Job Description

We are seeking a bright, hardworking professional to join our team and who is committed to improving women’s reproductive health. We are conducting several studies related to Reproductive Health, Bacterial Vaginosis, Sexually Transmitted Infections, and Vaginitis. The Clinical Research Coordinator II who will be an integral part of the team, helping implement these studies. Some studies may require driving to recruitment sites and then returning to Johns Hopkins Bayview to store samples and take part in additional research activities for the rest of the day. Therefore, access to a car and a valid driver’s license is required.

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 Clinical Research Coordinator II administratively coordinates clinical protocol implementation of a single complex study (e.g., inpatient 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 the 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 from appropriate participants.
• Schedule participants for multiple required activities, e.g., laboratory tests, visits, procedures, and treatment,t and resolve any schedule conflicts and ensure timely participant tracking.
• Serve as liaison to study participants.
• Assist with the setup of data collection system(s) and enter and organize data.
• Assist in coordinating study meetings.
• Participate in study meetings, 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 the 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 the 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.

In addition to the duties described above:

• Analyze qualitative research data collection.
• Use statistical analysis skills when analyzing data.
• Conduct surveys and survey analysis.

Minimum Qualifications

• Bachelor's Degree in a 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.

Classified Title: Clinical Research Coordinator II
Role/Level/Range: ACRO40/E/03/CE
Starting Salary Range: $41,080 - $73,528 ($57,200 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30am- 5pm
FLSA Status: Non-Exempt
Location: Johns Hopkins Bayview
Department name: DOM Bayview Infectious Diseases
Personnel area: School of Medicine