Position Title: Research Coordinator
Reports To: Senior Scientific Officer (Principal Investigator)
Effort: Part-time, listed as 50% FTE (for 22 months) – Average of 20 hours per week
Location: Remote
Summary:
The Research Coordinator (RC) will oversee day-to-day implementation of the NIH/NCI-funded Phase II clinical trial evaluating the EnergyPoints app for managing fatigue and sleep disturbances in cancer survivors. This role is responsible for coordinating the progression of each study participant (SP) through the study including enrollment, consent, onboarding, scheduling, follow-up, data collection, and analysis. The RC will help to ensure IRB compliance in all aspects of the study. As a pivotal member of the research team, the Research Coordinator will liaise with scientific leadership, software developers, clinicians, and community partners to ensure the successful execution of a decentralized clinical trial. Strong project management and communication skills are essential.
Key Responsibilities:
Participant Management
- Serve as the primary contact for study participants throughout the enrollment, intervention, and data collection process.
- Lead the informed consent process and verify eligibility according to IRB-approved protocols.
- Instruct the participants on the study expectations and use of the app and Fitbit;
- Answer any correspondence (calls, texts, emails) from any SP requesting technical or other assistance; Track participant progress through intervention and data collection timelines, providing reminders and support to ensure adherence as outlined in the standard operating procedures.
- Review adverse event screening and alert reports and triage response and communication.
- Conduct the exit interviews.
Study Implementation
- Assist in finalizing study workflows, standard operating procedures, and digital onboarding protocols.
- Collaborate in design of the REDCap study support platform, ensuring integration with the EnergyPoints app and REDCap surveys.
- Maintain study calendars and track protocol fidelity.
Regulatory and Ethical Compliance
- Support the Principal Investigators in managing IRB submissions, reports, renewals, amendments,
- Collaborate in documentation for audits, annual NIH reports, and clinicaltrials.gov updates.
- Ensure all participant communications are HIPAA compliant and appropriately logged.
Data Collection and Reporting
- Monitor real-time data collection in REDCap and work with the research team to resolve missing or incomplete entries.
- Collaborate with the Data Manager and Principal Investigators to prepare data summaries for interim analysis, grant reporting, and publication.
- Participate in the Qualitative Data Analysis Team; Support qualitative data collection and analysis.
- Contribute to publications.
Team Coordination and Communication
- Prepare reports for weekly team meetings. Coordinate communication across members of the research team to ensure alignment with the work plan.
- Maintain documentation of study activities and workflows
Qualifications:
- Bachelor’s degree in health sciences, public health, psychology, nursing, or a related field; Master’s degree preferred
- Experience in the design and implementation of human subjects’ research, including obtaining informed consent.
- Experience coordinating research studies or clinical trials preferred; oncology or behavioral health experience preferred
- Knowledge of research methods, research tools, and principles of research design, data analysis, and statistics
- Familiarity with IRB processes, NIH-funded research, and human subjects’ protection. Training in the Responsible conduct of research preferred.
- Proficiency in Microsoft Office suite, Zoom, and relevant digital research tools. REDCap proficiency preferred.
- Excellent written and verbal communication skills
- Strong organizational skills and the ability to work independently while managing multiple components of the research process
- Ability to work collaboratively with diverse stakeholders and uphold high ethical and professional standards
Additional Notes:
This position is grant-funded through a Phase II NIH/NCI Small Business Innovation Research (SBIR) award and contingent upon continued funding. The position is part-time and averages approximately 20 hours/week; hours may vary from week to week. There will be two RCs who will share responsibilities to ensure adequate coverage.
Start Date: Rolling, with immediate availability preferred
Duration: Through the end of the grant period (anticipated 22 months), with potential extension based on funding and performance.
Salary Range: $50 to $57/per hour
