Clinical Research Coordinator II Job Hutchins Texas USA,Research/Development

Location: Hutchins

Summary

Clinical Research Coordinator 2 is a Part Time or Full Time Non-Exempt Position

Education and Experience Requirements:

Must be eligible to work in the U.S. and be a U.S. citizen
More than 4 years of research experience; or
3+ years of research experience and a Bachelor Degree in a relevant area; or
3+ years of research experience and an LVN; or
Greater than 1 year of research experience and a Masters Degree or Ph.D. in a relevant area
Nuclear Medicine and/or Oncology experience

SoCRA or ACRP Certification

Highly desirable and counts as one year of experience

Software Requirements

Experience with Microsoft Office and research database products

Responsibilities

The position of Coordinator 2 (“CRC2”) works under light supervision of the Principal Investigator or more experienced coordinator. The Coordinator 2 is responsible for conducting procedures for one or more research studies. The CRC2 may supervise less-experienced Coordinators or Research Assistants. They will maintain the protection of human subjects while meeting the research goals of each project. A Coordinator 2 will consistently exhibit behavior and communication skills that demonstrate DVARC’s commitment to superior customer service and dedication to the care of our veterans.

Supervisors

VANTHCS Principal Investigator, DVARC Director HR and Operations, works closely with Team Leader

Duties

In addition to the knowledge of the duties of an Assistant Coordinator and a Research Coordinator 1, a CRC2 may have the following duties:

Assists in the design of research survey forms to capture required participant information

Interviews study participants and/or family members to gather research information

Reviews exclusion/inclusion criteria with the Principal Investigator or Senior Coordinator to ensure subject eligibility

Conducts interviews to confirm study eligibility and willingness to follow and complete study procedures and visits

May perform consent process with patients, ensuring inclusion and exclusion criteria are met, taking responsibility for all aspects of research completeness, enrollment notes, administrative duties and data entry

Develops, coordinates and reviews research study procedures to ensure receipt, completeness and accuracy of study data

Coordinates, with the assistance of higher grade staff, all regulatory requirements such as preparing safety reports, adverse event paperwork, FDA compliance, sponsor monitoring and logs, laboratory standards, and maintenance of databases related to regulatory requirements

May assist with the study budget and negotiation of participant payments

Monitors budget, prepares reimbursement requests, approves expenditures and reconciles study accounts

Prepares and submits information in the Case Report Form and submits a billing matrix for funding source and submits to DVARC

Prepares statistical reports, charts and graphs as required

Assists in preparation of annual reports for federal, state, and local agencies

Informs IRB of amendments to research studies

Coordinates collection and data management of national research studies from multiple projects by interacting with internal and external research data managers, patients, and physicians for coordination of tissue samples, lab data and protocols, and other statistical information concerning research study subjects

Serves as primary liaison and prepares annual reports for federal, state, and/or local agencies.

Informs Institutional Review Board of amendments to research studies, and prepares protocols and detailed summaries in lay terms of any new research study

May provide full supervision to personnel of lower grades

May perform lower risk, less complicated procedures in studies, if directed by Principal Investigator

Must be able to do a study start up with the appropriate IRB and R&DC and safety committee.

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