Clinical Trials Associate 2

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Organization:

VICTR

Job Summary:

Clinical Trials Associate 2 – VICTR Center for Emergency Care Research and Innovation (CERI) Department

NOTE: This is a fully on-site position that will require weekend work and rotating holiday work.

JOB SUMMARY
In your pivotal role as a Clinical Trials Associate 2, you will be performing a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials with occasional guidance. You will be assisting in ensuring adherence to protocols, appropriate regulations, and deadlines.

About the Department:
The Vanderbilt Institute for Clinical & Translational Research (VICTR) is Vanderbilt’s virtual home for clinical and translational research. Supported by Vanderbilt University Medical Center’s Office of Research and the NIH-sponsored Clinical and Translational Service Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to patient care. VICTR functions to help researchers and clinicians do their jobs better by providing tools and support to improve the quality of research, publications, grant writing, and training for future doctors and researchers. For more information, please visit https://victr.vumc.org/.

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KEY RESPONSIBILITIES

• Coordinate protocol and patient consent form process and develop assessment tool per protocol to use in clinical research.

• 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.

• Check values from lab and rates toxicity levels.

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

• Trains and 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.

REQUIRED SKILLS

• Associate's Degree (or equivalent experience) (Required)

• 1 year experience (Required)

PREFERRED SKILLS

• Master’s Degree

• Prior clinical experience

• Excellent time-management skills

• Excellent interpersonal skills

• Excellent critical thinkin