Clinical Research Coordinator I/II

Details

Posted: 03-Mar-24

Location: Seattle, Washington

Type: Full-time

Salary: Open

Categories:

Staff/Administrative

Internal Number: 27155

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Clinical Research Coordinator (CRC) will participate in the planning, coordination, and implementation of investigator-initiated clinical research studies for oncology and palliative care studies.

Responsible for Investigational New Drug (IND) submissions, Institutional Review Board submissions and documentation, screening patients for eligibility, tracking patient visits, coordinating clinic procedures, and the collection, abstracting, reporting, and quality control of clinical trial data in accordance with protocols subject to FDA oversight. Responsible for coordination of studies and the long-term follow-up activities associated with these protocols.

Applicants must include a cover letter to be considered.

Responsibilities

This individual will work under the supervision of the Principal Investigator(s), will report regularly to the PI on study progress, and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. Uses judgment in data collection, quality control, liaison, and research coordination activities. Interacts with patients, physicians, and other clinical providers and support staff within and outside of the Fred Hutch/University of Washington system. The ability to work across Fred Hutch and University of Washington will be critical.

The ideal candidate will be able to address the full set of responsibilities in this listing and commit to a 1.0 FTE position. This role will have the opportunity to work partially at our campus and remotely.

DUTIES BY CATEGORY

Principal Investigator Support:

• Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy
• Assist the Principal Investigator (PI) with protocol and other study material development and revision and aid in statistical analysis

Recruitment and Enrollment:

• Liaise with Fred Hutch clinical and administrative teams to identify appropriate and effective recruitment pathways
• Review study candidates' medical records for study eligibility
• Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained

Education:

• Educate clinical teams, co-investigators, ancillary departments, and patients to ensure safe and accurate protocol implementation
• Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies

Protocol Implementation:

• Because the nature of the clinical study may vary within this job, the CRC must be capable of moving seamlessly between different protocols
• Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the clinical trial
• Initiate scheduling of patient clinic visits, and on-going study visits. Ensure clinical procedures, lab test, and other protocol specific activities are completed as outlined in the protocols
• Complete requisition forms, assemble kits for upcoming research visits, transport laboratory samples, and ensure samples are processed and shipped according to study specific guidelines, while tracking and maintaining research supplies
• Conduct chart review, study interviews and participate in focus groups
• Maintain appropriate source documentation, and complete or assist with accurate data entry into case report forms in a timely manner.
• Administer study questionnaires and disperse study-related payments

Regulatory:

• Maintain or assist in maintaining IRB correspondence and regulatory documentation. Prepare or assist in preparing consent forms, continuation review reports, protocol submissions and modifications, and other study reports
• Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy

Budget & Billing:

• Understand clinical trial budget and billing plans for patients enrolled on clinical trials or studies
• Work with internal partners to obtain and submit budget and billing information
• Participate in the review of charges for patients on clinical trials to ensure billing compliance

Other Duties Which May Be Required:

• Collaborate with Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study subjects
• Ensure study drug self-administration and accountability with patients
• Perform non-clinical ECGs
• Coordinate monitoring visits and respond to queries and other requests from study monitors
• Travel for industry sponsored investigator meetings or conferences as requested by the PI
• Maintain thorough knowledge in the field through related project meetings and symposia, reading related literature and maintaining professional associations
• Other duties as assigned

Qualifications

MINIMUM QUALIFICATIONS:

Clinical Research Coordinator I:

• • High school diploma, or equivalent
  • Applicant must have one to two years of research or related experience
  • Organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment
  • Excellent written and oral communication skills, leadership ability, and the flexibility to work in collaboration with multi-disciplinary teams
  • Computer experience including electronic CRF, MS Office including Excel, Outlook, PowerPoint and Access

Clinical Research Coordinator II:

All qualifications of Clinical Research Coordinator I, plus:

• • Minimum two to three years' experience in a clinical research or cancer registry environment with regulatory or human research protections.
  • Knowledge of clinical trials records, procedures, and computerized data processing systems.
  • Demonstrated knowledge of how to synthesize study conduct.

PREFERRED QUALIFICATIONS:

• Associate's or Bachelor's degree
• Experience in conducting interventional clinical trials (investigator-initiated or industry-sponsored) is desired at Clinical Research Coordinator I level
• Previous experience in oncology research and clinical data collection
• Previous experience in biobehavioral intervention studies, survey research, qualitative interviewing and chart review is preferred
• Knowledge of or prior experience with palliative or end of life care (or willingness to learn about this), including Medical Aid in Dying/Death with Dignity is preferred
• Knowledge using REDCap databases is desirable
• Desired Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

CRC I: The hourly pay range for this position is from $25.71 to $36.60 and pay offered will be based on experience and qualifications. CRC II: The hourly pay range for this position is from $30.30 to $45.43 and pay offered will be based on experience and qualifications. Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).

Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at [email protected] or by calling 206-667-4700.