Clinical Research Coordinator - 247872

Job Summary

We are a growing integrated research organization dedicated to bringing innovative care to patients across the U.S. The CRC is responsible for the day-to-day operations of clinical trials at the site which include coordinating participant visits, recruiting and retaining trial participants, and performing tasks as delegated, required to complete a study according to the protocol and ICH-GCP guidelines.

Key Responsibilities

Under the direction of the Senior Director of Clinical Research and the Principal / Sub

Investigator(s) :

o Coordinates with Principal Investigator and local site to ensure that clinical research trials and activities are performed in accordance with the study protocol, FDA, GCP, ICH Guidelines and SOPs.

o Adhere to clinical trial protocols and coordinate and perform assigned clinical trial activities including, but not limited to :

o Participant pre-screening, recruitment and scheduling

o Complete protocol and trial system training

o Maintenance of regulatory documents

o Conducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study.

o Conducting participant visits

o Ability to perform basic lab and clinical procedures per protocol, such as :

o blood specimen collection (phlebotomy)

o blood pressure

o vitals

o EKGs

o centrifuge operation

o storing and shipping of lab specimens

o accountability of specimens and notification of courier for specimen pick-up

o Entering data in the EDC and resolving all queries

o Updating and maintaining trial logs and participant charts

o Conducting monitoring visits and resolving issues as needed in a timely manner

o Managing and reporting of AEs, SAEs, and deviations

o Maintains adequate inventory of study supplies

Qualifications

o College degree (health sciences) preferred or significant relevant experience

o At least 2 years of CRC experience in a direct patient care role

o Knowledge of Good Clinical Practice (GCP), IATA and FDA regulations pertaining to clinical trials

o Fluent in written and spoken English

o Ability to complete clinical procedures including phlebotomy, vitals, height, weight,

ECGs