Program Manager

Position Summary

The Division of Women’s Genetics in the Department of Obstetrics and Gynecology is seeking a program manager to support the Clinical Director of Genetics and the Associate Director of Women’s Genetics Research in executing the aims of the division. The individual will coordinate, monitor and manage all administrative items relating to Director and research portfolio supervised by the Associate Director. This role will also include management of the CLARUM project, funded by ARPA-H.

Responsibilities

Administrative Management:

• Oversee the scheduling of meetings for relevant stakeholders in ad hoc projects.
• Assist with writing reports and manuscripts detailing research findings, program updates and others as applicable.
• Conduct relevant literature reviews as needed.
• Supplies: ensure that all supplies are ordered and shipped as needed.
• Monitor of sponsored research expenditures for assigned protocols.
• Support the development of workflows to improve operational efficiency and consistency.
• Coordinate communication and follow up with internal teams and external partners to support project execution.

Regulatory Management:

• Coordinate and manage regulatory procedures for human subject research (e.g., IRB protocol, consent forms, interview data) for assigned protocols.
• Responsible for preparation of documents for renewals, modifications, yearly submissions, correspondence, and audits related to IRB for multiple ongoing NIH-sponsored research studies in genetics.
• Assist in the preparation of annual reports including regulatory information to funding and regulatory agencies.
• Ensure that regulatory compliance is met and that regulatory files are audit-ready.
• Monitor and verify that all research staff are using up to date IRB approved study documents. Updating and distributing revised versions promptly to maintain compliance.
• Manage MTAs/DUA’s for projects as applicable.

Research Coordination:

• Screen, recruit, and consent patients to genetics projects as needed.
• Coordinate research samples including, processing, storing and shipment with cross coverage for Women’s Genetics Center sample coordination.
• Coordinate follow up for various genetics projects including sending surveys, completing research interviews, and data entry
• Assist in transcription and coding of interview data to support qualitative and quantitative analysis.
• Maintain accurate and organized study records, databases and files to ensure regulatory compliance.
• Assist in the development and implementation of study materials such as protocols, consent forms and relevant surveys.
• Support the development of study documents such as SOP’s, training materials and tracking logs.

ARPA-H CLARUM Management (50%)

• Develop and adhere to project timelines and milestones.
• Set agendas for project operations meeting and follow up on action items to maintain progress.
• Attends study team meetings and trainings.
• Consent patients in reproductive arm of study (task 3) and coordinate samples with laboratories.
• Coordinate contracts with external vendors and monitoring deliverables and invoice processing.
• Oversite of all relevant IRBs and manage protocol and consent development for sites.
• Coordinate and support discovery duo activities.
• Manage program’s data processing, transfer and retrieval of samples as needed.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Requires bachelor’s degree or equivalent in education and experience, plus four years of related experience.
• Strong interpersonal and organizational skills.
• Ability to exercise initiative and judgment.
• Team player with ability to thrive in busy office environment.
• Ability to think and write clearly and to edit materials accurately.
• Ability to work under pressure and meet deadlines.
• Ability to handle multiple projects simultaneously and prioritize tasks while maintaining responsibility for timely execution.
• Working knowledge of Microsoft Office: Word, PowerPoint, Excel and Access.

Preferred Qualifications

• Bilingual in English and Spanish.
• Experience with REDCap or other clinical research data systems.
• Experience with genetics.

The Department of Obstetrics and Gynecology is dedicated to the goal of building a multicultural faculty and staff committed to teaching, working and serving in a diverse community, and strongly encourages applications from candidates of traditionally underrepresented backgrounds.

We are continuously seeking to recruit individuals who will enhance the diversity of our workplace and the effectiveness of our organization.