• Assistant Clinical Research Manager - Center for Patient Derived Models

    Location US-MA-Boston
    Job Posted Date 2 weeks ago(5/8/2018 11:09 AM)
    Job ID
    2018-10773
    Category
    Clinical Research
    Type
    full time
    Grade
    21
  • Overview

    Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

     

    The newly created DFCI Center for Patient Derived Models (CPDM) seeking to fill an innovative position of Assistant Clinical Research Manager to support the Center in its collaborative research with Investigators in the DFCI and externally within other collaborators in industry and academics. The position will be supervised by Dr. Keith Ligon, CPDM Director, and the CPDM Associate Director. The candidate will be required to facilitate tissue-based research studies with client investigators of the CPDM and manage and professionally advise investigators on how to achieve specific requirements of model generation from patients with cancer. The position will provide applicants with outstanding opportunities for interaction with research scientists, physicians, clinical research staff, patients and biomarker research in a dynamic and exciting environment. The projects of client investigators will span research from basic science of patient derived models to integration of patient models into clinical trials of novel treatment approaches. This position involves managerial responsibilities. Prior managerial experience in related fields is preferred.

    Responsibilities

    • Identifies operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
    • Oversees processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate. Oversees regulatory process for related studies. Collaborates with the Office for Human Research Studies (OHRS)l, the Quality Assurance for Clinical Trials (QACT), and the Clinical Trials Office (CTO) to fulfill federal requirements governing human clinical trials. Completes all annual review requirements.
    • Collaborates with the DFCI QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control.
    • Oversees study enrollments and appropriate protocol treatment and follow-up care for patients in clinical trials.
    • Assists the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
    • Responsible for the recruitment and oversight of coordinator staff as well as ensures that staff has completed mandatory training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and participates in annual performance evaluations and competency assessments of research staff.
    • Assists the principal investigator in preparing manuscripts for publication.
    • Provides in-service training and serves as a resource to other clinical personnel including physicians, nurses, pharmacists and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations and site SOPs.
    • Oversees registration of protocol patients with QACT, study group registrar and pharmaceutical company as outlined in protocol.
    • Assumes responsibilities for data management. Maintains schedules and procedures necessary for timely and complete data collection. 
    • Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
    • Provides professional services related to IRB regulatory expertise, sample acquisition and genomic characterization of patient samples and models, as well as outcomes and clinical data collection and coordination.
    • Oversees and involves in sample collection, handling, and basic processing. Coordination of pathology and genomics data derived from specimens will also be a critical part of the position.
    • Other responsibilities include managing regulatory components of the model generation process and involvement in model development for clinical trials.

    Qualifications

      • Bachelor's Degree required.
      • Minimum of 3-5 years of related experience preferred.
      • Experience in protocol development, data compilation and analysis.
      • Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
      • Laboratory “wet” bench work or work with patient samples would also be preferred.
      • Expert knowledge of Federal and State regulations as they relate to research.
      • Must have the ability to function independently and lead, with little supervision.
      • Strong interpersonal, organizational and communication skills.
      • Experience working with databases, graphing and reporting software or data analysis software preferred.
    • Monday - Friday; 40 hours; flexibility to work outside of normal hours is expected to be required due to the clinical nature of the position.

      Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

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