General DescriptionDepartment: Internal Medicine Monday-Thursday 8:00a.m.-5:30p.m. Friday 8:00a.m.-12:00p.m. I or 2 Saturday's a month 37.5 hrs.
The Sr. Research Program Supervisor will work with Principal Investigator and Director of Clinical Research Operations to implement a large, multi-center, clinical trial on the effects of moderate alcohol consumption on cardiovascular health in middle age and older adults (MACH15) at ProHealth, a Hopkins-affiliated clinical research. This project is expected to begin recruitment of participants by June 2017, with a ramp up (preparation) phase of 4 months (including local IRB submission and interviewing and hiring of staff). This position has a primary duty and responsibility to implement this large randomized clinical trial. Other duties include assisting with implementing other studies conducted at ProHealth. He/she functions as a critical member of the research team, primarily overseeing the administrative and scientific implementation of the main research study as well as ancillary studies. This position is responsible for recruiting and supervising recruiters, interventionists, data collectors, and at times graduate students. This position must demonstrate problem-solving skills as they relate to participant care activities and provides guidance for and acts as a role model for all staff on the research project.
Duties and Responsibilities:
Responsible for the implementation of MACH15 at the Hopkins site (one of 7 Vanguard Centers starting out and testing best practices for recruitment, delivery of the intervention, and adherence). This includes implementing and integrating every aspect of the study research at ProHealth, developing a local manual of procedures, coordinating the delivery of the intervention to participants, and creating participant materials and incentives. Maintain an excellent working knowledge of the trial protocol. Responsible for collaborating with other clinical centers and data coordinating centers. Establishes and maintains a confidential and secured data management system that integrates data from study participants and lab, and allows tracking of participants. Establishes and maintains a system of storing charts of the participants. Prepares relevant regulatory documents and progress reports for ongoing research. Responsible for coordinating serious adverse event reporting with the investigators and the coordinating unit to insure prompt reporting to IRB and DSMB. Establish, communicate, and maintain working relationship ProHealth staff regarding data access and attainment. Directly coordinates individual study activities when needed including preparation of research protocols, standard operating procedures, data collection tools, IRB, coordination of participant recruitment, enrollment, data collection, retention and tracking as well as data management. Coordinates recruitment and data collection including screening for eligibility, questionnaires, blood pressure, height, weight, and blood draws. Conducts participant interviews; assist in screening and assessment of potential study participants including randomization of study participants. Conducts follow up assessments appropriate to study protocol. Ensures participant information data is collected and recorded as directed by the data coordinating center of the study and according to best practices. Oversees monitoring of progress of the delivery of the intervention and data collection and performs quality control activities.
Gains/maintains expertise, serves as resource as needed for staff on all data collection measures including questionnaires, weight, height, waist circumference, blood pressure, and laboratory measures and procedures (e.g. aliquoting). Ensures training and certification occurs and quality data are collected. Provides skill development and training on intervention and data collection procedures to rest of research team through in-service programs to enhance staff and investigator knowledge level and to ensure standardization of intervention delivery. Works with PI and independently to identify new or changing staff needs and respond with posting of job requisitions to address needs, hiring of staff and ongoing assessment of staff. Provides support and guidance to research staff to facilitate ongoing progress toward project goals and to ensure quality of work. Responsible for ensuring the successful attainment of study(s) goals within timelines. Makes independent decisions regarding project planning and implementation. Responsible for daily expenditures of study and reporting and reconciliation of both Procurement and Petty Cash accounts. Meets regularly with research team for review of data accuracy and overall progress. Accountable for all developed internship, summer student and casual employee training and documentation. Demonstrates problem-solving skills as they relate to participant care activities, and acts as a role model for all staff. Integrates, as appropriate, MACH15 research activities with other research conducted at ProHealth Supervises staff and completes performance reviews in compliance with prevailing JHU policy Leads team meetings when PI is not present. Participates in staff, supervisor and investigators' meetings. Assists Principal Investigator and Director of Clinical Research Operations of ProHealth on other projects at the clinical center and performs other duties as assigned.