Vanderbilt University Medical Center
Clin/Trans Research Coordinator I
Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37247
Overview
Discover Vanderbilt University Medical Center: Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something bigger, take pride in their work, and strive for continuous improvement. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.
Overview - The Center
The Multiple Sclerosis Center at Vanderbilt University Medical Center evaluates and treats neuroimmunology patients with multiple sclerosis (MS). The team is seeking a motivated applicant with an interest in neurology research to join a multidisciplinary research team dedicated to finding a cure. This is an on-campus, full-time position with an estimated schedule of 9:00 – 5:00, Monday through Friday.
Responsibilities With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports in accordance with institutional and departmental policies, procedures, and federal regulations.
Prepares and maintains documents required for regulatory authorities and/or sponsors before, during, and after the conduct of a clinical/translational trial. Participates in periodic site visits to review research, source documentation, and procedures.
Procures equipment and supplies needed to fulfill project requirements.
Records data from source documentation and/or participant interaction onto case report forms (paper or electronic) with accuracy, completeness, and timeliness; attends to query resolution timely and ensures compliance with regulations and good clinical practice.
Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with guidelines and maintains appropriate documentation.
Assists with study completion, closeout, and archiving of study files; performs ongoing checks of data to ensure completeness and continuity.
Develops and manages study budgets with supervision, monitoring invoicing and maintaining clinical trial billing compliance.
Advocates for human subjects by maintaining communication with Investigators, research staff, Sponsors, participants, and professional organizations, and by monitoring trial processes and participant protections.
Assesses eligibility for study participation and ensures participants meet eligibility requirements; communicates with participants and coworkers regarding eligibility and participation.
Performs or instructs others in procedures described in the protocol, reporting any deviations and determining if amendments or safety reporting are required.
Performs other duties as assigned to support the research program.
Technical Capabilities Project Coordination (Fundamental Awareness): Experience coordinating or supporting projects, collecting project materials, status reports, metrics, and completion data.
Study Design & Conduct (Fundamental Awareness): Applies qualitative and quantitative methods to preparatory, regulatory, and analytic tasks within a study lifecycle.
Communication (Fundamental Awareness): Clear, effective, and respectful communication with colleagues and stakeholders.
Clinical Research (Fundamental Awareness): Accesses resources to accomplish the job; files and collates trial documentation; maintains and analyzes study documentation; demonstrates systematic problem solving.
Position Qualifications
Education : Bachelor’s degree. Experience : Less than 1 year of relevant work experience. Certifications : Not specified in this description. Other : Vanderbilt Health is committed to fostering an environment where everyone can thrive and upholds equal opportunity principles. EOE/Vets/Disabled.
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Discover Vanderbilt University Medical Center: Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something bigger, take pride in their work, and strive for continuous improvement. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.
Overview - The Center
The Multiple Sclerosis Center at Vanderbilt University Medical Center evaluates and treats neuroimmunology patients with multiple sclerosis (MS). The team is seeking a motivated applicant with an interest in neurology research to join a multidisciplinary research team dedicated to finding a cure. This is an on-campus, full-time position with an estimated schedule of 9:00 – 5:00, Monday through Friday.
Responsibilities With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports in accordance with institutional and departmental policies, procedures, and federal regulations.
Prepares and maintains documents required for regulatory authorities and/or sponsors before, during, and after the conduct of a clinical/translational trial. Participates in periodic site visits to review research, source documentation, and procedures.
Procures equipment and supplies needed to fulfill project requirements.
Records data from source documentation and/or participant interaction onto case report forms (paper or electronic) with accuracy, completeness, and timeliness; attends to query resolution timely and ensures compliance with regulations and good clinical practice.
Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with guidelines and maintains appropriate documentation.
Assists with study completion, closeout, and archiving of study files; performs ongoing checks of data to ensure completeness and continuity.
Develops and manages study budgets with supervision, monitoring invoicing and maintaining clinical trial billing compliance.
Advocates for human subjects by maintaining communication with Investigators, research staff, Sponsors, participants, and professional organizations, and by monitoring trial processes and participant protections.
Assesses eligibility for study participation and ensures participants meet eligibility requirements; communicates with participants and coworkers regarding eligibility and participation.
Performs or instructs others in procedures described in the protocol, reporting any deviations and determining if amendments or safety reporting are required.
Performs other duties as assigned to support the research program.
Technical Capabilities Project Coordination (Fundamental Awareness): Experience coordinating or supporting projects, collecting project materials, status reports, metrics, and completion data.
Study Design & Conduct (Fundamental Awareness): Applies qualitative and quantitative methods to preparatory, regulatory, and analytic tasks within a study lifecycle.
Communication (Fundamental Awareness): Clear, effective, and respectful communication with colleagues and stakeholders.
Clinical Research (Fundamental Awareness): Accesses resources to accomplish the job; files and collates trial documentation; maintains and analyzes study documentation; demonstrates systematic problem solving.
Position Qualifications
Education : Bachelor’s degree. Experience : Less than 1 year of relevant work experience. Certifications : Not specified in this description. Other : Vanderbilt Health is committed to fostering an environment where everyone can thrive and upholds equal opportunity principles. EOE/Vets/Disabled.
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