Clinical Research Coordinator - 247872
MedixWorcester, MA, United States- Full-time
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
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