Research Program Coordinator - Baltimore, United States - Johns Hopkins University

Description

We are seeking a
_Research Program Coordinator_ who will be responsible for coordinating clinical research activities for the Johns Hopkins Magnetic Resonance (MR) division.

The coordinator 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 individual will act as primary liaison between principal investigator, School of Medicine, Research Administration, and other study related organizations.

• Be familiar with good clinical practice guidelines and knowledge of sponsor and FDA guidelines.
• Works with the principal investigator (PI), or surrogate for the PI such as a research assistant to maintain current subcontracts for other universities and participating centers. Prepare annual reports to the NIH and subcontractors for multiple grants and contracts.
• Works under supervision and direction of Departmental Sr. Research Program Manager to conduct and manage research study activities and address divisional research needs.
• Coordinates with contacts at the IRB office to expedite proposals, if applicable.
• Responsible for the organization, entry, maintenance and accuracy of patient clinical research data.
• Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus.
• Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies.
• Comply fully with institutional and external clinical research requisites.
• Responsible for Institutional Review Board (IRB) application submissions which include annual summary reports, protocol amendments and adverse events to IRB. Ensures that staff members completing this task are properly trained.
• Participates with the PI and other senior level management staff in the overall planning for the research team.
• Complete IRB procedures, study procedures, CRMS, consenting and consent documentation.
• Will screen, consent and enroll participants. Responsible for participants# visits, collection of data, record maintenance, and regulatory documentation.
• Schedule patients# appointments and follow-up visits/phone calls at the appropriate time to assure completion of protocol requirements. This may require coordination of multiple appointments and centers.
• Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies.
• Enter orders and send required documents in/to EPIC.
• Maintain and promptly update online Clinical Research Management System for each study protocol.
• Oversee and conduct recruitment, recruitment materials, flyers and other advertisements in physicians office, website and other venues as determined by the study team- in order to enroll eligible patients.
• Prepare and submit advertisement and recruitment plan to IRB, including flyers and handouts. Prepare and implement phone-screening form.
• Maintain compensation records for research participants.
• Defines information and plans required to accomplish goals of the study in coordination with PI.
• Creates processes and new systems to ensure high level of operation and successful implementation of research projects.
• Maintains detailed knowledge of all assigned protocols and maintains regulatory binder for each.
• Will work on several assigned research protocols simultaneously. Research protocols will vary in length, complexity, procedures required, number of subjects to enroll, investigator and site. Will work under supervision of Sr. Research Manager.
• Demonstrates understanding and sensitivity to diversity. Considers cultural and linguistic differences that may impact patient and staff experiences and makes appropriate accommodations/recommendations to ensure smooth operation of the Lupus Center
• Implements interventions to enhance participant retention, as needed.
• Designs and creates data collection forms, as needed.
• Applies a working knowledge of principles of ethical conduct of research.
• Maintains research charts, source documents and other relevant administrative information for each subject.
• Coordinate same-day blood shipments for cohort studies to central lab for processing or as needed.
• Collaborate with faculty and staff in maintenance and tracking of a central biorepository of samples.
• Verifies patient eligibility for studies through patient history and medical record receipt and review, where necessary, in accordance with protocol requirements.
• Meets regularly with the PI and team to review protocol status and any related updates.
• Initiate problem resolution regarding participant flow, recruitment initiatives, and staffing issues.
• Maintain existing database files and oversee development of new study-appropriate databases as needed under supervision of senior staff.
• Develop and maintain a library of case report forms for electronic data capture to support multiple research protocols for randomized clinical trials and cohort studies as directed.
• Maintain study data and supporting documents in JH Shared drive (secure) and also in paper binders adhering to the IRB regulations.
• Ensure appropriate and secure back-up of all study data and other relevant files.
• Work with Department Sr. Research Manager and study sponsor (where appropriate) on problem recognition/resolution, accuracy of data gathered, and patient well-being, completion and collection of regulatory documents required by sponsors or department/ IRB regulations.
• Prepare for and participate in audits of studies including follow-up items as per IRB, FDA or Sponsor requirements as necessary.

• Strong organizational skills, high attention to detail, ability to work independently, and strong interpersonal skills to interact professionally and congenially with collaborators and study patients are a must.

• Bachelor's Degree in related discipline.
• Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.

• Experience in the Johns Hopkins system strongly preferred.
• Experience in phlebotomy.
• Intermediate knowledge of SAS or other statistical software preferred.
• Medical terminology and an advanced knowledge of Windows, Microsoft Office, Microsoft Access and Internet strongly preferred.

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria.