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Tufts Medicine · 8 hours ago

Clinical Research Coordinator I - CardioVascular

Boston, MA

Full-time

Onsite

Mid Level

$45K/yr - $56K/yr

4+ years exp

Tufts Medicine is a healthcare organization seeking a Clinical Research Coordinator I to assist the Principal Investigator in planning and implementing clinical research studies. The role involves recruiting study participants, maintaining regulatory compliance, and performing basic laboratory activities.

Health CareHospitalMedical

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

Qualification

BLS certificationIATA certificationCITI certificationResearch experienceData collectionComputer skillsRecord-keepingOrganizational skillsAttention to detailCommunication skillsInterpersonal skills