Research Study Coordinator (Temporary)

University of Washington•Seattle, WA

2d•Onsite

About The Position

The Division of Cardiology has an outstanding opportunity for a temporary Research Study Coordinator 1 to join their team. Reporting to the PI/Manager, the Research Study Coordinator will assist the PI with research projects including protocol management, subject enrollment, communicating with sponsors, and other research related tasks. Under general supervision, coordinate the operations of research studies involving human subjects and requiring the application of knowledge and skills specific to the study. Coordinate, schedule, and monitor research activities and subject participation. Interpret and apply protocol; conduct interviews, administer tests, and record observations; coordinate the management of study data; monitor data to maintain quality control; summarize study results and prepare reports. This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position requires daily interaction with funding agencies including federal agencies, industry sponsors (pharmaceutical and device), physicians, and other healthcare personnel (nurses, patient care coordinators, etc.), and patients. Several projects may progress simultaneously with an expectation of additional projects in the future. This employee will closely work with the faculty PI, and students to help achieve the academic mission of the University.

Requirements

Two years of college level course work in a relevant academic area AND two years of experience performing work in support of clinical, biomedical, or behavioral research studies involving human subject.
Excellent communication and organizational ability.
Knowledgeable with IRB and other regulatory process of research.
Previous experience working directly with patients.
Basic office computer skills; MS office, prior use of database management program, experience with RedCap.
Comfortable with basic business writing.

Responsibilities

Identify potential subjects by chart screening, active solicitation via advertisement, and referrals.
Recruit, interview, and screen potential subjects and determine eligibility according to established criteria.
Obtain consents.
Collect data in a variety of settings such as institutions, clinical settings and/or subjects' homes.
Apply physiological monitoring devices under investigation to subjects in the hospital.
Interpret and record subject behaviors using observation codes, rating scales, questionnaires or standardized assessments.
Administer psychological/neuropsychological or other test batteries.
Record, retrieve, and download physiological data.
Extract technical, medical, and/or behavioral information from institution or clinical records.
Maintain adherence to research protocols and verify the accuracy of research study data.
Assist in the preparation of human subject applications, consent forms, and progress reports for the institutional review board.
Assist in modification of procedures for collecting and summarizing data.
Use statistical and database management programs to analyze data and prepare summary narrative reports, graphs, tables, charts and illustrations.
Assist in developing a computerized system for tracking study participants; monitor data quality control to ensure adherence to study protocol.
Produce enrollment/follow-up plans and communication tools to enable physicians to facilitate the study.
Conduct follow-up reviews with study participants including assessment of subject response to therapy and evaluation of adverse events; lab data review and identification of abnormal values; assessment and documentation of subject compliance with medications and visits.
Oversee the accuracy and completion of all regulatory documents, IRB documents, and signed informed consent forms.
Assess documentation of all adverse events, determine severity, and report events to PI and IRB.
Facilitate study site visits and ensure all required documentation is available for auditors and monitors.
Manage all activities related to a study qualification visit, initiation visit, and study closeouts.
Enter study data on paper or electronic case report forms (eCRF’s).
Assist in establishing and maintaining contact with community agencies, health care providers and/or study sponsors; inform sponsors of current status; refer participants to community service agencies as appropriate.
Perform other duties of a Research Study Assistant.
Undergo required Human Subjects Training and Good Clinical Practice (GCP) training; will help other volunteer researchers with the onboarding process.
Assisting PI with budgetary planning.
Manage procurement and shipment of samples to Core Laboratories and solve any problems related to these issues.
Assist the PI with fiscal and budgetary administration.