• Clinical Research Assistant

    New England Cancer Specialists (Westbrook, ME)


    Job Descriptions:

    New England Cancer Specialists (NECS) is seeking a fulltime Clinical Research Assistant in our Westbrook Clinic. The Research Assistant will work within a dedicated Research Department in an outpatient setting, providing professional research and study support for assigned clinical research protocols. Responsibilities include assisting with patient recruitment and the management of volunteer subjects in compliance with study protocols, FDA regulations, and sponsor and practice requirements. The Research Assistant will also support the regulatory management of research projects from study start-up through close-out, under the guidance of the Regulatory Specialist.

     

    NECS is a private medical practice composed of 18 oncologists and hematologists serving the region from four separate locations in Maine and New Hampshire. Our mission is to make life better for people with cancer and blood disorders. Kindness, compassion, and respect are part of everything that we do - from our phone operators to our physicians, every person on our team is important, and everyone makes a difference every day. We are proud to be the first Dana Farber Affiliate practice in the country, striving to provide the highest quality care and unmatched, holistic support for every patient, every day.

    Job Duties:

    + Provide departmental support activities as necessary. Examples include: ordering/shipping/receiving of study materials, inventory management, data entry, regulatory, etc.

    + Assist in the maintenance of regulatory files (financial disclosures, FDA forms, NCI forms, CVs, medical license, etc.) for clinical trials within an eRegulatory platform

    + Assist in providing sponsor access to electronic systems (OncoEMR, Florence,

    + Assist in preparation for institutional, pharmaceutical and internal audits

    + Facilitate PI and study staff protocol and industry level training

    + Assist in screening, enrollment and retention of volunteer patients

    + Develop, facilitate, and maintain medication dispensation and usage records during study activation

    + Assist in managing the archiving process and organization of legacy study documents

    + Track and manage equipment calibration and temperature logs across all sites including monthly and annual calibration

    + Maintain database/spreadsheets/files as necessary to facilitate tracking/documentation of departmental activities

    + Stay up-to-date with new and revised standard operating procedures and regulations

    + Maintain compliance with good clinical practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws

    + Ensure confidentiality of patient records and data: HIPAA compliance

    + Performs miscellaneous, job-related activities as assigned

    Required Experience:

    + Associate’s degree in related field or equivalent work experience in the clinical setting.

    + A minimum of 1-2 years of work experience with clinical trials, or a combination of clinical trials and relevant work experience preferred.

    + CITI certification preferred. Must be able to complete CITI program upon hire.

    + Oncology experience preferred.

     

    Keyword: Clinical Research Coordinator, trials, research

     

    From: New England Cancer Specialists