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Quality Management Specialist


Department Description: The Cancer Clinical Trials Office (CCTO) at Beth Israel Deaconess Medical Center (BIDMC) supports clinical research and provides infrastructure and services to the Cancer Center Disease Programs. Each disease group participates in a combination of phase I through phase IV trials that investigate new uses of FDA-approved drugs, as well as novel investigational agents. As part of a full-service hospital, these disease programs are able to provide cohesive, patient-focused, and comprehensive care for cancer patients involved in clinical research studies. The CCTO provides centralized guidance of new trial submission and oversight of all regulatory requirements; collaboration with the DF/HCC with seats on the IRB, SRC, and Operations Committee; and a liaison with the greater BIDMC oncology, research, and medical communities.

Job Location: Boston, MA

Req ID: 37609BR


Job Summary: The Quality Management Specialist in the Cancer Clinical Trials Office performs and coordinates monitoring of clinical trials in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols, conducts site visits to determine protocol and regulatory compliance, and prepares required documentation and develops collaborative relationships with the disease programs through quality improvement projects, education and training. The candidate must work both independently and in a team environment.

Essential Responsibilities:
  1. Participate and contribute to monitoring of cancer clinical trials including those sponsored by DF/HCC PI's and the NCI .
  2. Conducts audits for trials sponsored by industry, PIs, or the NCI across all disease groups within the CCTO. Reviews subject charts and regulatory binders
  3. Assists with onboarding new staff by way of distributing, tracking and explaining initial trainings required. Conducts Quality training for all new CCTO staff.
  4. Tracks and generates reports on audit findings across the office
  5. Troubleshoots office-wide issues and assists in preparation and implementation of office policies and procedures.
  6. Assists in various office projects relating to quality and education.
  7. Acts as a liaison on behalf of the BIDMC CCTO to the Dana-Farber Harvard Cancer Center (DF/HCC).
  8. Serves as a resource to disease teams for generating CAPAs and answering questions about the FDA, IRB, and good clinical practice (GCP).
Required Qualifications:
  1. Bachelor's degree in Life Sciences or related field required. Master's degree in Life Sciences or related field preferred.
  2. 1-3 years related work experience required in in clinical trials and/or regulatory.
  3. Demonstrate good understanding of FDA good clinical practice guidelines
  4. Must maintain confidential and sensitive information, set own priorities, and work both independently and
    collaboratively with other research and hospital personnel
  5. Demonstrate a positive, professional, and collaborative attitude with peers, supervisors, and colleagues.
    Must possess organization, time management and critical thinking skills
  6. Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis and maintain databases.
Competencies:
  1. Decision Making: Ability to make decisions that are guided by general instructions and practices requiring some interpretation. May make recommendations for solving problems of moderate complexity and importance.
  2. Problem Solving: Ability to address problems that are varied, requiring analysis or interpretation of the situation using direct observation, knowledge and skills based on general precedents.
  3. Independence of Action: Ability to follow precedents and procedures. May set priorities and organize work within general guidelines. Seeks assistance when confronted with difficult and/or unpredictable situations. Work progress is monitored by supervisor/manager.
  4. Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers.
  5. Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.
  6. Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
  7. Team Work: Ability to act as a team leader for small projects or work groups, creating a collaborative and respectful team environment and improving workflows. Results may impact the operations of one or more departments.
  8. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.

Physical Nature of the Job:
Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally

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