Joslin Diabetes Center

  • Clinical Trials Manager (Immunobiology)

    Location US-MA-Boston
    Posted Date 1 month ago(4/26/2018 12:00 PM)
    Job ID
    N3061-18
    # Positions
    1
    Category
    Research - Research
  • Overview

    The Clinical Trials Manager provides comprehensive operational support for the Principal Investigator’s clinical trials portfolio including study team management, protocol development for investigator-initiated studies, overseeing Clinical Research Organization interactions, as well as execution of coordinator responsibilities as necessary.

    The Clinical Trials Manager ensures that clinical trials are conducted in accordance with study protocols in a manner that is compliant with regulatory guidelines, local policies and within study budgets.

    Responsibilities

    • Provides comprehensive oversight of operational aspects of Principal Investigator’s clinical trials portfolio including protocol development for investigator-initiated studies, management of study team, as well as execution of coordinator responsibilities as necessary.
    • Contributes to protocol development for investigator-initiated clinical trials. This may include liaising with collaborators, performing background research, and writing and/or revising portions of the protocol, informed consent form(s), and other study related materials.
    • Manage multiple members of the clinical research team with the Principal Investigator. Is reported to by members of the clinical research team for purposes of daily work planning and scheduling, ensures that work of team members is completed in a timely manner. Schedules and coordinates weekly meetings for clinical research team. Ensures timely completion of human subjects training and certification for all study team personnel involved in clinical research.
    • Management of Clinical Research Organization (CRO) interactions. Works with the CRO and Joslin Office of Sponsored Research (OSR) to establish or revise scope of service agreements, budgets, plans, and timelines.
    • Works with study sponsors’ monitors including review of monitoring reports and ensuring timely and accurate responses to queries. Makes recommendations for corrective action plans if needed.
    • Provides informal and formal presentations to professional and lay audiences.
    • Monitors progress of studies. Identifies potential delays and study related issues and makes recommendations for solutions.
    • Reviews contracts, provides support for invoice generation including tracking passthrough costs, and reconciles payments. Serves as a liaison between the Principal Investigator and the Office of Sponsored Research and Fiscal Services at Joslin.
    • Participants in the hiring, training, and supervising of the research team.
    • Assures that all study procedures are completed and documented per protocol including those performed by other team members.
    • Ensures timely notification to investigators of abnormal findings, participant or sponsor concerns.
    • Oversees and/or performs coordinator duties as needed including study subject recruitment, consenting study subjects, maintaining study documentation, completing case report forms, preparing IRB submissions, scheduling visits, making participant travel arrangements within sponsor guidelines, sample processing and shipping of samples to outside laboratories, and performing other components of research protocols as necessary.
    • Manages required documentation/communication on paper and electronically, adhering to standards set forth by federal and private sponsors of trials. Maintain all records to FDA audit criteria. Create and maintain regulatory and clinical record binders with appropriate documents for each trial.
    • If licensed to do so, dispense or administer study drug(s) under direction of supervising physician. This includes intravenous infusion of medications.
    • Collect study data and samples that are within scope of practice, licensure, and training.
    • Ensures that study medications are monitored for temperature under locked conditions and dispensed in accordance with study protocols. Ensures that study drug/placebo is available as dictated by study protocols. Works with internal pharmacist(s) to ensure adequate coverage and supplies for study visits.
    • Document and communicate all serious adverse events and MedWatch reports to institutional review boards, sponsors, and other facilities as warranted and according to set timelines.
    • Ensures timely submission of progress reports including those to institutional review boards and sponsors.
    • Act as a liaison with study sponsors; conducting initiation visits, interval site visits by monitors, and study close out visits. Interact with FDA or other external auditing parties as required.
    • Participate in study teleconferences, attend team meetings, and may attend national study meetings.
    • Provides various administrative support functions.
    • Communicate clinical trial updates to staff.
    • Supervises the storage and use of the study related materials.
    • Coordinates with internal and external laboratories and vendors to ensure adequate study supplies and sample processing and assay.
    • Performs ad hoc statistical analysis for the Principal Investigator using statistical programs available at Joslin.
    • May participates in the preparation of scientific publications and presentations of scientific data.
    • Other duties as assigned.

    Qualifications

     

    • Bachelors Degree in a research related field (Masters or Doctorate preferred) OR Associate’s Degree in Nursing (Bachelor’s Degree strongly preferred).
    • Ideally 5 years of clinical research experience including study coordination and CRO/vendor interactions or 2 years clinical research experience if have a clinical research certification (ACRP or SOCRA).
    • If Registered Nurse, Massachusetts License

    • Clinical research certification such as Certified Research Study Coordinator from the Association of Clinical Research Professionals or Certified Clinical Research Professional from the Society of Clinical Research Associates. If does not have such certification expected to obtain within first 6 months of the job as a condition of employment.
    • Demonstrated computer skills for major office applications (i.e. Microsoft Office including Word, PowerPoint, Excel and Outlook), databases, and technology to track coordinate and administer multiple concurrent clinical trials.

    • Knowledge of clinical, research, and federal grant regulations to ensure accurate execution of protocols and preparation of all documentation.

    • Excellent interpersonal, organizational skills, and communication skills.

    • Ability to maintain confidentiality.

    • Skill in working independently and following through on assignments with minimal direction.

    • Ability to manage administrative complexity arising from multiple concurrent studies.

    • Flexible schedule as necessary to accommodate study patients and recruitment activities.

     

    Joslin Diabetes Center is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status or any other status protected by law.

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