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.

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 Cdministration: 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

• 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
• Procures equipment and supplies needed to fulfill project requirements
• 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
• 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 the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants
• 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
• With direction, performs or instructs 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 reports 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
• 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
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. With guidance, assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation. Engages in open and positive communication with study participants and coworkers
• The responsibilities listed are a general overview of the position and additional duties may be assigned.
• With supervision, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance
• 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

Technical Capabilities

• Project Coordination (Fundamental Awareness): 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.
• Study Design & Conduct (Fundamental Awareness): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
• Clinical Research (Fundamental Awareness): 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.
• Communication (Fundamental Awareness): Clearly, effectively and respectfully communicates to employees or customers.

Our Academic Enterprise is one of the nation’s longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.

World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.

Aligning with Vanderbilt Health’s Strategic Directions, the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.

Core Accountabilities:

Organizational Impact: Delivers job responsibilities that impact own job area/team with some guidance. Problem Solving/ Complexity of work: Uses existing procedures, research and analysis to solve standard job related problems that may require some judgement. Breadth of Knowledge: Requires subject matter knowledge within a professional area to meet job requirements. Team Interaction: Individually contributes to project/ work teams.

Core Capabilities :

Supporting Colleagues: - 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. Delivering Excellent Services: - 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. Ensuring High Quality: - 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. Managing Resources Effectively :- 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. Fostering Innovation: - 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.

Position Qualifications:

Responsibilities:

Certifications :

Work Experience :

Relevant Work Experience

Experience Level :

Less than 1 year

Education :

Bachelor's

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled