Job Description

The Department of Medicine, Division of Metabolism, Endocrinology and Nutrition, has an outstanding opportunity for a Research Coordinator 2 to join their team.

About this Opportunity

Reporting to the Research Coordinator Supervisor, the Research Coordinator 2 is responsible for study coordination, management of room/lab space and inventory, equipment calibration and maintenance, specimen storage, scheduling and communication with current and prospective study teams, and study intake activities such as feasibility assessments, resource allocation, and cost estimates. Additional responsibilities include monthly invoicing, ongoing liaison between study teams, nurses and CRU staff, and delivery of specialized services such as DXA scans and lab processing. The Clinical Research Unit (CRU) is currently supporting over 40 clinical research studies at various stages of progression.

Key Responsibilities

Research Study Management - 50%

• Coordinate the operations of clinical, biomedical, and/or behavioral research studies involving human subjects
• Coordinate specialized tasks with the research team such as the operation of equipment, processing of laboratory specimens, administering of treatment and/or medication in accordance with research protocol, assessment of patient reaction to medications and/or treatments as part of a research protocol and identification of potential adverse reactions
• Perform certain non-invasive patient-oriented procedures (including but not limited to EKG, DXA scan)
• Responsible for the processing and shipping of study-specific laboratory specimens
• Coordinate physician examinations and study protocol for technicians
• Assist in planning aspects of team research
• Directs study record keeping and data collection processes, ensuring data accuracy, integrity, and quality control
• Keep study files in compliance with Food and Drug Administration's regulations
• Read, interpret and communicate protocol for clinical studies providing data on the safety and efficacy of new drugs
• Establish and maintain effective working relationships with patients and their families, professional or community groups and volunteers
• Maintain contact with Principal Investigators, Co-Investigators, and public agencies which are involved with aspects of the research

Research Data Management - 20%

• Maintain records of study data.
• Design data collection tools.
• Obtain and record research data in conjunction with physician and other professionals on the research team.
• Assist in preparing interim reports for Principal Investigators, Study Sponsor and Human Subjects Review Board to ensure that each project timeline is being met.
• Communicate with Principal Investigators, pharmaceutical and equipment company medical personnel in handling results of studies (progress reports, case report forms).

Patient/Participant Management - 20%

• Screen, recruit and interview potential subjects to determine eligibility according to specific study protocols
• Obtain informed consent
• Enroll patients in research protocol
• Explain research protocol to participants
• Respond to patient inquiries regarding protocol
• Schedule patient participation
• Coordinate all aspects of the patient's care
• Ensure compliance with research protocol
• Inform referring physicians of protocol requirements
• Perform other duties as required

General CRU operations- 10%

• Manages maintenance of equipment and supplies
• Develops and provides cost estimates for investigators utilizing CRU services
• Collaborates with investigators, new investigators, and the CRU Director to obtain regulatory approval for industry sponsored and federally funded research

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

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

• Bachelor's degree in Science or Health related field and two years of relevant experience.
• Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Additional Qualifications

• Experience in research compliance
• Sound knowledge of IRB submission procedures, FDA, GCP, and NIH requirements relating to research involving human subjects
• Prior working experience with common eCRF systems (e.g., Inform, Medidata, Medrio, etc.)
• Knowledge of OnCore CTMS software
• Strong computer skills and competency with Microsoft Office software
• Strong attention to detail and ability to multi-task, organize and prioritize multiple projects
• Experience in clinical trial processes and implementation of research protocols
• Demonstrated ability to work independently with minimal supervision
• Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues and study sponsor representatives
• Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire

Preferred Qualifications

• Experience or knowledge working in a clinical setting.
• 3 plus years of experience in research compliance.
• Certification in Good Clinical Practice.
• Human subjects ethics training.
• DMID source document and regulatory document training, HIPAA and other clinical research training.
• Experience with EPIC/ORCA/MINDSCAPE/MAX/LIS record systems.

Working Conditions

• Office and participant visit location in the UW Diabetes Institute F Building.
• May require climbing stairs to access office location.
• Must have flexibility to meet programmatic needs by adjusting work schedule

Compensation, Benefits and Position Details

Pay Range Minimum:
$65,352.00 annual
Pay Range Maximum:
$96,000.00 annual
Other Compensation:

Benefits:
For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/
Shift:
First Shift (United States of America)
Temporary or Regular?
This is a regular position
FTE (Full-Time Equivalent):
100.00%
Union/Bargaining Unit:
UAW Research