Clinical Research Coordiantor I

Job ID
20704
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Clinical Research Support Services

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.

 

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

 

The Clinical Research Coordinator I (CRC) will coordinate day-to-day activities for assigned clinical research protocols and perform monitoring duties for a PI initiated multi-center clinical trial for the Infectious Disease Sciences Program while demonstrating competence in clinical research skills, problem-solving, and priority setting.

Responsibilities

Responsibilities:

The incumbent will participate in the planning, coordination, and implementation of complex investigator-initiated, industry-sponsored, and cooperative group clinical research studies involving human subjects in addition to performing monitoring duties for a multi-center clinical trial. This individual will work in a team of clinical research professionals under the supervision of and be trained in monitoring duties by the Senior Clinical Research Manager.  They will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. Collaborate with a multi-disciplinary team and provide guidance to other study staff in carrying out research implementation tasks.

 

Perform some or all the following responsibilities:

 

Study Conduct / Clinical Research Practice

  • Work independently in performing daily responsibilities required to plan and execute investigator driven/industry-based clinical research trials and non-intervention protocols.
  • Coordinate research and administrative activities related to studies, ensuring all projects are completed according to project timelines.
  • On assigned projects, act as the main protocol resource person for the investigator and/or research sponsor, research subjects, local and central labs, monitors, primary care teams, and investigational pharmacy staff.
  • Collaborate with investigators and coworkers to ensure completion of study activities
  • Train others as needed and develop standard operating procedures (SOP) or other necessary documents for standardized study conduct.
  • Screen and recruite subjects either within the consortium or the community dependent upon study specific requiremnts, enroll, and follow research subjects, complete case report forms (CRFs), place physician orders, coordinate research study visits, communicate with the primary care teams, investigational pharmacy staff and research subjects.
  • Travel to University of Medical Center, Seattle Children’s, and Seattle Cancer Care Alliance will be required for the enrollment of study subjects.
  • Ensure accurate enrollment records are maintained and up to date.
  • Coordinate specimen collection, transport, processing, storage, and shipment procedures according to protocol requirements. Track and maintain research supplies.
  • Create source documents or CRFs as needed to promote efficient data collection and entry.
  • Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
  • Identify and report any adverse events in accordance with protocol, regulatory guidelines, and institutional policy.

Study Monitoring Resposibilities:

  • Conduct monitoring for clinical trials to assure adherence to regulatory guidelines and regulations, and study protocol.
  • Verify the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures and drug dispensing accountability through review of CRFs/Medidata Rave/Vestigo, source documents, medical records, and regulatory documents.
  • Communicate to study staff all discrepancies noted and work with the study staff to assure that corrections and/or additions are made. Provide follow-up to ensure that corrective actions are successful.
  • Provide comprehensive monitoring visit reports as per the protocol.

 

 Protocol Development and Implementation

  • Help develop and review research protocols for feasibility and collaborate with study leadership to develop the study budget and implementation plans. 
  • 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.

Budget and Billing

  • Prepare requests for research prices on study activities and coordinate the research billing start-up process. 
  • Review, reconcile, and approve research study bills.  Work closely with the IDS fiscal staff to ensure accurate research billing and reimbursement.

Regulatory Compliance and Documentation

  • Facilitate protocol monitoring visits and collaborate with study monitors to resolve data discrepancies and procedural issues.
  • Provide input to the regulatory coordinator on protocol document submissions and continuing review reports.
  • Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, serious adverse event reports, and other study reports.

Other Duties Which May Be Required:

  • Perform retrospective chart review as required
  • Travel for investigator meetings and to study sites for monitoring
  • Will require weekends and holiday coverage for clinical studies. 
  • Other duties as assigned

Qualifications

Qualifications

  • BA/BS required in a biological or life science field. Master’s degree in healthcare related field preferred.
  • Minimum of one-year post-master’s or two years post-bachelor’s project coordination experience in clinical trials coordination setting. 
  • Computer experience including electronic CRF, EPIC, Medidata Rave, MS Office including Excel, Outlook, PowerPoint and Access. 
  • Knowledge using REDCap databases is desirable. 
  • Excellent written and communication skills, attention to detail, high-level organization, leadership ability, and the flexibility to work in collaboration with a multi-disciplinary team.
  • Desire Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification

 

In addition to job duties at Fred Hutch, this position also requires access to Seattle Cancer Care Alliance, which requires COVID-19 vaccination without exceptions.
Accordingly, as a condition of employment for this Fred Hutch position, 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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