The Sr. Research Program Coordinator will have clinical trial experience, particularly with managing pragmatic clinical trials that interface with clinical care and the electronic health record. Along with Dr. Bennett, the Sr. Research Program Coordinator will manage all operations of the study at the Johns Hopkins University Welch Center and in participating clinical practices.
- The coordinator will be responsible for day-to-day implementation of the project and will work closely with Dr. Bennett (PI) and the team of co-investigators on all aspects of the study, particularly with IRB protocols and study policies, updating protocols and procedures, assisting with screening/recruitment, conducting randomization visits, supervising and carrying out the data collection in clinics.
- The coordinator will serve to manage the project and team. The coordinator will assist with organizing, planning study meetings and tracking major action items for all working groups (recruitment/retention, data mgmt./analysis, etc.). The coordinator will assist with reports to each of the study work groups (e.g. data quality reports), the Safety Officer, the IRB and NIH-NIDDK (i.e. NIH and IRB progress reports).
- The coordinator will work closely across the 7 prenatal clinical sites and be present at their practice meetings to ensure integration of the protocol into prenatal care practices.
- The coordinator will also assist with training and supervising the research assistants with day to day activities, especially management of the 2 Facebook pages for the study.
- The coordinator will implement all retention strategies – gift card management, birthday and birth cards and other gifts, as well as reminder calls and texts—to ensure high rates of followup and survey completion.
About the research study:
- Healthy for 2/Healthy for U (H42/H4U) Trial is a NIH-NIDDK-funded pragmatic randomized controlled trial to assess the effect of remotely delivered health coaching on pregnancy weight gain. The intervention will be integrated into prenatal care at JHH, JHMBC and JHCP clinical sites.
- The H42/H4U intervention has 4 main components:
- Health coaching remote communication – i.e. phone calls, MyChart or email or text messages or video calls— paced with gestational week and prenatal visits
- Interactive web-based platform with learning activities (focused on healthy diet, physical activity and wellness), behavioral goal setting functionality, tools for communicating with health coaches (via text, email and video)
- Weight/diet/physical mobile activity trackers
- Referrals to community resources
- Data collection is predominantly from electronic surveys and through abstraction of the electronic medical record, with some in person collection in the postpartum period, and for a height assessment at one time point in pregnancy,
- The main outcome is total gestational weight gain. Other outcomes are postpartum weight retention, gestational diabetes and diet and exercise changes.
Specific Duties & Responsibilities
The Sr. Research Program Coordinator is responsible for helping to develop, coordinate, implement and manage all aspects of the trial:
- Manages trial protocol in the IRB, include changes in research and continuing reviews and protocol events.
- Organizes, coordinates and runs (along with the study PI) the weekly team “lab” meetings. Maintains an organization system to track and manage study-related day to day and week to week action items.
- Creates, maintains and updates manuals of procedures for recruitment, retention, data collection and data analysis; assists with manuals of procedures for intervention.
- Assists with management of safety reporting to NIH, IRB and the Safety Officer
- Assists with other reports including recruitment, retention, data quality reports.
- Coordinates communication, meetings and action items for the Work Groups – Recruitment and Retention, Intervention, Data Mgmt/Data Analysis—and well as the monthly Oversight meeting.
- Assists with Aim 2 focused on the conduct of interviews with stakeholders before and after the intervention.
- Organizes the Stakeholder Advisory Group’s meetings and coordinates their agendas and followup.
- Works as the liaison/“face of the study” (along with the Coach Managers), to be present at clinic staff meetings and rotate ‘appearances’ at the clinical sites for intervention and coordinates intervention logistics in close collaboration with them, including intervention timing, space and staff needs, as well as data collection.
- Helps to train and supervise the data collectors; assists with data collection when needed.
- Provides “refresher” trainings on assessment of standard height and weight in prenatal and pediatric practices.
- Develops quality assessment metrics for data collectors and helps to organize their time at sites and with home or pediatric visits
- Develops and implements quality control procedures for recruitment and data collection.
- Recognizes safety concerns among participants and assists with management and coordination with research nurse, co-I’s, providers and study PI.
- Assists in the develop of retention strategies for the Control group, particularly newsletters, birthday cards.
- Supervises research assistants in their day to day activities, particularly on creating and updating content for the 2 study Facebook pages.
- Provides other duties as assigned.