Research Coordinator 2 - Department of Medicine, Division of Metabolism, Endocrinology and Nutrition

University of Washington Medical Center•Seattle, WA

1d•$65,352 - $96,000•Onsite

About The Position

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

Requirements

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.
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

Nice To Haves

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.

Responsibilities

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
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).
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
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