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We are seeking a Research Program Coordinator to conduct research trials for IMPAACT, ATN, and other government funded agencies and pharmaceutical companies. The candidate will work collaboratively with a multidisciplinary health care/research team to promote quality and excellence of care, optimize team performance and achieve divisional clinical, research and organizational goals and outcomes.

Specific Duties & Responsibilities

Project Management (75%)

Pre-study

• Anticipates research requirements for designated patient populations.

• With guidance, reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintenance of subject safety.

• Lists & clarifies concerns and questions about new protocols with PI and sponsor.

• Evaluates the impact on and availability of resources for assigned clinical trials.

• Reviews prospective reimbursement analysis (PRA) as appropriate.

Pre-initiation

• As appropriate & with guidance, prepares & submits application and consent forms to the IRB.

• With guidance, prepares other forms required for study initiation (pre-printed orders, eligibility checklists, lab requisitions, etc.).

• Determines that IRB approval has been received prior to initiation of research activity.

• Participates in study initiation meetings.

• Prepares space for study-related equipment & supplies.

Recruitment & Enrollment

• Ensures initial & ongoing eligibility of all subjects for assigned research studies,

• Screens potential research subjects for participation in clinical trials (including Review of medical history, concomitant meds, pathology, other relevant documents)

• Evaluates ongoing eligibility of research subjects’ participation in clinical trials; collaborates with Principal Investigator to obtain exemptions as appropriate.

• Abstracts data from a variety of sources to complete pre-study work-up.

• Demonstrates understanding of the informed consent process.

• With guidance & as appropriate, obtains informed consent from research subjects.

• As appropriate, documents obtaining of informed consent in medical record.

• Registers research subjects per sponsor guidelines.

• In conjunction with PI, monitors protocol enrollment goals.

• Demonstrates knowledge of protocol endpoint definitions.

• In collaboration with healthcare team, evaluates potential subjects for research participation.

Data Collection/Document Maintenance

• Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials.

• Obtains & ensures proper distribution of required pharmacokinetic & tissue samples.

• Schedules, performs, and/or monitors procedures & tests per protocol requirements.

• Ensures correct documentation of clinical study in medical record and appropriate protocol documents. Schedules visits, tests & procedures for patients entered in clinical trials to ensure results are available in a timely manner.

• Maintains clinical research management system (CRMS) data base for enrollment.

• Reviews protocol amendments as required.

• Develops procedure and collection forms for pharmacokinetic sampling.

• With guidance & as dictated by research protocol, obtains required data through chart review, telephone communication, subject interview & assessment.

• Coordinates with data managers to ensure delivery of trial data for inclusion into study files.

• As appropriate, orders required medical equipment & supplies.

• Maintains working knowledge of institutional information systems for correctly scheduling clinical tests & procedures and extracting data.

• Achieves and maintains a working knowledge of computer software specific to department, including word processing, e-mail & internet functions.

• Aware of & knowledgeable about departmental Standard Operating Procedures.

Quality Assurance :

• Recognizes and documents adverse events per protocol & ensures reporting to appropriate study & regulatory personnel.

• Initiates adverse event reports and ensures proper and timely distribution to sponsor and IRB.

• Ensures that appropriate team members grade identified toxicities per specified grading tables or protocol-specific criteria.

• Attends staff meetings to review study progress.

• In collaboration with other members of the research team, prepares for and responds to study audits.

• Assists in completion of annual periodic review of data for reporting to IRB, protocol sponsors, & cooperative groups.

• Documents written & verbal communication with study contacts.

• Communicates effectively with subject & family of active and prospective study participants.

• Communicates effectively with members of the health care and research teams.

• Meets regularly with other members of the research team to review protocol progress and data collection.

• Attains proficiency in Web-based communication.

• Demonstrates understanding of the rules for advertising for subject participation, where appropriate.

Education (10%)

Patient/Family Education

• Ensures development and/or availability of appropriate protocol- and/or treatment-specific patient education materials.

• Determines effectiveness of patient/family education & modifies the education plan to most effectively address patient/family needs.

Staff Education

• Identifies staff learning needs, including those based on requirements specific to designated research protocols.

• Ensures development & availability of appropriate staff education materials.

• Provides staff education related to assigned clinical trials (i.e., in-services).

• Attends and participates in in-service and external trainings, workshops, conferences, and other relevant and/or required programs for professional growth and development.

Quality Management Activities (15%)

• Reviews source documents and CRFS completed by other study team members for thoroughness and accuracy.

• Provides feedback and ensures that appropriate corrections are made.

Minimum Qualifications

• Bachelor's Degree in related discipline.

• Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Research experience preferred.

Classified Title: Research Program Coordinator

Role/Level/Range: ACRO40/E/03/CD

Starting Salary Range: $17.00 - $30.00 HRLY ($22.06 HRLY targeted; Commensurate with experience)

Employee group: Casual / On Call

Schedule: M-F; up to 20 hours per week

Exempt Status: Non-Exempt

Location: Hybrid/School of Nursing

Department name: ​​​​​​​SOM Ped Infectious Disease

Personnel area: School of Medicine

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.