Regulatory Assistant (An excellent opportunity for a recent college graduate)
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
Req ID: 32028BR
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