Clinical Research Coordinator 1 & 2 -100% Onsite

Vanderbilt University Medical Center•Nashville, TN

1d•Onsite

About The Position

Vanderbilt University Medical Center (VUMC), located in Nashville, Tennessee, is a global crossroads of teaching, discovery, and patient care. VUMC is committed to fostering an environment where individuals can thrive, and their unique contributions are valued. The organization's mission is to advance health and wellness through preeminent programs in patient care, education, and research. This role is within the Neurology Admin 20 division, which is dedicated to training the next generation of clinicians, scientists, and research professionals. The division offers extensive education and professional development opportunities for research coordinators, residents, fellows, graduate students, postdoctoral trainees, and students exploring careers in neuroscience, medicine, neuropsychology, and nursing. Team members engage in various experiences, including weekly meetings, seminars, protocol trainings, and journal clubs. They also observe clinical evaluations, non-invasive procedures, neuroimaging, and cognitive assessments. Opportunities are available for hands-on experience and training in good clinical practice (GCP), human subjects protections, regulatory processes, biospecimen handling, cognitive testing, and clinical data collection. Mentorship from faculty, research managers, and staff is also provided. This position is ideal for candidates interested in neurology, neuropsychology, neuroscience, or medicine seeking hands-on clinical research experience in a collaborative academic environment.

Requirements

Skills in organization, problem solving, effective communication, and motivation are highly desired
Strong interpersonal skills in empathy and comfort working with individuals with cognitive and movement
Bachelor's degree
Less than 1 year of relevant work experience
Fundamental Awareness in Project Coordination: Has light experience, training, direct exposure, or past experience with Project Coordination. Has worked on at least one project in a support role. Collects and collates project related material such as project initiation documents, project status reports, project metrics, and project completion data.
Fundamental Awareness in Study Design & Conduct: Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
Fundamental Awareness in Communication: Clearly, effectively and respectfully communicates to employees or customers.
Fundamental Awareness in Clinical Research: Knows the primary resources available to accomplish the job. Can successfully research simple clinical questions pertaining to the functional area. Files and collates trial documentation and reports. Archives study documentation and correspondence. Demonstrates a systematic approach to problem solving.
Develops Self and Others: Continuously improves own skills by identifying development opportunities.
Builds and Maintains Relationships: Seeks to understand colleagues priorities, working styles and develops relationships across areas.
Communicates Effectively: Openly shares information with others and communicates in a clear and courteous manner.
Serves Others with Compassion: Invests time to understand the problems, needs of others and how to provide excellent service.
Solves Complex Problems: Seeks to understand issues, solves routine problems, and raises proper concerns to supervisors in a timely manner.
Offers Meaningful Advice and Support: Listens carefully to understand the issues and provides accurate information and support.
Performs Excellent Work: Checks work quality before delivery and asks relevant questions to meet quality standards.
Ensures Continuous Improvement: Shows eagerness to learn new knowledge, technologies, tools or systems and displays willingness to go above and beyond.
Fulfills Safety and Regulatory Requirements: Demonstrates basic knowledge of conditions that affect safety and reports unsafe conditions to the appropriate person or department.
Demonstrates Accountability: Takes responsibility for completing assigned activities and thinks beyond standard approaches to provide high-quality work/service.
Stewards Organizational Resources: Displays understanding of how personal actions will impact departmental resources.
Makes Data Driven Decisions: Uses accurate information and good decision making to consistently achieve results on time and without error.
Generates New Ideas: Willingly proposes/accepts ideas or initiatives that will impact day-to-day operations by offering suggestions to enhance them.
Applies Technology: Absorbs new technology quickly; understands when to utilize the appropriate tools and procedures to ensure proper course of action.
Adapts to Change: Embraces changes by keeping an open mind to changing plans and incorporates change instructions into own area of work.

Responsibilities

With assistance, prepare and process new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
Prepare and maintain documents required to be maintained and available internally and for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial
Participate in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
Procure equipment and supplies needed to fulfill project requirements
Record 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
Attend to query resolution in a timely manner
Assure research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice
Perform packaging and ship study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
With direction assist 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, develop and manage study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance
Serve 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
Participate in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements
With guidance, assess and evaluate potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation
Engage in open and positive communication with study participants and coworkers
With direction, perform or instruct 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 report 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