John Hopkins University

We are seeking a Sr Research Program Coordinator who is responsible for coordinating and managing clinical research activities for Dr. Marlis Gonzalez Fernandez. They will oversee all facets of research activities, including patient recruitment and scheduling, data collection and management, specimen collection, handling and processing, compliance with IRB regulations and communicating with team members on the status of projects. The Sr. Research Program Coordinator II will act as primary liaison between principal investigator, School of Medicine, Research Administration, Clinical Research Units, funding agencies and other study related organizations.

Specific Duties and Responsibilities

• Assist principal investigators with multiple clinical research projects. Work on clinical studies requiring a high level of knowledge, coordination and data abstraction.
• Assist clinicians with patient screening, consenting and verification of patient eligibility for studies.
• Be responsible for organization and completeness of clinical research data, including data entry, maintenance of records and accuracy of the data.
• Design and compile materials and standard operating procedures which aid physicians and other staff in complying with protocol requirements.
• Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies.
• Collect patient source documents and case report forms for analyzing patient data.
• Act as primary contact for study participants, which may include scheduling, confirm appointments, and escorting/directing to various locations on campus.
• Coordinate the collection and documentation of patient information for research purposes.
• Organize and create clinical research charts to be reviewed by regulatory agencies.
• Maintain a research database of patients enrolled in clinical trials.
• Participate in and or organize community events to increase public awareness.

Regulatory Compliance

• Responsible for Institutional Review Board (IRB) submission, verification and maintenance of protocol.
• specific information. Prepare and submit annual renewal requests, amendments and safety reports according to IRB requirements.
• Maintain regulatory binders per protocols.
• Document adverse events and protocol deviations.
• Complete and maintain required certifications / training, e.g., CITI or DOT/IATA certification.

Data Management

• Responsible for maintaining and promptly updating online Clinical Research Management System.
• Assist with preparation of data for reports and presentations.
• Design and implement procedural adjustments to increase accuracy and efficiency of data collection and entry process.
• Perform quality checks on data entry.
• Ensure accuracy and timeliness of data collection. Interact regularly and helps facilitate the completion of work with members of the research team regarding data management and the status and progress of ongoing studies. Assist with writing manuscripts and abstracts for publication.
• Assist with development of grants, progress reports and study protocols.

Research Program Oversight.

• Meet regularly with Principal Investigators to review and discuss research data and overall study progress.
• Work with the Center Directors and/or study sponsors on problem recognition/resolution, data accuracy and regulatory documentations as required by study sponsors.
• Prepare for and participates in monitoring visits and audits.
• Conduct periodic audits under the direction of the Program Coordinator and/or PI.

Financial Management

• Keep records of expenditures and work with budget analysts to ensure accurate and prompt reporting of
• study financials.
• Create clinical research budgets, oversee account activities, prepare invoices.
• Supervise
• Depending on needs, may participate in hiring and oversight of other personnel such as study coordinators or temporary workers.
• May mentor or assist trainees.

Minimum Qualifications

• Bachelor's Degree in related discipline.
• Three years related experience.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond HS Diploma/Graduation Equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Master's Degree.
• Experience using EPIC.
• Experience developing REDCap as a database to track and monitor study data.
• Supervisory experience and basic statistical knowledge.
• Familiarity with Johns Hopkins clinical data structures advantageous.

Classified Title: Sr. Research Program Coordinator

Role/Level/Range: ACRP/03/MB

Starting Salary Range: $19.85 - $35.00 HRLY ($35.00 HRLY targeted; Commensurate w/exp.)

Employee group: Casual / On Call

Schedule: M-F, 8a-430p

FLSA Status: Exempt

Location: Hybrid/School of Medicine Campus

Department name: SOM PMR Physical Med and Rehabilitation

Personnel area: School of Medicine