Research Program Coordinator

Johns Hopkins University

East Baltimore, MD

ID: 7067608
Posted: July 9, 2020
Application Deadline: Open Until Filled

Job Description

General summary/purpose:

Under the supervision of the Brain Injury OutcomeS (BIOS) Division Manager (Department of Neurology), the Research Program Coordinator will coordinate several clinical studies. Dotted report line to the individual research PIs. The position will coordinate the implementation of research protocols as well as ongoing administrative processes related to these studies; screen and enroll patients, and provide continued monitoring of these studies ensuring that all protocols are followed and status reporting, billing, and other regulatory components are performed correctly. Responsibilities include the recruitment of patients throughout the Johns Hopkins Clinical Research Network, performance of patient assessments in ED, neuro-ICU, stroke unit, rehabilitation unit, etc. Candidate will also cross-train and serve as back-up to other BIOS coordinator(s).

Specific duties & responsibilities:

Provide support and coordination for fellows and physicians during ongoing clinical studies. This would include study start up training and documentation, protocol, consent, enrollment, study completion and post study closure.
Accountable for the overall administration and outcomes for trials requiring advanced-level knowledge and skills to manage a diverse portfolio of research responsibilities.
Daily screening, recruitment, protocol adherence, schedule patient visits and assessments, as well as telephone follow up.
Write and submit to the Institutional Review Board protocols, consent forms, amendments and continuing reviews as needed.
Perform noninvasive tests, including measuring blood pressure and operating investigative diagnostic device(s).
Recruit research subjects, including screening phone calls or visits as needed.
Coordinate participation of subjects, including providing stipend, parking, and public transportation compensation for their participation.
Regular attendance at research meetings as well as providing updates on the study progress and issues related to the research.
Prepare and maintain individual participant study binders.
Adhere to FDA regulatory compliance and regulations.
Utilize good clinical research practices.
Maintain detailed working knowledge of protocols.
Maintain appropriate correspondence with the IRB. Complete and submit IRB Change in Research Reports, including adverse events, protocol deviations and protocol amendments.
Complete and submit annual IRB continuing review reports.
Ensure quality, consistency, and accuracy in the conduct of research trials.
Maintain the research data base including data entry.
Respond in a timely manner to special projects or queries related to the data.
Assist with consenting study participants and documenting the consent process.
Assist in data collection including patient contact for enrollment and follow-up.
Oversee record management to include but not limited to set up database, as well as processing systems and efficiencies for reporting purposes using Excel, Access, or similar systems
Participate in conference calls and meetings with the investigators for discussions about the projects.
Conduct all study close out related procedures including IRB termination reports

Minimum qualifications (mandatory):

BA/BS in related discipline required and some experience.

Preferred qualifications:

2 years’ experience in clinical or medical research setting strongly preferred. Knowledge of medical terminology, clinical research practices and principles (GCPs) is strongly preferred.

Experience and familiarity with EPIC and electronic data capture systems is strongly preferred. Previous experience in the clinical environment, patient recruitment and patient approach is strongly preferred.


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