Clinical Trials Associate 2

Vanderbilt University Medical Center•Nashville, TN

About The Position

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.

Requirements

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.
Relevant Work Experience
Associate's degree

Nice To Haves

Less than 1 year of experience

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.