Clinical Research Coordinator II

Job ID
23890
Type
Regular Full-Time
Location
US-WA-Seattle
Category
Clinical Research Support Services

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 I/II will participate in the planning, coordination, and implementation of investigator-initiated and industry-sponsored clinical research studies for hematopoietic cell transplantation and cancer patients, with a focus on lung graft-versus-host disease and infections in the immunocompromised host. Studies involve longitudinal assessment of lung function and respiratory virus surveillance.

 

A successful candidate will be responsible for Institutional Review Board 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, and institutional review board documentation.  Responsible for the long-term follow-up activities associated with these protocols.  Assist with coordination of multi-site studies and serve as a resource to other investigative trial sites to accomplish study goals.

 

Applicants must include a cover letter to be considered.

Responsibilities

This individual will work under the supervision of the Principal Investigator, will report regularly to the PI on study progress, and will be required to perform his/her 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 FHCC/UW system including the Pulmonary Consult Service and the Blood and Marrow Transplant Service. 

 

DUTIES BY CATEGORY

  1. 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.
  • Screen and review study candidates’ medical records for study eligibility.
  • Assist the Principal Investigator (PI) with protocol development, revision, and data coordination and study analysis.
  1. Protocol Implementation
  • 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 tests, 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.
  1. Enrollment
  • Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained. Enrollment will include patient training of handheld home spirometry and other home-based study procedures.
  1. Education
  • Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
  1. Budget & Billing
  • Understand clinical trial budget and billing plans for patients enrolled on clinical trials.
  • 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.
  1. 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 procedure adherence with patients.
  • Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies. 
  • Maintain or assist in maintaining IRB correspondence and regulatory documentation.  Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, and other study reports.
  • Maintain appropriate source documentation, and complete or assist with accurate data entry into case report forms in a timely manner. 
  • Coordinate monitoring visits and respond to queries and other requests from study monitors.
  • Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
  • Travel for industry sponsored investigator meetings.
  • Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.

Qualifications

  • Bachelor’s degree in life sciences required.
  • Applicant must have a minimum of one to two years of clinical research or related experience.
  • Previous experience in clinical research and clinical data collection is preferred.
  • This position requires excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment. Must be flexiable and able to work well within a team; collaborative focus is essential.
  • Must have strong written and verbal communication skills, including computer skills.

 

 

This position is patient facing and/or requires access to Fred Hutch clinical facilities. As such, full COVID-19 vaccination is required as a condition of employment, without exception. Booster doses are strongly recommended but not required. If declining a booster, completion of the COVID-19 Vaccination Status Form Questionnaire and COVID-19 Booster Declination Training is required. Because of our immunocompromised patient population, there are no medical or religious accommodations available for any employee who is patient facing and/or requires access to Fred Hutch clinical facilities. Only employees whose positions are fully remote, who are not patient facing and/or require no access to clinical facilities, may apply for medical or religious accommodations. As a condition of employment, newly hired employees must provide proof of vaccination before their first day of employment.

 

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.

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 our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.

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