Research Program Leader

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Assist in clinical research for the Hematologic Malignancy and Cell Therapies Clinical Research Teams

• Carry out research, data management, administrative, and coordination tasks

• Gather, compile, document, and oversee clinical research data

• Coordinate agreements with study teams and Duke offices

• Act as an expert resource on regulatory and institutional policies and procedures

• Lead or take part in monitoring and audit training sessions while developing policies and guidelines

• Create and manage recruitment, retention, standard operating procedures (SOPs), documentation, and operational strategies

• Prepare for, coordinate, and engage in site visits

• Communicate effectively with sponsors and contract research organizations (CROs)

• Oversee protocol systems, reports, resources, and operational plans across various study teams or sites

• Identify research program objectives, gaps, constraints, needs, and milestones in collaboration with investigators

• Manage the entire research project lifecycle from initiation to closure

• Supervise project staff and modify plans and timelines based on stakeholder feedback

• Oversee program operations, budgets, staff mentoring, and training

• Ensure adherence to all relevant regulations and policies

• Provide guidance on recruitment, informed consent, study documentation, program evaluation, and data collection

• Develop and revise research proposals and manuscripts

• Represent the research program on behalf of the Principal Investigator (PI) at both internal and external meetings

• Communicate with study personnel to resolve routine protocol issues

• Pursue technical knowledge and contribute to innovation and performance enhancement

• Participate in committees and working groups

• Establish and assign team tasks to achieve study objectives

⛳️ Requirements

• Possession of a Bachelor's degree

• A minimum of four years of research experience, including roles in research, clinical settings, interaction with study populations, or program coordination

• A Master's degree may substitute for two years of related experience

• Compliance with Duke and project-specific training and certification requirements

• Understanding of regulations, policies, resources, and ethical guidelines pertaining to clinical research

• Ability to comprehend and adhere to policies, SOPs, regulations, and protocol requirements that govern clinical research

• Capacity to identify and articulate clinical trial risks and advantages

• Competence in safeguarding vulnerable research populations

• Advanced subject matter expertise in the therapeutic area or clinical research

• Proficiency in navigating Duke's clinical research processes and organizational structures

🏝️ Benefits

• Comprehensive medical and dental care programs

• Generous retirement benefits

• Family-friendly and cultural programs