Research - Laboratory/Non-Laboratory, Staff/Administrative
The Sr. Research Program Supervisor will be responsible for the conduct of study protocols by the research team. Responsibilities will also include managing staffs, recruiting, enrolling and following participants in the studies, as well as research-related work. Works closely with Principal Investigator (PI) 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.
Specific Duties & Responsibilities
Manage research staff members (recruitment, performance appraisal, feedback, discipline concerns, separations).
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 study and other departments as necessary for protocol implementation
Attend study 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
Willingness to use personal vehicle 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.
Three years of related experience required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Phlebotomy training, and demonstrated proficiency.
* JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the 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. *
Related Master's preferred. Some supervisory experience strongly preferred.
Special Knowledge, Skills, and Abilities
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
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 protocol implementation and patient coordination preferred
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
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
Classified Title: Sr. Research Program Supervisor Working Title: Sr. Research Program Supervisor Role/Level/Range: ACRP/03/MC Starting Salary Range: $45,195 - $62,225; Commensurate with experience Employee group: Full Time Schedule: Monday - Friday, 8:30am - 5:00pm / 37.5 hours per week Exempt Status: Exempt Location: 06-MD:School of Nursing Department name: 60009277-Research Administration Personnel area: School of Nursing
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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