Clinical/Translational Research Coordinator I - Asthma Research

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Organization:

Allergy, Pulmonary and Critica

Job Summary:

JOB SUMMARY
Responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance with all policies, with some guidance.

The Center for Asthma Research (CAR) is an interdisciplinary research center at Vanderbilt University Medical Center comprised of highly collaborative and internationally recognized physicians, scientists and scholars dedicated to research, education and community involvement in pediatric and adult asthmas and allergic diseases.

The goals of the Center are to find prevention strategies, treatments and cures for asthma and allergic diseases, among the most common chronic diseases that impact both children and adults.

The Center has a bedside-to-bench translational approach that: focuses on casual risk factors for asthmas and allergic disease development, identities mechanism(s) of action, develops and tests primary, secondary and tertiary prevention strategies, innovates treatments, and trains the next generation of scientists.

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Specific Tasks and Skills Include But Are Not Limited To:  

Research Study Support: Assist with research participant screening, enrollment, data management, research reports, regulatory documentation, case report form development, participant compensation and auditing, working in a multidisciplinary team. 

Scientific Communication: Participate in marketing initiatives for the Center and assist in creating scientific content, editing, and maintaining website. Edit grant applications, manage and link references.

Research Administration: Manage/schedule meetings and calendar in an efficient and organized manner. Respond promptly and professionally to inquiries and emails. Plan visiting colleague itineraries and coordinate advisory board and investigator meetings. Manage PI professional domestic and international travel. Maintain, update, and edit investigator biosketches and CV.

Key Responsibilities
• 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
• Prepares and maintains 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. 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
• 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
• 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
• Serves as an advocate for human subjects by establishing and maintaining c