Clinical Research Coordinator I - CardioVascular, Electrophysiology

Tufts Medicine•Boston, MA

19h•Onsite

About The Position

The CardioVascular Center (CVC) integrates the clinical services of Cardiology, Cardiac Surgery, Vascular Surgery, Interventional Radiology and Anesthesiology under a single, collaborative, inter-disciplinary organizational umbrella and it has an academic mission centered in its CardioVascular Center Research Institute (CVCRI). It offers a full range of primary-through-quaternary cardiovascular services, with over 3,300 cardiovascular hospital discharges and over 16,000 ambulatory visits annually. The CVC has the infrastructure needed to support its highly robust and productive clinical research efforts in vascular diseases, heart failure and transplant, mechanical circulatory support, interventional cardiology, cardiac arrhythmia, hypertrophic cardiomyopathy, cardiac imaging, cardiovascular surgery, and preventive cardiology. This position will support the research of Dr. Margaret Infeld. As a Clinical Research Coordinator, this role will manage clinical research projects funded by industry as well as investigator led trials. The candidate will be responsible for managing and assisting the Principal Investigator and research team in the coordination of all activities of studies as required for successful implementation of the study protocol(s) and interpretation of study findings. Job Overview This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned.

Requirements

Bachelor’s degree OR High School Diploma or equivalent AND Four (4) years of related experience.
Basic Life Support (BLS) certification may be required based on specific role requirements.

Nice To Haves

Two (2) years in research related activities.
IATA Hazardous Good Shipping certification.
CITI Human Research Protection certification.

Responsibilities

Assists in the recruitment of study participants.
Completes follow up with study participants in prescribed settings as required.
Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.
Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.
Assists with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review such as amendments, adverse event reporting and annual reviews.
Performs basic laboratory activities as needed.
Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.
Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.
Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
Participates in site visits with the study sponsor to review completeness and accuracy of study documentation.
Maintains inventory of all study supplies.
Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.
Reviews all eligibility and ineligibility criteria in the patient’s record.
Verifies information with the physician.
Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.
Conducts a QC check of completed CRFs prior to submission for data entry.
Coordinates resolution of all data queries.
Completes data entry as warranted.
Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.