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Clinical Research Coordinator I

Clinical Research Coordinator I

Job ID 
10882
Type 
Regular Full-Time
Company 
Fred Hutchinson Cancer Research Center
Location 
US-WA-Seattle
Category 
Administrative Support

More information about this job

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Clinical Research Coordinator will facilitate the planning, coordination, and implementation of investigator-initiated and industry- sponsored clinical research studies involving human subjects. The incumbent will have daily interaction with faculty, study staff, pharmaceutical sponsors, physicians, other health care personnel, and patients as a representative of an active and growing hematological malignancy research program and will be expected to create and maintain cross-functional working relationships with internal teams and external partners.

Responsibilities

Under the supervision of the Clinical Trials Manager, this  positon will manage a portfolio of interventional oncology clinical protocols 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.

  • With minimal guidance, serve as designee of the Principal Investigator (PI) to manage the daily operations of assigned research studies that meet research objectives and ensure compliance with all aspects of Institutional, 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).
  • Review study candidates’ medical records for study eligibility.
  • Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained.
  • Educate clinical teams, ancillary departments, and patients to ensure safe and accurate 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 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.
  • Understand clinical trial budget and billing plans for patients enrolled on clinical trials, ensure procedures are ordered correctly for billing purposes and track billable services for accurate fiscal management.
  • Maintain appropriate source documentation, and complete 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.
  • 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.
  • Administer study questionnaires.
  • 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.
  • Participate in the review of charges for patients on clinical trials to ensure billing compliance.
  • Occasional evening and weekend travel to study meetings is required.
  • Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.
  • Other duties as assigned.

This position requires a flexible work schedule. Stringent deadlines from pharmaceutical companies for protocol implementation and data collection may require overtime. Integrating required elements of research into complex patient schedules (e.g collecting and processing multiple blood specimens for pharmacokinetic sampling) may also require occasional overtime, including evenings.

Qualifications

Minimum requirements:

  • Associates degree required.
  • Minimum of two to three years of clinical research or related experience required.
  • This position requires excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment. 
  • Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills. 
  • This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position 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.

Preferred requirements:

  • Bachelor’s degree preferred.
  • Previous experience in oncology research and clinical data collection is preferred. 

 

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, 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 escmail@fredhutch.org or by calling 206-667-4700.