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Clinical Trial Coordinator

1 month ago

Bloomfield, United States Coda Staffing Full time
Job DescriptionJob Description

This position is on site Mon thru Fri in Bloomfield, NJ

MUST BE BILINGUAL ENGLISH/SPANISH

Job Description

Looking for a Bilingual Eng/Spanish Clinical Trial Coordinator.

The Clinical Trial Coordinator works with and under the direction of the Principal Investigator (PI) to oversee clinical trials.

Essential Functions:

Utilizing Good Clinical Practice, the LCRC ensures assigned studies are conducted in accordance with the protocol, Food and Drug Administration (FDA), HIPAA, the Office for Human Research Protections (OHRP), IRB and institutional Standard Operating Procedures:

· Demonstrates leadership in ensuring adherence to ethical practices during the conduct of research in order to protect the rights and well-being of patients and the collection of quality data

· Maintain adequate inventory of study supplies. Handle/dispense investigational drug and adhere to the sponsor’s protocol on Investigational Drug/Device Accountability. Monitor and maintain temperature logs. Provides patient teaching regarding administration, as necessary.

· Attend Investigator Meetings and training sessions as needed. Occasional travel (required).

· Supports the regulatory staff in maintenance of regulatory documents in accordance with Envision Ocular, LLC SOP and applicable regulations

· Other duties as assigned

Qualifications:

· Bachelor’s degree from a recognized college or university in science or health-related field.

· At minimum, two years of experience in a clinical research environment, strongly preferred (certification as a CCRC or CCRP is desired).

· At minimum, one-year supervisory experience

· Must speak Spanish; Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts

· Ophthalmology experience a plus

· Detailed-oriented and meticulous in all aspects of work

· Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative

· Ability to work independently as well as in a team environment

· Possess the ability to work well under pressure, multi-task and manage deadlines

· Proficiency in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire

Competitive pay (based upon experience) and benefits

 

PTO SICK BENEFITS 401K

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