Johns Hopkins University
Sr. Research Coordinator
Johns Hopkins University, Baltimore, Maryland, United States, 21276
We are seeking a Sr. Research Program Coordinator who will be responsible for coordinating clinical research activities for nuclear medicine physicians and partnering principal investigators and co-investigators within the division. The Research Program coordinator will work collaboratively within a research team to promote quality and excellence of care, optimize team performance and achieve divisional clinical, research and organizational goals and outcomes.
Specific Duties & Responsibilities
Work with study Principal Investigators (PI) and serve as a liaison between multiple collaborators and disciplines to coordinate, supervise the day-to-day clinical research operations and data abstraction.
Responsible for coordination of services and communication of pertinent information to all study participants.
Ability to work with diverse study teams and patient population.
Monitor the clinical course of patients enrolled in clinical trials and ensures that research protocols are executed appropriately.
Track study activity on OnCore to accurately reflect study visits/ lab collections and other documentation.
Prepare for and participate in monthly monitoring visits and audits per sponsor study and ability to do so independently.
Assist PI with informed consent and implements research protocols through recruiting and enrolling eligible patients into studies.
Prepare relevant documents for Institutional Review Board and as well for EPIC tracking.
Assist the PI in overseeing and maintaining institutional and federal regulatory compliance, including preparing the IRB initial application, annual IRB continuing reviews, changes in research, protocol amendments, annual reports and events reports according to IRB requirements, and facilitates IRB audits.
Submit IND safety reports as needed to the IRB.
Collect research data and manage study databases as required by study protocols; enter data, control data quality and maintain research & data integrity.
Ability to resolve data queries as originated in the respective electronic data capture systems (EDC)
Prepare & present data and project progress to investigators, funding agencies, and necessary compliance authorities as requested/required by protocols.
Detect and assist in solving logistical & technical problems and the development and testing of research protocols.
Ensure PI and co investigators have current and relevant licensure and training.
Assist the administrator/research manager in tasks relating to IRB submissions: completing progress reports, tracking of renewal dates, completing adverse event forms, writing draft forms.
Assist clinicians with patient screening, consenting and verification of patient eligibility for studies as necessary.
Receive training in different skills such as ECG monitoring in order to conduct and complete specific research protocol requirements/ study visit milestones.
Work independently and under the direction of the supervisor to ensure successful completion of each clinical research study.
Dispense correct compensation to research participants for research study visits or milestones reached.
Maintain inventory of study related supplies.
Coordinate the training of other research staff in data management and the use of data collection instruments as necessary.
Develop and maintain organizational and educational tools for staff and subjects to conduct the study accurately and in compliance with good research practice.
Conduct collection, processing and shipping of biospecimen as requested by research protocols according to DOT/IATA regulations.
Maintain regulatory binders per protocol.
Document adverse events and protocol deviations.
Conduct 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.
Explain protocol procedures to research participants and obtain informed consent.
Schedule patients’ appointments and follow up visits/phone calls at the appropriate time to assure completion of protocol requirements, which may require coordination of multiple appointments and centers.
Design and compile materials and/or case report forms 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 study and follow-up visits.
Responsible for monitoring the clinical course and collection of research data on patients entered into research protocols.
Collect patient source documents and case report forms for analyzing patient data.
Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus.
Perform structured tests in the clinic and complete various assessment tools and questionnaires related to each study and ensure integrity of data collected as necessitated by particular protocols.
Assist in sample collection, sample delivery or shipment as and when needed by protocol specific procedures/ manual of operations.
Coordinate the collection and documentation of patient information for research purposes.
Maintain a research database of patients enrolled in clinical research.
Maintain regulatory binders per protocols.
Document adverse events and protocol deviations.
Complete necessary study training in order to be compliant with protocol needs, IRB needs and as well as for EDC or other interfaces.
Complete training requirements for biohazard material handling and department of transportation (DOT) shipping requirements.
Responsible for maintaining and promptly updating online Clinical Research Management System.
Assist with preparation of data for reports and respond in a timely manner to special projects or queries.
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 Abstract patient clinical and demographic information from a variety of sources and enter into tracking spreadsheet or data base.
Meet regularly with Principal Investigators and/ or Research Manager to review data accuracy and overall study progress and status.
Work with Supervisor, Center Directors and/or study sponsors on problem recognition/resolution, accuracy of data gathered, and patient well-being, completion and collection of regulatory documents required by sponsors.
Prepare for and participate in audits of studies including follow-up items.
Conduct periodic audits under the direction of the Research Program Manager and/or PI.
Schedule varies depending on study needs. Flexibility is a must.
Advanced arithmetic skills required.
Will work studies as per supervisor determination.
Minimum Qualifications
Bachelor's Degree in related discipline.
Three years related experience.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Classified Title: Sr. Research Program Coordinator
Job Posting Title (Working Title): Sr. Research Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $41,300 - $72,300 Annually ($60,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30a-5p
Exempt Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Rad Nuclear Medicine
Personnel area: School of Medicine
Equal Opportunity Employer:
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. The university promotes affirmative action for minorities, women, disabled persons, and veterans.
Specific Duties & Responsibilities
Work with study Principal Investigators (PI) and serve as a liaison between multiple collaborators and disciplines to coordinate, supervise the day-to-day clinical research operations and data abstraction.
Responsible for coordination of services and communication of pertinent information to all study participants.
Ability to work with diverse study teams and patient population.
Monitor the clinical course of patients enrolled in clinical trials and ensures that research protocols are executed appropriately.
Track study activity on OnCore to accurately reflect study visits/ lab collections and other documentation.
Prepare for and participate in monthly monitoring visits and audits per sponsor study and ability to do so independently.
Assist PI with informed consent and implements research protocols through recruiting and enrolling eligible patients into studies.
Prepare relevant documents for Institutional Review Board and as well for EPIC tracking.
Assist the PI in overseeing and maintaining institutional and federal regulatory compliance, including preparing the IRB initial application, annual IRB continuing reviews, changes in research, protocol amendments, annual reports and events reports according to IRB requirements, and facilitates IRB audits.
Submit IND safety reports as needed to the IRB.
Collect research data and manage study databases as required by study protocols; enter data, control data quality and maintain research & data integrity.
Ability to resolve data queries as originated in the respective electronic data capture systems (EDC)
Prepare & present data and project progress to investigators, funding agencies, and necessary compliance authorities as requested/required by protocols.
Detect and assist in solving logistical & technical problems and the development and testing of research protocols.
Ensure PI and co investigators have current and relevant licensure and training.
Assist the administrator/research manager in tasks relating to IRB submissions: completing progress reports, tracking of renewal dates, completing adverse event forms, writing draft forms.
Assist clinicians with patient screening, consenting and verification of patient eligibility for studies as necessary.
Receive training in different skills such as ECG monitoring in order to conduct and complete specific research protocol requirements/ study visit milestones.
Work independently and under the direction of the supervisor to ensure successful completion of each clinical research study.
Dispense correct compensation to research participants for research study visits or milestones reached.
Maintain inventory of study related supplies.
Coordinate the training of other research staff in data management and the use of data collection instruments as necessary.
Develop and maintain organizational and educational tools for staff and subjects to conduct the study accurately and in compliance with good research practice.
Conduct collection, processing and shipping of biospecimen as requested by research protocols according to DOT/IATA regulations.
Maintain regulatory binders per protocol.
Document adverse events and protocol deviations.
Conduct 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.
Explain protocol procedures to research participants and obtain informed consent.
Schedule patients’ appointments and follow up visits/phone calls at the appropriate time to assure completion of protocol requirements, which may require coordination of multiple appointments and centers.
Design and compile materials and/or case report forms 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 study and follow-up visits.
Responsible for monitoring the clinical course and collection of research data on patients entered into research protocols.
Collect patient source documents and case report forms for analyzing patient data.
Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus.
Perform structured tests in the clinic and complete various assessment tools and questionnaires related to each study and ensure integrity of data collected as necessitated by particular protocols.
Assist in sample collection, sample delivery or shipment as and when needed by protocol specific procedures/ manual of operations.
Coordinate the collection and documentation of patient information for research purposes.
Maintain a research database of patients enrolled in clinical research.
Maintain regulatory binders per protocols.
Document adverse events and protocol deviations.
Complete necessary study training in order to be compliant with protocol needs, IRB needs and as well as for EDC or other interfaces.
Complete training requirements for biohazard material handling and department of transportation (DOT) shipping requirements.
Responsible for maintaining and promptly updating online Clinical Research Management System.
Assist with preparation of data for reports and respond in a timely manner to special projects or queries.
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 Abstract patient clinical and demographic information from a variety of sources and enter into tracking spreadsheet or data base.
Meet regularly with Principal Investigators and/ or Research Manager to review data accuracy and overall study progress and status.
Work with Supervisor, Center Directors and/or study sponsors on problem recognition/resolution, accuracy of data gathered, and patient well-being, completion and collection of regulatory documents required by sponsors.
Prepare for and participate in audits of studies including follow-up items.
Conduct periodic audits under the direction of the Research Program Manager and/or PI.
Schedule varies depending on study needs. Flexibility is a must.
Advanced arithmetic skills required.
Will work studies as per supervisor determination.
Minimum Qualifications
Bachelor's Degree in related discipline.
Three years related experience.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Classified Title: Sr. Research Program Coordinator
Job Posting Title (Working Title): Sr. Research Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $41,300 - $72,300 Annually ($60,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30a-5p
Exempt Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Rad Nuclear Medicine
Personnel area: School of Medicine
Equal Opportunity Employer:
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. The university promotes affirmative action for minorities, women, disabled persons, and veterans.