Clinical Study Coordinator Jobs in Bothell, WA (NOW HIRING)

Job Description

The Division of Cardiology has an outstanding opportunity for a temporary Research Study Coordinator 1 to join their team.

About this Opportunity

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.

Key Responsibilities

Research projects are focused on, but not limited to, sleep and cardiovascular monitoring in healthy subjects, patients with sleep disorders, cardiovascular disease, and critical illness. The Research Study Coordinator will be responsible for the following:

I. Study subject enrollment and data collection: 50%

• 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.

II. Study protocol development and management: 30%

• 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.
• Assist with overseeing 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).

III. Administration: 20%

• 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.
• As many of these large trials utilize Core Laboratories for the sites to send the samples, the Research Coordinator must know how the Core Laboratories work, the procurement and shipment of samples and how to solve any problems related to these issues.
• Assist the PI with fiscal and budgetary administration.

REQUIRED QUALIFICATIONS

To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Minimum Qualifications

• 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.

Applicants who do not meet these qualifications WILL NOT be forwarded to the Hiring Manager.

Preferred Qualifications

• 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.

Compensation, Benefits and Position Details

Pay Range Minimum:

Pay Range Maximum:

Other Compensation:

Benefits:

Shift:

Temporary or Regular?

FTE (Full-Time Equivalent):

Union/Bargaining Unit:

About the UW

Working at the University of Washington provides a unique opportunity to change lives - on our campuses, in our state and around the world.

UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty.

Our Commitment

The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu.

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.