Clinical Research Coordinator
Description
The position is responsible for, and critically important to the overall operational management of clinical research activities. Maybe responsible for coordination and help prepare protocols for study initiation; help design flowsheets, data forms, and source documents; gather and interpret laboratory data; may help recruit, enroll, register, schedule and retain study subjects; complete study forms to submit to sponsors and/or agencies; collect and enter data into databases, maintaining data quality; assist with preparation with reports and tables; attend team meetings.
Qualifications:
Prefer Certification from Society of Clinical Research Associates (SORCA) or Associate of Research Professionals (ACRP).
Minimally 1 year of research experience preferred. Including, significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.
BA or BS preferred.
Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, and implementing new strategies.
Knowledge of clinical research, clinical trials, protocols, FDA regulations, and complex visit structures.
Exceptional analytical skills to evaluate the importance and urgency of problems, excellent demonstrated interpersonal, verbal, and written communication skills.
Ability to analyze complex and non-routine issues requiring complex solutions.
Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skill in audit preparation, execution and follow up.
Excellent verbal and written communication and presentation skills. Excellent interpersonal skills to work in a diverse team.
Knowledge of EPIC and BEACON.
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