The Research Program Coordinator will be responsible for the conduct of study visits with participants in study protocols designed around HIV negative and HIV positive individuals. Responsibilities will also include recruiting, enrolling and following participants in the studies.
Works closely with Principal Investigator (PI) and Research and Sponsored Projects Manager of The REACH Initiative in all aspects of study management. Communicates with study team and PI on all clinical aspects of patient management. Works with other staff members to ensure rapid data entry and high level of quality control.
Duties and Responsibilities:
Recruit, screen and enroll eligible subjects for participation in research protocols with final authorization from principal investigator and/or research team leader.
As a principal investigator designee, explain the protocol in detail and obtain informed consent from potential subjects.
Verify patient eligibility for studies with principal investigator and/or research team leader.
Obtain medical release of information from patient as needed per protocol.
Coordinate and document all aspects of subjects’ participation (including subject interviews, telephone contact with subject or friends/family of the patient; conversations with the research team and all medical providers who participate in the patients care, etc.) to ensure a comprehensive and consistent approach to the subject management on protocol.
Ensures collection of pertinent data from internal and external sources and monitors compliance with requirements of the clinical studies.
Monitor clinical course of subject’s enrolled in clinical trials, under nursing supervision, ensuring that research protocol is executed appropriately.
Participates in internal audits and assures compliance with outside monitoring.
Maintain and complete protocol specific patient records and Case Report Forms (CRF).
Maintain a good working knowledge of all assigned protocols.
Maintain confidential records of required source documentation on each assigned research subject on protocol.
Meet regularly with principal investigators, research manager and protocol team leaders to review patient participation, data accuracy and overall project progress.
Provide updates on current progress of the study as requested.
Maintain patient study calendars.
Schedule patient study appointments.
Serve as backup for research protocols (other than primary assignment) as needed.
Develop research instruments (protocol specific source documentation, lab forms, and template notes) necessary for study execution.
Control quality of source documentation and research integrity.
Detect and help solve logistical, technical and patient related problems as they pertain to protocol participation.
Coordinate laboratory specimen processing and handling with appropriate lab supervisors.
Act as liaison between The REACH Initiative and other departments as necessary for protocol implementation.
Attend ACTG / HPTN meetings to represent the research unit and grow in knowledge of data quality and the federal regulations governing clinical research.
Participate in other research initiatives as workload allows.
Assist with monthly Community Advisory Board activities.
Willingness to use personal vehicle (with reimbursement) or taxi/uber for recruitment off site
Other duties as assigned by the Research and Sponsored Projects Manager or the PI of the project.
Bachelor's degree in related discipline. Some related experience, preferably in the healthcare and clinical research field. Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Ability to perform venipuncture a plus.
Highly effective verbal and written communication skills are required as is attention to detail and the ability to complete multiple tasks on a timely basis.
Knowledge of standard computer software (e.g. Microsoft office) required.
Experience with clinical research desirable.
Experience with completion of data sets (Case Report Forms) desirable.
Ability to work well with patients and show a high degree of motivation in enrolling participants HIPAA and Research Compliance certification training relevant to human subjects’ research and other JHU classes as required.
Interpersonal skills to collaborate effectively with Principal Investigator, Senior Research Program manager, and other staff members and research participants.
Strong organizational skills.
Ability to maintain meticulous records.
A high degree of self-motivation and the ability to function both as a team member and independently.
Ability to prioritize workload on a daily and weekly basis.
Ability to work well with others to solve problems.
Ability to work under pressure and within deadlines and prioritizes multiple tasks.
Ability to maintain participant confidentiality.
Knowledge of medical terminology.
General knowledge of HIV disease helpful, but not required
Knowledge of Good Clinical Practices and FDA and HIPAA Regulations regarding Clinical Research helpful but not required.
Excellent oral and written communication skills, and organizational skills.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Ability to work with populations across ages, sexual orientations, socio-economic circumstances; a person who has worked with and/or is from the MSM community is strongly preferred.
Experience with protocol implementation and patient coordination preferred.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130... years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Baltimore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.