Clinical Research Project Manager

Clinical Research Project Manager

The Department of Biomedical Informatics at Columbia University is seeking a Clinical Research Project Manager for a NCI-funded informatics-driven breast cancer prevention project in Drs. Rita Kukafka and Katherine Crew's research group. The incumbent will report directly to the Principal Investigators and work in collaboration with members of the research team.

The primary scope of the work is a proposal funded by the National Cancer Institute. In this project, we have been investigating where and why, on the patient's journey from understanding their risk to discussing risk-reducing medications with their provider, there is a divergence resulting in lower uptake of breast cancer chemoprevention relative to the use of statins for cardiovascular. Using iterative equity-focused human-centered design, we conducted qualitative research on differences in the decision-making process (preventive regimens for breast cancer vs. cardiovascular disease). We previously developed and rigorously evaluated decision support tools for patients and providers. In this proposal, we are refining these decision-support tools based on a deeper understanding of chemoprevention uptake within preventive therapy for cardiovascular disease. The proposal aims are to 1) apply human-centered design to refine decision support tools for patients and providers, 2) conduct a cluster randomized trial, and 3) conduct an equity-focused evaluation of intervention implementation.

Responsibilities

1. Project Planning and Execution: Develop and execute detailed project plans, timelines, and budgets in collaboration with principal investigators and key stakeholders. Coordinate project activities, meetings, and communications to ensure timely progress and achievement of milestones while ensuring IRB compliance.
2. Clinical Trial Management: Execute a cluster randomized trial involving 200 high-risk women and 60 primary care providers (PCPs) to evaluate the effectiveness of RealRisks and BNAV compared to standard patient educational materials. Monitor participant recruitment, intervention delivery, data collection, and follow-up assessments.
3. Data Collection and Analysis: Collect, manage, and analyze quantitative and qualitative data related to chemoprevention uptake, medication beliefs, decision antecedents, decision quality, and implementation factors using appropriate research methodologies.
4. Equity-Focused Evaluation: Utilize the Consolidated Framework for Implementation Research (CFIR) to assess barriers, facilitators, and contextual factors influencing intervention implementation and sustainability across different levels (patient, clinic, health system). Conduct surveys, key informant interviews, and focus groups to gather insights.
5. Reporting and Dissemination: Prepare progress reports, presentations, and manuscripts for publication in scientific journals. Present findings at conferences, workshops, and stakeholder meetings to disseminate research outcomes and implications.
6. Assisting with project finances, including external vendor invoices and payments.
7. Work with other research staff to conduct interviews with patients and providers, code and interpret interview data, manage and engage in study tasks, including recruitment, assessments, and follow-up, preparation of documents for renewals, modifications, yearly submissions, correspondence, and audits related to IRB and annual progress reports for research grants.
8. Implementation of Decision Support Tools: Participate in ongoing human-centered design to refine and manage implementation of the RealRisks decision aid and the BNAV (Breast cancer risk NAVigation) tool for breast cancer and cardiovascular decision-making as they are integrated into the clinical trial. Conduct interviews, usability testing, and prototype evaluations with diverse groups of high-risk women, healthcare providers, and stakeholders.
9. Organizing and participating in weekly research team meetings.
10. Perform other duties as assigned.

Minimum Qualifications

Bachelor's degree or equivalent in education and experience, plus 3 years of related work experience.

Preferred Qualifications

Master's degree or equivalent with 1 year of relevant experience in research.

Other Requirements

• Excellent written and interpersonal communication, analytical, time management, and organizational skills are required.
• Ability to work collaboratively as well as independently.
• The ability to strategically problem-solve and adapt to evolving research projects as needed to optimize the effectiveness of the position.
• Proficiency with MS Word programs and familiarity with Mac and PC platforms.
• Attention to detail and the ability to exercise independent judgment within the scope of the research to meet expected goals.
• Managerial skills to oversee and train part-time staff and other research personnel and knowledge of a statistical software package and qualitative research are desirable.
• Health Insurance Portability and Accountability Act (HIPAA) training certification, Good Clinical Practice (GCP) certificate, and Conflict of Interest (COI) training certification are required upon hire.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.