• Regulatory QA Specialist CMCF

    Location US-MA-Boston
    Job Posted Date 2 months ago(8/22/2018 2:17 PM)
    Job ID
    2018-12263
    Category
    Medical Technologist/Clinical Lab
    Type
    full time
    Grade
    22
  • Overview

    The positions report directly to CMCF Administrator Director and will support the mission and goals of the DFCI-CMF clinical research program. This position will work closely and collaboratively with a variety of faculty and staff at all levels throughout both DFCI and DF/HCC, including faculty, investigators and clinical trials experts, representatives from the pharmaceutical, biotechnology, and medical device industries, federal and international agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Quality Assurance of Clinical Trials (QACT), and the Clinical Trials Education Office (CTEO), as well as clinical trials offices at other DF/HCC institutions. Coordinates, communicates, and supports PI and study teams throughout DFCI. May serve as a member of various institutional and department/division committees.

     

     

    Responsibilities

    1. Responsible for reviewing, reporting on and activating all protocols and protocol consents that involved the CMCF for CMCF requirements.
    2. Assists investigators and study teams in the planning and development of protocols; prior to formal submission for review and approval if CMCF is involved. May participate in other protocol development activities and execute other assignments as warranted and assigned.
    3. Provides guidance on the development of protocol documents including how to develop a protocol that meets SRC/IRB and CMCF requirements
    4. Reviews protocols to ensure compliance with DF/HCC administrative policies and procedures, administrative completeness, and compliance with key regulatory requirements. Addresses other aspects of study design in order to facilitate timely review and approval of the trial and the safe, effective, and efficient conduct of study at DFCI.
    5. Provides guidance to investigators and study teams regarding completion of regulatory submissions including SRC/IRB applications, amendments, and annual continuing reviews.
    6. Provides recommendations on how best to address specific issues and concerns raised through the scientific review and IRB review process.
    7. Serve as a centralized resource for off-site Sponsor-Investigators and study teams.
    8. Assists in the development and execution of training concerning regulatory submissions and IND/IDE management as necessary.
    9. Provides ongoing assistance in the creation and submission of all regulatory filings to FDA and EMA, (primarily Investigational New Drug (IND) and Investigational Device Exemption (IDE)).
    10. Provides oversight and advice to investigators (and the sponsor-investigator if he/she is not the PI) regarding IND/IDE determination; guidance and assistance in preparation of IND/IDE applications; coordination of IND/IDE submissions; and coordination and oversight of IND/IDE related activities (e.g., IND reporting, IND amendments); and ensure compliance with local, federal and international requirements.
    11. Develops and maintain a centralized IND/IDE database across all therapeutic / clinical areas; including capturing and reporting issues with submission documentation review and approval cycles.
    12. Provides ongoing assistance in the creation and submission of all regulatory filings to FDA and EMA, (primarily Investigational New Drug (IND) and Investigational Device Exemption (IDE)). Provides oversight and advice to investigators (and the sponsor-investigator if he/she is not the PI) regarding IND/IDE determination; guidance and assistance in preparation of IND/IDE applications; coordination of IND/IDE submissions; and coordination and oversight of IND/IDE related activities (e.g., IND reporting, IND amendments); and ensure compliance with local, federal and international requirements.
    13. Develop and maintain a centralized IND/IDE database across all therapeutic / clinical areas; including capturing and reporting issues with submission documentation review and approval cycles for CMCF specific trials not going through the normal route.
    14. Responsible for building BOE templates based on the protocol requirements
    15. Responsible for submitting annual updates to the IRB for CMCF specific protocols or INDs
    16. Responsible for reporting all problems regarding devices and supplies to MEDSUN
    17. Responsible for collating, trending, and reporting on deviations and protocol violations.
    18. May be required to enter data into other CMCF data repositories as needed.
    19. All other duties as assigned.

    Qualifications

    Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipline is required; Master’s degree in Regulatory Affairs or other advanced degree highly preferred. 3-5 years of direct regulatory experience required. Must have knowledge of US and international drug, biologic, and device regulations. Previous experience designing and implementing regulatory strategies to obtain, maintain and extend investigational approval and product registrations for drug, biologic and device products is preferred. Previous experience in the conduct of clinical trials highly desirable.

     

    KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

      1. Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills.
      2. Must have the capacity to comprehend complex structures and connections and be willing to adapt within a rapidly changing environment.
      3. Must have the ability to exercise good judgment in ambiguous situations under pressure, and have strong coping skills. Requires exceptional organizational skills and the ability and initiative to prioritize and handle a variety of tasks and assignments simultaneously.
      4. Must be proficient in the use of computers, Microsoft applications and databases.
      5. Must have demonstrated analytic and problem solving skills and have the ability to effectively manage a large workload independently with minimal supervision.
      6. Requires experience with.
      7. Ability to work with a diverse group of individuals at DFCI and elsewhere.
      8. Possess good organizational and communication skills.
      9. Ability to set work priorities in times of overload.
      10. Ability to function well under stress.
      11. Ability to work as part of a team.
      12. Ability to learn new skills and adapt to change.
      13. Knowledge of medical terminology, hematologic, oncologic and scientific terminology a plus.
      14. Comfortable learning and navigating various computer programs.

     

     

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