Clinical Research Coordinator
$75k to $80k
ApplyClinical Research Coordinator
Posted 5 days ago
SENIORITY
Senior
SALARY
$75k to $80k
About the role
- Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
- Scheduling of patients for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following: changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Maintains accurate source documents related to all research procedures.
- Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
- Schedules and participates in monitoring and auditing activities.
- Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- May involve in assisting with patient research billing and reconciliation.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- May coordinate training and education of other personnel.
- May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
- Responsible to plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
- May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
- May identify new research opportunities and present to investigators
- Participates in required training and education programs.
- BA/BS Degree – Preferred.
- ACRP/SoCRA (or equivalent) certification preferred.1 year minimum of clinical research coordination experience, required
- Previous Oncology/Hematology experience preferred.
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