What are the responsibilities and job description for the Clinical Research Coordinator position at Biomedical Research and Education Foundation of Southern Arizona?
The Biomedical Research and Education Foundation of Southern Arizona (BREFSA) is looking for a Clinical Research Study Coordinator. We are a non-profit corporation established to facilitate and support the medical research and educational mission of the Southern Arizona VA Health Care System (SAVAHCS). We promote biomedical and health service research for the benefit of Veteran patients.
Clinical Research Study Coordinator
Duties and Responsibilities:
Performs research activities as outlined in the protocol; implementing and organizing clinical research studies assigned to him/her which includes but is not limited to:
- Conducts clinical studies as outlined in the study protocol within the local and federal regulations and guidelines; adheres to good clinical practices.
- Works as part of a team focused on research where use of both written and verbal communication with research staff, clinical staff, patients and families is a daily necessity.
- Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed according to skill level and certifications.
- Collects and controls research data and subject information; and maintains accurate data collection of all study data.
- Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection.
- Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I.
- Enrollment of subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations. This also involves the ability to explain technical information so that it is understood by patients and their families.
- Adheres to departmental quality control guidelines.
- Ensures that the investigator verifies that the subject meets inclusion/exclusion criteria; verified that the subject and/or legal guardian has provided informed consent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
- Assists PI in education of other study personnel with regards to study responsibilities and keeps written documentation of this training.
- Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
- Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRFs are completed prior to monitoring visits.
- Responsible for regulatory/IRB submission and issues that arise after study has been initiated; maintains regulatory binders.
- Performs other duties and maintains schedule as required by a protocol or unit needs.
Required Qualifications
- A Minimum of 1-year experience as a Clinical Research Study Coordinator is required.
Preferred Qualifications
- Understanding of medical terminology and clinical trials.
- IRB/regulatory experience
- Experience interacting with sponsors/monitors
- Experience with CRFs/EDC, and GCP
- Excellent interpersonal skills and ability to interact with staff, patients and families.
- Working knowledge of PCs and word processing and data management software,
- Verbal and written communication,
- Goal-oriented; self-directed,
- Ability to actively participate as a team player.
Job Type: Full-time
Pay: $25.00 - $36.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Paid time off
- Retirement plan
- Vision insurance
Work Location: In person
Salary : $25 - $36