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Reporting to the Senior Project Manager of SFARI Cohorts, the Project Manager will be responsible for the following: managing Research Match for the SFARI cohorts, advising on day-to-day issues related to compliance and overseeing of the Collections team (e.g., request processing), see below for details.
- Research Match: Research Match is the process by which existing SFARI cohort participants are recruited into a new, approved research project, as well as processes that occur during and after the launch of that project (e.g., tracking consent rates, troubleshooting workflow issues). The Project Manager will oversee other SFARI staff in facilitating assigned projects through the Research Match process, including issues related to compliance, study workflow, participant privacy and experience, and project troubleshooting, bringing issues to the Senior Project Manager as needed.
- Compliance: For compliance, the SFARI cohorts are actively recruiting participants and distributing data, so IRB and compliance issues arise on a regular basis. The Project Manager would work with SFARI staff to advise on day-to-day questions and issues related to research compliance, participant privacy and confidentiality, and IRB-related matters, including submitting and tracking changes in research (or supervising those who do). Examples include promptly reportable events, clinical site-related issues, resolving participant questions (e.g., guardianship issues) and advising SFARI staff on what must be submitted to the IRB and how. Working with the Vice President of Administration and Senior Project Manager, the Project Manager may also help with compiling reports and summaries or troubleshooting issues related to compliance.
- Collections: Finally, the Collections team is tasked with facilitating researcher requests for SFARI resources, including data, biospecimens and Research Match. The Project Manager will be responsible for day-to-day oversight of the Collections team, including high-level tracking of request processing and supervision and review of incoming annual compliance documentation.
The break-down of time spent in each area is subject to change but estimated to be approximately 50 percent Research Match, 30 percent compliance, 20 percent Collections.ESSENTIAL FUNCTIONS/RESPONSIBILITIES
- Manage daily compliance needs for SPARK and other SFARI cohorts, including advising on participant and clinical site issues, drafting or reviewing language, and overseeing IRB submissions and tracking.
- Create standard operating procedures and tracking documents related to compliance, collaborating with other staff as needed to develop, review and revise processes related to their team.
- Delegate to and monitor junior staff in keeping documents updated, filing approved materials, completing summaries, etc.
- Advise on and edit protocols, consents and other documentation, as needed.
- Write and/or review IRB submissions for accuracy and compliance with human participants research regulations.
- Communicate compliance-related issues to the Senior Project Manager and Vice President of Administration, as needed.
- Manage assigned Research Match projects in collaboration with Research Coordinator, including the review of study procedures, workflow and participant eligibility, facilitating review of documents for IRB approval and testing/monitoring the project build and launch (approximately 50% of effort).
- Raise issues related to Research Match projects to Senior Project Manager, as needed.
- Support the overall management of the Collections team and SFARI Base.
- Monitor all processes related to Collections and SFARI Base, many of which are performed by junior staff, including request fulfillment timelines, annual compliance task completion by institutional officers and Principal Investigators (PIs), and the Zendesk ticketing system.
- Advise junior staff on compliance-related issues for Collections, including review of compliance documentation for research projects and associated resource requests, data sharing and participant confidentiality/privacy protection.
- Facilitate signing of the Researcher Distribution Agreement between new institutions and the Vice President of Administration.
- Hold meetings to facilitate efficient request processing (e.g., with the SFARI biorepository).
- When necessary, directly facilitate (e.g., by screen share, phone call, email) assisting PIs with signing up for SFARI Base, requesting resources and/or data utilization.
- Implement a system for gathering feedback from PIs who utilize SFARI Base and summarize and make recommendations for changes to SFARI Base and/or request processes based on this feedback.
- Organize and monitor key timelines, milestones and deliverables to ensure that assigned areas operate in an efficient manner.
- Produce detailed progress reports, summaries and presentations, as directed.
- Participate in SFARI and SPARK team meetings, as appropriate.
- Aid other SPARK-related projects, as needed.
- Master's degree preferred
Related Skills & Other Requirements
- Five years of experience in a related field
- Experience with Institutional Review Board procedures and ethics of human subject research
- Experience with HIPAA and/or best practices related to participant privacy and confidentiality
- Strongly preferred: experience with ticketing systems, research administration and supervising staff
REQUIRED APPLICATION MATERIALS
- Sound judgment and discretion
- Excellent interpersonal skills with all levels of the organization and external communities
- Excellent verbal and written communication skills
- Ability to maintain a high degree of confidentiality
- Comfort working independently but also in a collaborative team environment
- Takes initiative and proactively manages timelines and action items to ensure timely attainment of goals
- Strong administrative and organizational skills with attention to detail and ability to balance workload under deadlines and multiple commitments
- Strong computer skills, particularly with email, Excel and word-processing programs
The Simons Foundation's Diversity Commitment
- Please submit a resume and cover letter stating your interest in the position.
Many of the greatest ideas and discoveries come from a diverse mix of minds, backgrounds and experiences, and we are committed to cultivating an inclusive work environment. The Simons Foundation actively seeks a diverse applicant pool and encourages candidates of all backgrounds to apply. We provide equal opportunities to all employees and applicants for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, genetic disposition, neurodiversity, disability, veteran status or any other protected category under federal, state and local law.
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