Protocol Specialist

Beth Israel Lahey Health • Boston, MA

4d

About The Position

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. As a member of the CCI (Committee on Clinical Investigations) team, the Protocol Specialist is responsible for overseeing the submission process associated with the CCI, which is BIDMC's Institutional Review Board (IRB). The Protocol Specialist interacts with all CCI staff, as well as the entire research community in coordination of human research activities. Job Description: Essential responsibilities but not limited to: 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 Ensures accurate review and additional regulations are applied for protocols, including complex protocol review and protocols involving vulnerable populations Documents IRB submissions on a daily basis and enters details into the internal IRB database. Performs pre-review of IRB submissions for accuracy and compliance with IRB submission requirements. As part of the pre-review, requests missing information, as needed, to facilitate IRB review, and organizes review process for Vice Chairs. populations Assists in the initial review of Informed Consent Forms for new IRB submissions and in the coordination of the pre-meeting review process. Prepares and maintains files for Executive and Vice Chair Committee meetings, distributes agendas, prepares and distributes meeting packages, and assists with meeting preparation. Leads special projects identified by the IRB or HRPP Director. Serves as alternate IRB member Assists in planning educational events including the IRB Retreat and All Staff Meetings Serves as coverage for other staff as directed by IRB manager

Requirements

• Associate’s degree required, Bachelor's degree preferred.
• 3-5 years relative work experience required.
• 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.
• Teamwork: 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.
• 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.

Responsibilities

• 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
• Ensures accurate review and additional regulations are applied for protocols, including complex protocol review and protocols involving vulnerable populations
• Documents IRB submissions on a daily basis and enters details into the internal IRB database.
• Performs pre-review of IRB submissions for accuracy and compliance with IRB submission requirements.
• As part of the pre-review, requests missing information, as needed, to facilitate IRB review, and organizes review process for Vice Chairs. populations
• Assists in the initial review of Informed Consent Forms for new IRB submissions and in the coordination of the pre-meeting review process.
• Prepares and maintains files for Executive and Vice Chair Committee meetings, distributes agendas, prepares and distributes meeting packages, and assists with meeting preparation.
• Leads special projects identified by the IRB or HRPP Director.
• Serves as alternate IRB member
• Assists in planning educational events including the IRB Retreat and All Staff Meetings
• Serves as coverage for other staff as directed by IRB manager

Benefits

• Equal Opportunity Employer/Veterans/Disabled
• At Beth Israel Lahey Health, we are driving the change in health care that Massachusetts wants and needs. Our culture promotes continuous learning, growth, innovation and a sense of belonging. We make it a priority to offer comprehensive compensation and benefits and help you achieve a healthy and balanced life. While you're busy caring for and supporting our patients, we take care of you.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree