Human Research Quality Manager, MED School of Medicine, Clinical Research
Tracking Code 8513/J0616
The Boston Medical Center and BU Medical Campus Clinical Research Resources Office (CRRO) Human Research Quality Manager will be responsible for three important functions within the Human Research Protection Program: Managing the Research Coordinator Network, performing quality assurance monitoring and auditing on human research studies conducted at BMC and BU Medical Campus, and educating on and managing investigator compliance with registration and results reporting within ClinicalTrials.gov. Further specifics are detailed below.
- This individual will develop, maintain and manage a research coordinator network for the BMC and Boston University Medical Campus research staff who have research coordinator responsibilities (regardless of job title). The goal of the research coordinator network is to enhance opportunities for education, professional development, and networking and to share best practices for the conduct of clinical and human research. The Human Research Quality Manager will collaborate closely with the CRRO Regulatory Education Manager to modify current and develop additional coordinator-specific educational opportunities in clinical and human research. To ensure a strong and vital research coordinator network, this individual will interface and engage with research coordinator members, the advisory board, and the leadership committee and provide needed management and administration to facilitate communication and implementation of network initiatives.
- This individual conducts on-site reviews of IRB-approved research studies to ensure that research is conducted in compliance with applicable regulations, policies, and guidance. These include both for-cause audits as well as not-for-cause (Quality Assurance) reviews of human and clinical research studies at BMC and BU Medical Campus.
As a function of the QA role, this individual will provide assistance to clinical researchers regarding regulatory aspects to the conduct of research throughout the life of the study, especially concentrating on issues that come up in QA reviews. He/she will work with the CRRO Regulatory Education Manager in identifying and developing educational priorities. May assist in investigator consultations including questions on study implementation, assistance with FDA IND/IDE requirements, informed consent process and issues, HIPAA issues, DSMP development, etc.
- Provides oversight to ensure compliance with clinical trials registration and results reporting in ClinicalTrials.gov. This includes providing education and support to investigators on the requirements for registration results reporting. This individual will work with Principal Investigators and their study teams to ensure that they understand and fulfill their registration/reporting requirements, work with the grants offices to identify research studies that require registration/results reporting and identify those that are not in compliance and assist those teams in reaching compliance.
The Human Research Quality Manager will also be involved in local and national efforts to support the conduct of clinical research, especially as it pertains to coordinators and other research support staff. This includes involvement in Clinical Translational Science Award (CTSA) taskforces and subcommittees related to research coordination, regulations, research conduct, auditing, and registration.
This role requires a Bachelor's Degree at least 3 years of experience working as a clinical research coordinator role (project manager, research assistant, study coordinator, etc.) is required. Master's Degree preferred.
Experience in the following is desired:
- Experience in auditing human research studies is preferred, but if no direct experience in this area then expertise in human subjects protection regulations and FDA regulations for drug, biologic, and device research may be acceptable.
- Trial registration and results reporting on ClinicalTrials.gov.
- Experience with conduct of clinical research with pharmaceutical/device clinical trials and/or socialbehavioral and/or public health research.
- Knowledge of HIPAA regulations for research.
- Experience submitting IRB applications and managing IRB submission efforts.
- Prior experience working as IRB staff is beneficial to the job, but not required.
- Excellent interpersonal skills required. Must be comfortable giving presentations to and working with small and large groups of people.
- Detail oriented. Ability to multi-task.
- Strong computer skills, including experience with databases, spreadsheets, Microsoft PowerPoint, word processing, etc.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.