Research Coordinator

Job Description

RESEARCH COORDINATOR

Req #: 233416 Department: DEPARTMENT OF MEDICINE: HEMATOLOGY AND ONCOLOGY Job Location: Seattle - Other Posting Date: 04/25/2024 Closing Info: Closes On 05/02/2024 Salary: $5,100 to $5,900 per month Other Compensation: Limited Recruitment: Open to UW Employees only
If you are a UW employee and would like to be considered for this position, please login to your UW employee profile to apply. Shift: First Shift Benefits: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills and dedication to build stronger minds and a healthier world.
UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty.
POSITION PURPOSE
The purpose of this position is to promote the research objectives of the Cancer Vaccine Institute (CVI) in the Division of Medical Oncology. This position works directly with clinical and laboratory-based faculty members who specialize in translational immunotherapy research targeting a variety of cancers. This position will work as a member of the Clinical Research Team that conducts primarily Phase I and Phase II Investigator-initiated clinical trials to test immune-based therapies for cancer.
Position Complexities:
Complexities and dimensions of this position include the requirement for close collaboration with research partners in community oncology practices to identify potential study patients, to interview patients to assess interest in clinical trial participation, and to review medical records to determine if patients are eligible for immunotherapy trials. Patients currently being enrolled in CVI trials typically have advanced stage cancer, and the emotional impact of working closely with this patient population can be a challenge. In addition, the position ensures that research activities meet all institutional, sponsor, and federal requirements. To implement investigator-initiated studies, this position will be well versed in all applicable Human Subjects Research regulations, HIPAA rules that protect patient privacy, and Good Clinical Practice guidance issued by the federal government. In addition, they will work closely with the CVI Immune Monitoring Lab, the UW Clinical Trials Office (CTO), the UW Institute for Translation Health Sciences, the Fred Hutch Cancer Center Consortium IRB and Clinical Research Support (CRS), and various UW clinical departments that provide research testing services. This position requires the collection and organization of a large volume of detailed medical and clinical research information, and the ability to continually refine processes and procedures to work more efficiently and effectively. Continuous process improvements are routinely written as formal clinical Standard Operating Procedures. This position must be able to work independently on multiple research projects with minimal written policies and procedures. This requires daily interaction with pharmaceutical sponsors, physicians, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 10 projects will be in progress simultaneously, with the expectation of additional projects in the future.
Position Dimensions and Impact to the University:
The UW Medicine CVI's mission is to conduct basic and clinical research that leads to the development of effective immune-based cancer therapies and diagnostic tests. The Research Coordinator will play a key role in implementing clinical trials that test new cancer therapies. They will be knowledgeable and observant of all applicable rules, regulations, and guidelines for the safe and ethical conduct of clinical research.
DUTIES AND RESPONSIBILITIES
Protocol Management - 40%

Ensure procedures meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA).

Develop, document, and maintain procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.

Assist in the design, creation and revision of research instruments (e.g. case report forms, AE logs, Study guides) as necessary to ensure quality data that satisfies research objectives.

Create and maintain complete source documentation for patients on assigned studies.

Participate in development of clinical protocols and consent documents.

Work with Regulatory Coordinator to ensure that reporting to the Institutional Review Board and study sponsors is timely, accurate and satisfies applicable regulation. Develop and implement corrective action plans to ensure protocol adherence and data integrity.

Assist in preparing and conducting sponsor monitoring visits.

Manage minimal risk protocols, including consenting patients for sample collection.

Assist with the maintenance of a manual for program-wide Standard Operating Procedures (SOPs) for clinical research.

Coordinate documentation and access for study monitors.
Patient Management – 30%

Implement research protocols at UWMC and FHCC, integrating research and clinical requirements to ensure patient safety and protocol compliance.

Communicate research requirements effectively with all providers involved in patient care including outside physicians who are interested in referring patients to CVI for clinical trials.

Conduct informed consent for potential patients involved in minimal risk studies.

Coordinate and assist with patients visits at the UW Medical Center with CVI clinical research staff.

Manage complex patient schedules.

Align research requirements and clinical care to ensure collection of accurate and reliable data.

Assist in ensuring patient safety while participating on a clinical trial by monitoring patients and interacting closely with the patient's clinical providers.

Maintain detailed records of patient contacts and medical records.

Maintain patient information in study management systems.

Verify research procedures for billing reconciliation purposes.

Coordinate long-term follow-up collection and tracking.

Independently obtain patient medical records, and develop a preliminary assessment of patient eligibility for Principal Investigator approval.

Explain logistical, clinical, and scientific aspects of clinical trials to potential study participants by telephone, e-mail, and/or in written documents.
Data Management - 30%

Retrieve data from patient charts and/or source documents, abstracts information from complex medical records and reports for entry into internal and sponsor provided case report forms/database. Case report form may be paper based or electronic. CRF completion and data entry responsibility may be shared with other team members, necessitating accurate and timely communication with all team members.

Prepare source data documents to collect/support all data associated with research protocols.

Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record said information into various study-specific data-capture systems (both electronic and paper-based).

Work professionally with sponsor representatives to review and resolve data and queries recorded in the case report forms. Exercise independent judgment on query resolutions.

Prepare and provide data for progress reporting and as requested by faculty, physicians or sponsors.
MINIMUM REQUIREMENTS

Bachelor's Degree in Science or Health-related field.

Minimum of 1-year experience in a research setting or data analysis and entry.

Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ADDITIONAL REQUIREMENTS

Excellent written and verbal communication skills.

Experience with Microsoft Office.

Organizational skills and attention to detail.

Ability to work well independently and as a member of a team.

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.
DESIRED QUALIFICATIONS

Previous experience working with oncology patients.

Previous experience conducting research in a hospital or academic setting.

Extensive knowledge of UW and/or FHCC policies, systems and procedures.

Experience in an academic or non-profit research environment.
CONDITIONS OF EMPLOYMENT

The Cancer Vaccine Institute is located at the UW Medicine at South Lake Union campus in a translational research environment that includes laboratory, clinical research and administrative office areas. This position requires some off-site travel to University of Washington Medical Center, Fred Hutch Cancer Center, Bloodworks Northwest. A shuttle is available.

Work is typically deadline driven and requires a high level of accuracy, extensive communication with staff and external collaborators from diverse backgrounds.

This position may require a flexible work schedule.

Stringent deadlines for protocol implementation, data collection, integrating required elements of research into complex patient schedules, and special event coordination may require occasional evening or weekend work.
Application Process: The application process may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are access ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.

Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.

The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or [email protected] .

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 .

Open to UW Employees only
If you are a UW employee and would like to be considered for this position, please login to your UW employee profile to apply.