Description

The Clinical Research Coordinator will conduct all aspects of the clinical trial, including regulatory tasks, under the direct supervision of the Physician. The Clinical Research Coodinator provides operational and administrative support in the management of patients accrued to multiple research protocols to assure subject’s safety and regulatory compliance. The Clinical Research Coodinator is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, and all applicable regulations and guidelines and ensuring effective data flow associated with research protocols.

The following experience is highly preferred:

-Experience with FDA trials, whether pharmaceuticals or devices but would love IDE trials

-Experience with billing/contracts/budgets for projects

-Interaction with study sponsors including industry and FDA

-Face to face interactions with patients whether for recruitment or followup

-Experience with GCP (Good Clinical Practice); CTMS

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Screens patients for Inclusion/Exclusion Criteria and communicates with the physicians regarding the patient’s participation Screens patients for Inclusion/Exclusion Criteria and communicates with the physicians regarding the patient’s participation Reads the protocol and develops source documents according to the protocol flow chart Performs any lab procedures required for the clinical trial(s) Able to take at least 5 trials, based on the complexity Follows Informed Consent Document guidelines for consenting subjects Accountable for Investigational Product (IP). Assures proper storage of IP according to the protocol. Instructs the patients on the how to take the IP and to bring all IP back to the site at each visit. Allows the patient to verbalize understanding of the instructions. Patients are instructed to bring back even the empty containers of IP. Maintain Study Specific Drug accountability Logs (as applicable) Maintaining all study specific Logs

Qualifications

EDUCATION / EXPERIENCE 

Include minimum education, technical training, and/or experience required to perform the job. 

Bachelor’s Degree in Science, Healthcare or a related field required At least three years of experience as a clinical research coordinator Knowledge of medical terminology Self-motivated and possess excellent communication skills with strong attention to detail Excellent customer service, organizational, problem solving and time management skills are essential Proficiency in a windows environment with a working knowledge of Word, Outlook, PowerPoint, Excel, and the Internet is required Willingness to be flexible and adaptable in a complex, matrix environment

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