Clinical Research Specialist

Community Health System•Fresno, CA

About The Position

We are looking for a Clinical Research Specialist to join our growing team! Working closely with the Principal Investigator, you will be responsible for clinical trials, including facilitating and coordinating daily study activities. In your role, you will consistently have the opportunity to lead our research efforts! You should possess the ability to carry out proper handling of highly sensitive information, all the while following protocol and maintaining IRB approval. From study testing, to enrollment of multicenter clinical trials, to longitudinal cohort studies, your expertise will be essential to the quality improvement of our research process.

Requirements

Bachelor's Degree in Healthcare or Health Sciences field required
1 years of research or clinical trial experience required
BLS - Current Basic Life Support (BLS) for Healthcare Providers by American Heart Association (AHA) required
One of the following is required within 1 year of hire or transfer into position CRA - Clinical Research Associate CCRP - Certified Clinical Research Professional

Nice To Haves

Master's Degree in Healthcare or Health Sciences field preferred
Experience working within UC Consortiums (StrokeNet, NIH, National Cancer Institute) is preferred.
Experience with specific rating scales such as MMSE, CDR, ADAS-Cog, CIBIC, CSSR-S (Suicide rating), Ham-D, NPI, RUD, Trails A and B, Geriatric Depression Scale, ADLs, DAD, and/or Wechsler Memory Scale is preferred.
Experience working within Neuroscience/Neurology or Oncology

Responsibilities

Participate in the development of accurate source material for training with other clinical departments as required.
Prepare and maintain all IRB documentation, including study applications, modifications, renewals, and study closures.
Provide accurate and timely data collection, documentation, entry and reporting to both sponsor and study specific databases.
Ensure site compliance with research protocols by reviewing regulatory requirements to confirm implementation of appropriate methods, practices and procedures for all research activities. Ensure compliance with federal, state, and hospital policies and/or procedures. Provide ongoing quality control audits, including maintaining ongoing investigational drug accountability.
Communicate and collaborate specific study requirements with the PI and other research teams, including internal and external parties, sponsors, monitors, and study participants.
Monitor patients for study eligibility and assist with the informed consent process from potential research participants. Identify and report issues that may affect the accuracy and quality of the study design.