The Senior Research Coordinator is responsible for the coordination and implementation of assigned clinical trials within the Huntington Disease Center, under the supervision of study PIs.
Specific Duties & Responsibilities:
Provides overall management for research trials at the Center acting as Primary or support coordinator as assigned.
Anticipates research requirements for designated patient populations. May collaborate in development and writing of protocols, consent forms and investigational drug data sheet as appropriate. Applies knowledge of study design to evaluate new protocols. Works closely with all PIs to help them recruit and manage all study patients. Ensures correct documentation of clinical trials. Schedule, coordinate and conduct participant visits in conjunction with other study investigators and research staff, including arrangements for participant transportation. Obtain and record subject data, including detailed health history and data, vital signs, EKGs, symptom rating scales, cognitive assessments, and side effect evaluations. Monitor participants, including answering calls and emails about concerns that may arise about the study, involving the study PI as appropriate.
With Principal and Sub-Investigators, ensures initial and ongoing eligibility of all subjects for assigned research studies. Ascertains medical history and assesses subjects for inclusion/ exclusion criteria. Assesses subjects for adverse events and their clinical significance. Documents all aspects of medical and concomitant issues and drug and other intake completely. Lists and clarifies concerns and questions about new protocols with PI and/or sponsor. Collaborates in development of study tools including data collection forms, eligibility checklists, pre-printed orders, etc. Helps to review prospective reimbursement analysis (PRA) as appropriate. Helps to create study CRFs as needed, coordinates with data managers to ensure delivery of trial data into study files. Accepts receipt of Investigational Product, and monitors storage and use during trial. Prepares drug data sheets for pharmacy and assures submission of the same to CRO/IRB for assigned protocols as appropriate. Draft and edit study protocols with supervision by PI, contribute to protocol revisions, and recruitment materials, including preparing, submitting, and updating documents for IRBs, DSMBs, study monitors, and central coordinating centers. Perform standard data analysis, including preparation of graphs and tables for grants, annual reports and presentations. Assist with preparation of grant applications, presentations and manuscripts. Assist budget analyst in maintaining accurate accounting of study costs, revenues, and financial projections. Initiate, schedule and organize meetings with study staff or representatives of monitoring organizations as necessary.
Assures that all protocol elements of a trial are in place before opening to accrual. Creates eligibility checklist for assigned protocols. Collaborates in the development of recruitment strategies to ensure patient accrual within protocol time frames. Ensures collection of pertinent data from internal and external sources and monitors compliance with requirements of assigned clinical trials. With Principal and Sub-Investigators, assist in determining adverse event causality and relationship to study drug/procedure. Records and documents protocol deviations.
Demonstrates excellent ability to manage multiple projects at different stages of the clinical research process. Demonstrates ability to integrate new clinical trials with current research activity. Develops strong relationships with participating subjects and their caregivers. Strong organizational problem solving and communication skills. Designs/coordinates educational programs for patients and families relevant to protocols as needed. Provides ongoing education to patients and families regarding pertinent clinical trial and clinical management issues. Monitors subject compliance with requirements of study protocol. Collaborates with health care team to coordinate and facilitate protocol requirements for assigned clinical trials to evaluate subject responses to interventions outlined in study protocol. Attends and participates internal and external training, workshops, conference and other relevant programs for professional growth and development.
Develops understanding of the role of the involved Clinical Research Organizations (CROs) and their representative Clinical Research Associates (CRAs). Works with CROs and CRAs to fulfill sponsor expectations. Works productively with monitors on site. Interactions with Johns Hopkins Institutional Review Board required, and knowledge of entering e–irb protocols and updates and interacting with IRB staff necessary. Supervises research coordinators and students as needed.
Minimum Qualifications (mandatory):
Education: Bachelor’s degree in a related discipline required.
Experience: 3 years related experience.
Preferred qualifications: Master’s Degree preferred. Research and/or experience with multisite clinical trials of drugs is highly desired.
Special Knowledge, Skills, and Abilities:
Ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of the patients served.
Ability to get along with a wide range of people, including those affected by neurological disease.
Highly effective verbal and written communication skills are required.
Ability to obtain basic vital signs assessment necessary.
Phlebotomy and CPR experience preferred.
Comfort with observing and assisting the Principal and the Sub-Investigators with invasive procedures is required (appropriate training provided).
Any Specific Physical Requirements for the Job:
Able to assist patients with mobility difficulties on and off the weight scale, push them in the wheelchair as needed, and offer light assistance with walking.
1-3 research coordinators and/or students
Classified Title: Sr. Research Program Coordinator Working Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920-$53,520 Employee group: Full Time Schedule: Monday-Friday/8:30am-5:00pm/37.5 hours Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003302-SOM Psy Neurobiology Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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