Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Division of Pulmonary is seeking a Clinical Research Coordinator administratively coordinates clinical protocol implementation, typically for a single study. Will ensure efficient logistical implementation of the study activities and provide administrative support for research-related regulatory issues.

This position will primarily support the conduct of clinical research for the Johns Hopkins Sarcoidosis Center (JHSC). They will manage the daily operations of clinical trials for which the JHSC is a participating site. They will work under the supervision of the Principal Investigator (PI) to ensure adherence to study protocols and safety regulations (IRB, GCP). They will be the primary liaison between the PI, regulatory agencies, and sponsors. They will handle participant recruitment, informed consent, data collection, and study documentation. They will also provide secondary, cross-cover support to other clinical research projects conducted by the JHSC as required.

Specific Duties & Responsibilities

• Coordinate all activities of a clinical research study 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 strategies for participants for assigned study.
• 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 required activities and provide any special instructions prior to upcoming tests/exams.
• Serve as liaison to study participants.
• Assist with setup of the data collection system 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 the preparation of submissions to the Institutional Review Board (IRB).
• Liaison with IRB on administrative matters and facilitate communications with the PI.
• Conduct literature searches to provide background information.
• Obtain and maintain excellent operating knowledge of assigned clinical protocol, clinical equipment, and clinical computer systems.
• Oversee budget expenditures for study operations.
• Other duties as assigned.

In addition to the duties described above

• Along with PI, assist in recruitment process including screening records of patients in the Johns Hopkins Sarcoidosis Clinic and patients referred from external sources.
• Assist PI to initiate, modify, and submit clinical protocols for review by the JHM IRB.
• Become familiar with various data entry systems required by each clinical trial.
• Interact directly with study participants, including recruitment, consent, study visits (in person and remote), communication with participants during the clinical trial, and distributing stipends.
• Learn additional skills to support the conduct of different clinical trials as required, including but not limited to phlebotomy, performing spirometry, six-minute walk tests, and obtaining vital signs (blood pressure, heart rate, respiratory rate, temperature, oxygen saturation).

• Bachelor's Degree in a related field.
• 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.

• Related undergraduate or work experience in human subjects research.
• Phlebotomy experience.
• Experience using standard vital sign equipment.
• Proficiency with Epic.
• Previous experience with submitting protocols to an IRB.
• Previous clinical trial experience.

Classified Title: Clinical Research Coordinator
Role/Level/Range: ACRO37.5/03/CD
Starting Salary Range: $17.20 - $30.30 HRLY ($49,400 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday to Friday 8:30 am - 5 pm
FLSA Status: Non-Exempt
Location: Hybrid/Johns Hopkins Bayview
Department name: SOM DOM Pulmonary
Personnel area: School of Medicine