant
Leadership Team
Wright Pinson
Deputy CEO and Chief Health System Officer
Cecelia Moore
Chief Financial Officer & Treasurer
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