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Req ID: 37441BR
Job Summary: As a member of the CCI (Committee on Clinical Investigations) team, the IRB Analyst is responsible for overseeing the submission process associated with the CCI, which is BIDMC's Institutional Review Board (IRB). The IRB Analyst interacts with all CCI staff, as well as the entire research community in coordination of human research activities.
- Serves as the point of contact for the research community and IRB members for education on IRB processes, regulations, and institutional policy regarding research and the IRB.
- Responds to requests for information from Principal Investigators, research administrators, internal support personnel, as well as, SMART IRB point of contacts, external institutions, and external Principal Investigators and their staff that are involved in multisite projects with BIDMC, and outside sponsors via phone, e-mail, and direct contact.
- Works closely with the Reliance Specialist to assist with determining when a reliance agreement is needed, manage local context review, and assist with administrative changes to cede applications.
- Prepares and maintains files for Executive and Vice Chair Committee meetings, distributes agendas, prepares and distributes meeting packages, and assists with meeting preparation.
- Serves as the liaison and assists in the coordination of the pre-meeting review process for all studies conducted across Beth Israel Lahey Health (BILH) and Mount Auburn Hospital.
- Facilitates process to execute Institutional Authorization Agreements and Individual Investigator Agreements, including new user requests for SMARTIRB reliance.
- Serves as the coordinator for external IRB file storage
- Leads special projects identified by the HRPP Director.
- Bachelor's degree required.
- 3-5 years related work experience required in Related work experience.
- 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.
- Decision Making: Ability to make decisions that are based on specific instructions, standard practices and established procedures which generally require little or no supervision.
- 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 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.
- 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 full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
- 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.
- 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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