Background: The Department of Research Operations is responsible for overseeing the contracting process and financial management of research and programmatic grants, contracts, and agreements at BMC. The office is organized by: 1. Pre-award's submissions and Research Finance's management of federal, foundation, and private funding sources; and 2. Clinical Trial Office's (CTO) pre-award negotiations and financial management of Human Subjects Research funded or sponsored by Industry. In addition, the CTO is responsible to ensure fluid clinical research operations are facilitated within BMC's clinical infrastructure, which includes but is not limited to, developing workflows with ancillary service departments, centralizing research fee schedules, and overseeing research billing compliance regardless of the funding source. There is significant support within Research Operations to sustenance BMC's research portfolio such as: Research Attorneys who reviews all BMC affiliated research contracts, Research Information Systems who supports Research Ops IT needs, and Research Compliance who evaluates risk to the institution and implements policy and process to mitigate.
Description of Internship: The CTO collaborates with hospital leadership to integrate clinical research within the inpatient and ambulatory settings. In a post COVID world, hospitals are reinventing how we continue to provide safe, exceptional, and reputable care for our patients. Human subject research protocols are directly affected by this new world order, and were written to exist in a pre-COVID world. Boston Medical Center and Boston University Medical Campus have created a Research Re-start Task Force to determine the priority of which protocols and staff can return to campus.
This internship would manage the human subjects research re-start review process for BU and BMC medical campuses and would be responsible to: 1. Evaluate the human subject protocols submitted for re-start and consult with the study teams, sponsors, and IRB on how to possibly re-design the protocol requirements to limit staff and patient volume on campus, and 2. Organize protocol submission data based on re-start priority and 3. Discuss protocol data collection alterations with Research Restart Task Force for in-person research review.
This internship would focus on and gain exposure to drafting Standard Operating Procedures and developing administrative oversight with stakeholders. It will be ideal for someone looking to gain exposure to both the research administrative oversight at an academic safety net hospital and incorporating new medical practices in a post-COVID world.
Professional Development Objectives/ Benefits to the intern:
- Exposure to research administration, more specifically research process management and data analysis
- Draft or edit research operations policies
- Assess future career opportunities in research administration
Responsibilities of the intern:
- Collaborate with Director, Clinical Trial Office to develop a robust research re-start program
- Collaborate with assigned Research Operations staff to design and follow workflow of re-start information submitted
- Develop relationships with study teams, sponsors, and IRB to re-design protocol required human subjects data collection to meet the restriction needs of the hospital and main integrity of the research
- Present and engage in conversation with Research Restart Task Force on protocols for review
- Identify and work with Research Operations SOPs and policy stakeholders to draft assigned policies
- Adhere to BMC policies
- Primary contact- Johanna Chesley, Director, Clinical Trial Office
- Mentors- Research Re-start Committee Task Force- made up of physicians,
Skills/Experience/Qualifications of Intern:Experience in clinical research preferred. Must be proficient in Microsoft Office products (i.e. Excel, Word, Outlook, PowerPoint). Project management experience a plus. Legal experience encouraged but not required.
Duration: 6-12 month commitment preferred, but semi-flexible, which would include a 6-week probationary period.
Desired Time Commitment: Part-time: 16-20 hours per week preferred, but semi-flexible.
Can work be performed remotely? 100% for the foreseeable future. BMC laptop will be provided.
Req ID: 15666