Research Program Coodinator - Baltimore, United States - InsideHigherEd

Description

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: $ $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