Clin/Tran Research Coord IV, Pediatric Cardiology

Vanderbilt University Medical Center•Nashville, TN

1d•Onsite

About The Position

Provides leadership in coordinating the approval processes and conducting 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. This role serves as a role model, mentor, supervisor and consultant across teams and departments to provide expertise and share knowledge. Responsible for training and onboarding new and existing staff within the department and facilitates study and project related team meetings. The individual will understand, implement, and follow a clinical/translational study protocol and be able to conduct multiple studies independently. They will be able to identify when training is needed to safely and accurately perform or assess required procedures and prepare, provide, and/or participate in needed training. Problem-solving is a key aspect of this role. The position assists in identifying eligibility criteria for a protocol and assessing feasibility of recruiting and enrolling adequate populations locally and at participating sites. Monitors recruitment across projects, implementing process improvement to assure projects are completed in a timely manner. 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. Assists in determining data variables, in designing data dictionaries, and in developing data collection tools and databases and quality assurance processes. Oversees the management of research samples, receiving and tracking 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. Develops study specific standard operating procedures and tracking tools for specimen processing and handling. Develops systems and procedures for the processing and management of research samples. Ensures that all program staff have completed appropriate training as required. Digests complex clinical/translational information to determine if documentation is accurate and complete. Understands standard of care versus research and its application in billing compliance. Participates in budget and contract negotiation and facilitates interactions between sponsors and institutional departments. Responsible for project completion processes including timely study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing periodic quality 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. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Independently manages operational issues for large single and multi-center clinical/translational trials, including interacting with participating sites in the management of coordinating center activities, training, budget and invoicing, reporting to investigators, department administration and funding agencies. Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, representatives of professional organizations, participant advocates, and members of 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. Defines and uses metrics to drive performance improvement. Shares metrics with investigators and superiors to demonstrate areas in need of improvement and track metrics to demonstrate effectiveness of improved processes. The responsibilities listed are a general overview of the position and additional duties may be assigned.

Requirements

Certified Clinical Research Coordinator - Certification - Others
Certified Clinical Research Professional - Society of Clinical Research Associates (SOCRA)
LIC-Licensed Discipline Specific - Licensure-Others
Relevant Work Experience
Bachelor's degree
5 years of experience

Nice To Haves

Communication (Advanced)
Project Coordination (Advanced)
Study Design & Conduct (Advanced)
Clinical Research (Advanced)
People Management (Intermediate)

Responsibilities

Provides leadership in coordinating the approval processes and conducting research protocols.
Serves as a role model, mentor, supervisor and consultant across teams and departments to provide expertise and share knowledge.
Responsible for training and onboarding new and existing staff within the department and facilitates study and project related team meetings.
Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently.
Assists in identifying eligibility criteria for a protocol and assessing feasibility of recruiting and enrolling adequate populations locally and at participating sites.
Monitors recruitment across projects, implementing process improvement to assure projects are completed in a timely manner.
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.
Assists in determining data variables, in designing data dictionaries, and in developing data collection tools and databases and quality assurance processes.
Oversees the management of research samples.
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.
Develops study specific standard operating procedures and tracking tools for specimen processing and handling.
Develops systems and procedures for the processing and management of research samples.
Ensures that all program staff have completed appropriate training as required.
Digests complex clinical/translational information to determine if documentation is accurate and, complete.
Understands standard of care versus research and its application in billing compliance.
Participates in budget and contract negotiation and facilitates interactions between sponsors and institutional departments.
Responsible for project completion processes including timely study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data.
Performs periodic quality 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.
Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.
Independently manages operational issues for large single and multi-center clinical/translational trials, including interacting with participating sites in the management of coordinating center activities, training, budget and invoicing, reporting to investigators, department administration and funding agencies.
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, representatives of professional organizations, participant advocates, and members of 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.
Defines and uses metrics to drive performance improvement.
Shares metrics with investigators and superiors to demonstrate areas in need of improvement and track metrics to demonstrate effectiveness of improved processes.