Clinical Research Coordinator II (Regulatory/Remote) - Medical Oncology

Washington University in St. Louis

17d

About The Position

Clinical research is a heavily regulated field. It is regulated at the federal level by the Department of Health and Human Services, Office of Human Research Protections, the Food and Drug Administration, the Office of Civil Rights, to name a few. There are state and local rules, regulations and statutes that may impact the conduct of clinical research. In addition, institutional policies from the University, School of Medicine and the Division also come into play. Position assists investigators as coordinator of a complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants; responsible for managing and recording all phases of study protocol as required by sponsoring agency to ensure compliance

Requirements

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
Basic Life Support - American Heart Association, Basic Life Support - American Red Cross
Clinical Research (2 Years)
Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements).
Basic Life Support certification must be obtained within one month of hire date.

Nice To Haves

Clinical Research
Clinical Study Protocols
Database Management
Research Projects
Spreadsheet Analysis
Statistical Analysis Software (SAS)

Responsibilities

Assists in developing plans for research projects and discusses the interpretation of results; collaborates in the preparation of manuscripts for publications and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
Coordinates the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
Evaluates and interprets collected clinical data as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
Performs other duties as assigned.

Benefits

Up to 22 days of vacation, 10 recognized holidays, and sick time.
Competitive health insurance packages with priority appointments and lower copays/coinsurance.
Take advantage of our free Metro transit U-Pass for eligible employees.
WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.
WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume