Clinical Research Coordinator II

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. We are seeking a Clinical Research Coordinator II who will administratively coordinate clinical protocol implementation of a single complex study (e.g., in-patient study, translational research involving clinics and labs, participant accrual at multiple sites, study for which Hopkins is a coordinating center) or multiple studies. Will ensure efficient logistical implementation of study activities and provide administrative support for research-related regulatory issues.

Specific Duties & Responsibilities

• Coordinate all activities of a complex clinical research study or multiple studies to ensure adherence to protocol and validity of findings.
• Participate in clinical study start-up meetings.
• Assist research nurses, study coordinators, principal investigators and other study personnel in executing protocol-related activities.
• Explain the study background and rationale for the research to potential and current participants.
• Contribute to the development of recruitment strategy for participants for one or more assigned studies.
• Implement a variety of techniques for recruitment as appropriate, e.g., print and web-based advertisements, contact referring physicians, participate in community events, etc.
• Independently conduct the consenting process or ensure consent is obtained on appropriate participants.
• Schedule participants for multiple required activities e.g., laboratory tests, visits, procedures, and treatment and resolve any schedule conflicts and ensure timely participant tracking.
• Works directly with the clinical staff (MDs, NPs, nurses, and social workers) to ensure efficient and appropriate care for research participants.
• Coordinates frequently with research partners at outside institutions on patient scheduling and data sharing.
• Conducts research neurocognitive assessments, including the administering of the California Verbal Learning Test (CVLT), NIH Toolbox, NEPSY-II/DKEFS, and Wechsler Intelligence Scale (WPPSI-IV, WISC-V, and WAIS-IV).
• Ensures distribution of research materials, including parent and self-report questionnaires, is completed according to protocol timelines.
• Serve as liaison to study participants
• Assist with setup of data collection system(s) and enter and organize data.
• Assist in coordinating study meetings.
• Participate in study meetings and provide updates on protocol implementation status and make recommendations on operational issues.
• Assist with preparation of submissions to the Institutional Review Board (IRB)
• Liaison with IRB on administrative matters and facilitate communications with the PI(s).
• Track/maintain regulatory documentation and clinical care documentation provided to increase regulatory compliance.
• Serve as a resource for clinicians involved in the study regarding protocol requirements.
• Conduct literature searches to provide background information. Abstract, index, and analyze information.
• Obtain required samples and collaborate with internal and external entities for studies involving procurement and processing of clinical samples
• Obtain and maintain excellent operating knowledge of assigned clinical protocols, clinical equipment, and clinical computer systems.
• Oversee budget expenditures for study operations.
• Ensure adequate study supplies are ordered and maintained, e.g., shipping, laboratory, office, specimen handling, etc.
• May train and/or oversee other non-exempt study staff.
• When applicable, assists with the creation of new research protocols. Works with the Principal Investigator and other staff to submit applications to the IRB and other relevant agencies. Creates and presents material educating all relevant parties on new protocols. Creates databases and trackers to organize new data. Assists with the creation of workflows to ensure new protocols are managed and carried out efficiently.
• May assist in or, if interested, spearhead the creation of abstracts to be submitted to relevant conferences. With the help of biostatisticians and the Principal Investigator, analyze data and create materials on results. If applicable, present research data at conferences.
• Other duties as assigned.
  
  

Minimum Qualifications

• Bachelor's Degree in related field.
• One year of related experience.
• Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
  
  

Preferred Qualifications

• Ability to conduct neurocognitive assessments using the following tests: California Verbal Learning Test (CVLT), NIH Toolbox, NEPSY-II/DKEFS, and Wechsler Intelligence Scale (WPPSI-IV, WISC-V, and WAIS-IV).
• Will be trained if has no prior skill.
  
  

Technical Skills & Expected Level Of Proficiency

• Budget Management - Developing
• Clinical Research Participant Recruitment - Developing
• Clinical Research Knowledge - Developing
• Clinical Trial Management System - Developing
• Data Collection and Reporting - Developing
• Good Clinical Practices - Developing
• Information Gathering - Developing
• Interpersonal Skills - Developing
• Project Coordination - Developing
• Regulatory Compliance - Developing
  
  

The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.

Classified Title: Clinical Research Coordinator II

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

Starting Salary Range: $19.75 - $35.35 HRLY ($55,000 targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: M-F, 8:30am-5:00pm

FLSA Status: Non-Exempt

Location: Sibley Memorial Hospital

Department name: SOM Rad Onc Clinical Trials Group

Personnel area: School of Medicine