Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics

Job Description

This is a newly created full-time position for a post-doctoral employee fellow in clinical research ethics to support the work of the Petrie-Flom Center at Harvard Law School in its collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, Harvard’s Clinical and Translational Science Center. The fellow must have strong knowledge of clinical research and its regulation, with particular interest in the regulatory, ethical, and practical aspects associated with recruitment and retention of research participants. The position will provide the opportunity to interact with a wide range of stakeholders, such as IRB members, administrators, investigators, institutional leadership, patient advocates, and other community members. This position allows for a maximum of 10% effort in furtherance of the fellow’s own research agenda(s) in related fields. Illustrative projects include the following:

Defining the clinical trials recruitment problem, including cataloguing various barriers to recruitment, outstanding data needs, and possible solutions, and developing a research agenda
Evaluating whether there are ways to prioritize trials and allocate research participants as a scarce resource
Considering innovative trial designs as a potential mechanism to address the recruitment problem
Developing a recruitment/retention toolkit to help investigators develop successful recruitment/retention plans
Addressing the proper parameters of remuneration to subjects
Developing surveys to learn more about participant motivations, expectations, and concerns
Conducting additional empirical research to develop knowledge that can improve clinical trial recruitment/retention

Reporting to the Petrie-Flom Center’s Executive Director, and interacting with the Center’s Faculty Director, Program Leadership at Harvard Catalyst, and other Catalyst staff, the fellow will bear primary responsibility for the day-to-day work necessary to complete project deliverables. It is essential that the fellow be able to work both independently and collaboratively, with frequent team meetings and weekly project status reports.

Responsibilities will include at least the following, covering both academic and administrative duties:

Conduct conceptual law, policy, and ethics research
Conceptualize empirical studies and shepherd the process of IRB review, where needed (empirical research capabilities are a bonus)
Draft guidance documents and practical materials for IRBs and investigators (e.g., FAQs, points to consider, checklists, training modules, flow charts, etc.)
Develop manuscripts for co-authored publication
Organize and run working groups (develop agendas, take minutes, delegate tasks, advance action items, generate group output, etc.)
Collaborate with other academic research institutions working on similar projects
Draft slides and presentation materials
Organize workshops and conferences to obtain expert input and disseminate results
Collaborate in identification of new research priorities, launch of projects related to the Program mission, and proposal development, potentially to include grant writing
Oversee a simple program budget (including liaison with grants managements and finance offices, at HLS and HMS)
Annual and all other reporting
Maintain up-to-date web text regarding program work and projects

The fellow may also be asked to blog periodically at Bill of Health, the Petrie-Flom Center’s blog.

Basic Qualifications

Doctoral-level degree, received within the last three years, in law, ethics, or related discipline (J.D., Ph.D., M.D., etc.), with a background in the regulation of clinical trials and major issues in research ethics.
Proficiency with online medical research tools

Additional Qualifications

Superb research and writing skills, including proficiency with Westlaw, Lexis, PubMed, MedLine, and other research tools
Excellent judgment, attention to detail, organizational skills, and communication abilities
Creativity and willingness to pursue novel solutions
Flexibility to adjust to changing circumstances and program needs
Interest/expertise in issues related to clinical trial recruitment and retention
Experience working with academic research institutions, IRBs and ethics committees, and researchers
Experience staffing substantive academic or government committees
Empirical research skills, quantitative and qualitative
Experience authoring academic publications and/or training materials

For more information and to Apply, view the full Job Description!