Clinical Trials Associate 2

Vanderbilt University Medical Center

Posted 3 months ago

Full Time

Nashville, Tennessee

In Person

Smart Summary

Responsibilities

Coordinates the collection, interpretation, and documentation of data for clinical trials while ensuring adherence to protocols and regulations. Responsibilities include recruiting subjects, managing IRB documents, and processing lab specimens.

Qualifications

You have experience in clinical research support, including patient consent, IRB documentation, and specimen processing. You are adept at abstracting and documenting patient data, maintaining regulatory standards, and potentially mentoring new staff. A fundamental awareness of research administration and medical records management is expected.

Must Have Skills for ATS

IRB

IRB and regulatory documents

clinical trials

patient consent

case report forms

electronic data collection system

adverse reactions

Research Administration

Medical Records Management

Laboratory Practices

Job Description

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. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. 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 that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Organization:

Pediatric Psychology

Job Summary:

JOB SUMMARY
Performs a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials with occasional guidance. Assists in ensuring adherence to protocols, appropriate regulations, and deadlines.

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KEY RESPONSIBILITIES

• Coordinate protocol and patient consent form process

• Coordinates preparation of all IRB and regulatory documents; under direction of PI may draft various communications with Sponsor.

• Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary.

• Processes and ships lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards.

• Abstracts and records all patient data essential to the study onto required case report forms or into the electronic data collection system.

• Collects and monitors all study patient records to document treatments and outcomes as required by the protocol.

• Report all adverse reactions according to VU and protocol guidelines.

• Institutes process improvement measures for efficiency and productivity within the dept.

• Mentors new staff to perform job duties at an acceptable level and understand new processes and regulations. Encourages new employees to ask questions to spur process improvement.

• The responsibilities listed are a general overview of the position and additional duties may be assigned.

TECHNICAL CAPABILITIES

• Research Administration (Fundamental Awareness): Knowledgeable on all phases in the lifecycle of a sponsored research project. Well versed in and able to assist researchers in reducing compliance risks and assisting in routine and specialized processes.

• Medical Records Management (Fundamental Awareness): Knowledge of how and where to store and maintain basic records associated with job assignments.

• Laboratory Practices (Fundamental Awareness): Has limited experience, training, direct exposure, or past experience working with laboratory practices.

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: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area. Team Interaction: Provides informal guidance and support to team members.

    Core Capabilities :

    Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.

    Position Qualifications:

    Responsibilities:

    Certifications :

    Work Experience :

    Relevant Work Experience

    Experience Level :

    Less than 1 year

    Education :

    Associate's

    This role offers the opportunity to make a meaningful impact within Vanderbilt Health, supported by a comprehensive benefits package which may include health, disability, retirement and/or wellness offerings to enhance your well-being and professional growth.

    Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity.  EOE/Vets/Disabled.

    Vanderbilt University Medical Center

    From specializing in transplants and pediatric cancer to solving undiagnosed diseases, we know solving the most complex problems prepares us to solve any problem. We are committed to excellence in patient care, research, and medical education and training. We thrive on challenges, embrace collaboration and champion innovation. We are a growing academic health system with seven hospitals and hundreds of clinics throughout the Mid-South, as well as one of the nation's top biomedical research programs. Join us: https://www.vumc.org/careers/ We are regularly ranked among the nation's leading hospitals in terms of quality and effectiveness. Our tireless pursuit of personalized care has earned scores of patient satisfaction awards. Our research is expanding the frontiers of medical knowledge, and every day we advance toward a better understanding of human health. We blend new discoveries and technology into health education, preparing distinguished medical professionals to offer the most advanced and compassionate care possible. We set the pace for health care in the Southeast, and we are a nationally respected referral center. We are building on nearly 150 years of accomplishments to shape the future of health care the world over. For information about our clinical services for adults throughout the Vanderbilt Health system, visit http://www.VanderbiltHealth.com. For information about our comprehensive Monroe Carell Jr. Children's Hospital at Vanderbilt, visit https://childrenshospitalvanderbilt.org/ Social Media Participation Guidelines: http://VUMC.org/main/social
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