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Regulatory Specialist

Department Description: The Cancer Clinical Trials Office (CCTO)
The CCTO provides infrastructure and services to 13 individual cancer disease programs. This group oversees 34 clinical research assistants and coordinators, 18 research nurses/Research NPs, 6 Clinical Trial Specialists, 7 Regulatory and Quality Specialists, 5 Program Managers, 2 Clinical Pharmacy Personnel, 1 Program Coordinator, 1 Nursing Director, 1 Operations Manager and 1 Administrative Director who oversee nearly 500 clinical trials. The CCTO provides the following: Centralized coordination of new trial submission and oversight of all regulatory requirements; Hiring, training, and mentoring to all CCTO staff members; Guidance and support to all disease groups within the CCTO; Collaboration with the DF/HCC with seats on the IRB, SRC and Operations Committee and acts as liaison with the greater BIDMC oncology, research and general communities.

Job Location: Boston, MA

Req ID: 30300BR

Job Summary: The Cancer Clinical Trials Office (CCTO) at Beth Israel Deaconess Medical Center (BIDMC) supports clinical research and provides infrastructure and services to 12 individual cancer disease programs: AIDS Oncology, Breast Oncology, Cutaneous Oncology, Experimental Therapeutics, Gastrointestinal Oncology, Genitourinary Oncology, Gynecological Oncology, Hematological Malignancies/Bone Marrow Transplant, Radiation Oncology, Renal Oncology, Thoracic Oncology, and Thrombosis/Benign Hematology.

Essential Responsibilities:
  1. Prepare and submit applications, including preparation of consent forms to the DFHCC IRB on all cancer center clinical trials (industry, cooperative groups and PI initiated studies), and respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients.
  2. Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations and deviations to study protocols.Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoots processes and procedures when issues are identified.
  3. Assist investigators and study teams in preparing and submitting IND applications to the FDA. Preparation and submission of annual reports to the FDA. Submission of regulatory documents to NIH/OBA, local bio safety committees on oncology human gene transfer trials.
  4. Act as a liaison between the DFHCC IRB and investigator to resolve regulatory queries and concerns.
  5. Assist in the preparation and implementation of regulatory office SOPs.
Required Qualifications:
  1. Bachelor's degree required in Life Science or related field.. Master's degree preferred in Regulatory Affairs
  2. 1-3 years related work experience required.
  3. One - three years of previous clinical trial regulatory affairs experience.
  4. Must demonstrate good understanding of FDA, cooperative group, NCI and OHRP regulatory guidelines.
  5. Must maintain confidential and sensitive information, set own priorities, and work both independently and collaboratively with other research and hospital personnel.
  6. Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
Preferred Qualifications:
  1. Five years equivalent experience in a clinical research and regulatory environment.
  1. Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers.
  2. Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.
  3. Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
  4. Team Work: Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.
  5. 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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