Consultations
Bioinformatics

Ruslan Sadreyev, Ph.D
Relevant Units, Centers, and Support Services
Biostatistics

Andrea Foulkes, ScD
Relevant Units, Centers, and Support Services
Biostatistics for K Awardees

Hang Lee, PhD
Relevant Units, Centers, and Support Services
Clinical Research Education

Jamie Quinkert, PhD
Relevant Units, Centers, and Support Services
Community Outreach and Access

Julie H. Levison, MD
Relevant Units, Centers, and Support Services
EHR Data Acquisition
To start working with the DCR, download the analysis plan template, example, and example appendix before requesting your consultation.

James B. Meigs, MD, MPH
Relevant Units, Centers, and Support Services
Finding Research Collaborators

Takara Stanley, MD
Relevant Units, Centers, and Support Services
Grant Writing (non-K)

David M. Nathan, MD

Takara Stanley, MD
K Grant Writing

Karen Miller, MD
Relevant Units, Centers, and Support Services
Manuscript Proofing Support Service

Jamie Quinkert, PhD

Ava Truant
Relevant Units, Centers, and Support Services
Munn Center for Nursing Research

Jennifer Cahill, PhD, RN
Relevant Units, Centers, and Support Services
Nursing Research

Kathy Hall, NP
Relevant Units, Centers, and Support Services
Omics Research

Jordan W. Smoller, MD, ScD
Relevant Units, Centers, and Support Services
Participant Recruitment and Retention
The Participant Recruitment and Retention Unit (PRRU) helps study teams enhance participant recruitment and retention efficiency and effectiveness in clinical trials. Faculty provide coaching, training, and guidance to study teams to address barriers to participation, ensuring a broader representation of participants and maintaining participant engagement throughout the study. The unit also provides expert instructional design support in developing multimedia tools and direct, hands-on study coordinator support for screening and recruiting participants.

Andrew Nierenberg, MD

Vidya Iyer, MBBS
Relevant Units, Centers, and Support Services
Patient-Centered Outcomes Research

Andrew Nierenberg, MD
Relevant Units, Centers, and Support Services
Philanthropy Education

Lee Cohen, MD
Relevant Units, Centers, and Support Services
Project Management
Project Managers (PMs) provide administrative support throughout the clinical trial continuum from study start-up to study close-out.
Project Managers assist investigators in administrative, regulatory, financial, study and data monitoring, data management, and study conduct activities, following ICH GCP guidelines, FDA, sponsor, and MGB policies and regulations.
For any additional Project Management service not listed here, please email dcrccre@partners.org
A comprehensive list of services includes:
- Protocol feasibility assessment
- Protocol development and writing
- Administrative assistance with FDA IND/IDE application submissions, including single IND or Expanded Access Protocol (EAP) submissions
- IRB submissions: initial study submission, responding to queries and tracking the application status, continuing review, and protocol amendment submissions
- Contracting with sponsors
- Budget management
- Data Management: Case Report Forms build, REDCap database build and validation, data abstraction and entry
- Safety reporting
- Navigating the clinical trial review and approval process at MGB
- Training and onboarding new study staff
- Regulatory compliance checks: Preparing for internal and external audits, QI/QA audits, development of SOPs, Corrective and Preventive Action Plans (CAPA)
- Study coordinator services (pre-screening, screening, recruitment, study visit coordination, and data entry).

Francine J. Molay, MS

Rupali Ranade, MBBS
Relevant Units, Centers, and Support Services
Qualitative and Mixed Methods Research

Elyse Park, PhD, MPH
Relevant Units, Centers, and Support Services
Research Design
To start working with the DCR, download the analysis plan template, example, and example appendix before requesting your consultation.

James B. Meigs, MD, MPH
Relevant Units, Centers, and Support Services
Research Ethics
Relevant Units, Centers, and Support Services
Survey Research

Esteban Barreto, PhD
Relevant Units, Centers, and Support Services
TCRC: Nutrition Research

Jane Hubbard, MS
Relevant Units, Centers, and Support Services
Translational Medicine

Mason W. Freeman, MD
Relevant Units, Centers, and Support Services
Virtual Drop-In Sessions for CRCs

Francine J. Molay, MS
