Beth Israel Deaconess Medical Center Regulatory Coordinator in Boston, Massachusetts
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Department Description: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.
Job Location:Boston, MA
Job Summary:The Regulatory Coordinator performs all basic regulatory administrative tasks such as submitting protocol related documents and updates to the Dana Farber/Harvard Cancer Center (DF/HCC) IRB and audits. 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.
Works with study teams to update essential study documents. Submits appropriate study documents, sponsor manuals & Investigator Brochures to regulatory authorities in a timely fashion. Responds clearly & promptly to questions & comments from IRB and/or sponsor. Completes application forms accurately & with attention to detail. Works with study teams to prioritize competing submission requirements
Creates and maintains Regulatory Binders for active trials in the assigned disease teams
Reviews external audit reports, assessing for regulatory findings. Rectifies identified issues and tracks trends and patterns
Maintains and tracks all necessary protocol training for new and current staff. Submits study staff updates to regulatory authorities and sponsors in a timely fashion. Initiates and maintains delegation of authority (DOA) logs, and Form 1572s, ensuring time sensitive updates are made appropriately. May assist with the completion of financial disclosure forms
Works with physician investigators, sponsors and program managers to create accurate consent forms. Able to abstract complex scientific and medical language and distill this information at patient-appropriate reading level. Reformats text and tables as needed.
May be tasked with assisting in Serious Adverse Event (SAE) reporting, IND submissions and safety reporting, and notification of protocol non-compliance (deviation and violation reporting) with the IRB and/or sponsor and/or other regulatory bodies. Completes assigned reports in mandated time frames.
May be tasked with assisting disease teams with trial start-up activities, including scheduling of Site Initiation Visits (SIVs), obtaining departmental sign offs, and confirming that all preparatory work is complete.
Associate's degree required. Bachelor's degree preferred.
0-1 years related work experience required in preferably in healthcare or clinical research..
Must maintain confidential and sensitive information.
Able to work independently with limited to moderate oversight. Where needed, able to collaborate with study teams and other regulatory staff
Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
- Basic knowledge of FDA, cooperative group, NCI and or OHRP regulatory guidelines
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.
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.
Independence of Action:Ability to follow general instructions and procedures as provided. Work is monitored by supervisor/manager.
Written Communications:Ability to communicate clearly and effectively in written English with internal and external customers.
Oral Communications:Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.
Knowledge:Ability to demonstrate basic knowledge of fundamental concepts, practices and procedures with the ability to use them in routine situations. Specialized knowledge not required.
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.
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