Full-Time

Clinical Translational Research Coordinator III

Hybrid/Onsite

Confirmed live in the last 24 hours

Vanderbilt Health

Vanderbilt Health

10,001+ employees

Healthcare

Mid, Senior

Nashville, TN, USA

Hybrid/Onsite position in Nashville, TN.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary

You match the following Vanderbilt Health's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • Demonstrates understanding and application of the federal regulations governing human subjects in research (i.e. 45 CFR 46, 21 CFR 50, 56, 312, 812, ICH GCP, and HIPAA)
  • Provide regulatory oversight and management of human subject clinical trials for the entire project period to ensure compliance with all applicable regulations, policies and procedures
  • Serve as primary regulatory contact with the sponsoring agency for regulatory approvals
  • Evaluate the protocol and sponsor documents and determine if additional items are needed for IRB/Sponsor approval
  • Develop site specific regulatory and other essential documents in compliance with the protocol and federal/local and institutional requirements
  • Prepare consent and HIPAA documents with appropriate language for industry sponsor, facility, and IRB approval
  • Complete the IRB submission, prepare IRB modifications based on analysis of contingencies presented by the committee or the study team, process sponsor requested changes and modify regulatory documents accordingly
  • Manage essential documents in accordance with the sponsor, IRB and federal government requirements
  • Submit amendment and continuing review data, investigate study irregularities and guide staff in reporting and documentation of events
  • Submit studies for closure and resolve any outstanding relevant findings with the sponsor and/or study team
  • Participate in study planning meetings, site initiation visits, monitoring visits and audits conducted by clinical trial sponsors, FDA, and IRB.
Responsibilities
  • 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.
  • Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures.
  • Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required).
  • 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.
  • Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.
  • Attends to query resolution in a timely manner.
  • Participates in the development of data collection tools.
  • Receives and tracks receipt and status of study specimens from multiple sites.
  • 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.
  • Responsible for study completion processes including data lock, study closeout, reporting 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 and assuring archival of appropriate/required documentation.
  • With department administration, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to 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 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.
  • Assesses for and implements process improvement initiatives within a clinical/translational trial and a department to assure research quality, and expedient completion of recruitment, timely receipt of research related payments and cost savings and expedient study reporting.
  • Defines and uses metrics to drive performance improvement. Shares metrics with investigators and administrators to demonstrate areas in need of improvement and tracks metrics to demonstrate effectiveness of improved processes.

Company Stage

N/A

Total Funding

N/A

Headquarters

Nashville, Tennessee

Founded

1875

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What believers are saying

  • Telehealth expansion can increase Vanderbilt Health's patient reach and service efficiency.
  • AI in radiology can improve diagnostic accuracy and operational efficiency at Vanderbilt Health.
  • Wearable health technology integration can enhance real-time patient monitoring and care.

What critics are saying

  • Rapid facility expansion may strain Vanderbilt Health's resources and operational efficiency.
  • Epic EHR implementation could face data integration and user adoption challenges.
  • Leadership transition at Vanderbilt University Hospital may impact ongoing projects and morale.

What makes Vanderbilt Health unique

  • Vanderbilt Health leads in transplant science with a new dedicated center.
  • Epic EHR Software enhances interoperability with Vanderbilt University Medical Center.
  • Vanderbilt Health's multisite trial for Rett syndrome is backed by a $13M grant.

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Benefits

Health Insurance

Dental Insurance

401(k) Retirement Plan

Paid Vacation

Professional Development Budget