Sr. Research Program Coordinator
Company Name:
Johns Hopkins University
## General Description:
Responsibilities include management, organization, maintenance, data collection, and verification of all research data for various Chronic Obstructive Pulmonary Disease (COPD) studies.
Essential Job Functions:
Knowledge of protocols so that all study activities are completed correctly and completely ensure that studies are conducted according to all applicable regulations and guidelines and adhere to Standard Operating Procedures (SOPs) specified in the Protocol Manual
Ensure the safety, welfare and privacy of study participants
With the research team, write study protocols and procedures, create protocol manuals
Write and submit documents (applications, amendments, annual renewals) to the Institutional Review Board (IRB) and/or other regulatory agencies depending on the study sponsor; maintain regulatory binder
Develop recruitment strategies; create advertisements, meet with others to develop and revise methods; recruit and screen the potential study participants according the protocol's inclusion and exclusion criteria
Coordinate participant visits and follow-up; schedule appointments with study participants, send reminder letters, make telephone reminders, arrange for transportation; track and locate participants
Ensure proper written informed consent from each study participant is obtained prior to enrollment in a study; ensure that the original signed and dated consent for each participant with the appropriate participant identification, is filed in the participant's research record
Conduct participant visits, perform study procedures
Collect and record data (clinical evaluations, questionnaires, assessments, surveys, interviews, etc.); document on participant data forms
Oversee day to day activities of support staff. Train other site personnel and other medical staff in understanding and implementing study protocols
Design and maintain organizational tools to conduct the study accurately and in compliance with Good Research Practice/Good Clinical Practice (GCP)
Maintain adequate and accurate Case Report Forms (CRF) for each study participant that records all observations and data during the study; maintain adequate source documentation any document, form, or record where participant's data is first recorded
Develop data collection worksheets, forms and questionnaires as indicated
Develop participant follow-up database for tracking participant contacts; maintain records of study participants' status in the study by using an enrollment log
Abstract data from source documents; input, organize and edit data
Generate budgets (manage finances and petty cash account)
Evaluate study budgets and prepare cost-accounting materials for PRA patient cost-reimbursement analysis.
Act as liaison between multiple research collaborators; meet with outside contacts involved with studies (medical practices, industry representatives, etc.)
Develop and maintain filing system for participant records and other study documents
Manage study drug/device storage, dispensing, and accountability
Assign study participant ID numbers and maintain accurate and complete records of the receipt, dispensing, and return of all clinical supplies in order to note all discrepancies
Collect and process laboratory samples
Communicate and collaborate with sponsor, monitor, and site personnel regarding study activities as necessary
Travel to study sites, conduct home visits
Report all adverse events to the PI and Sponsor and serious or unexpected adverse events to the IRB
Perform administrative functions necessary: arrange for appropriate space and equipment, purchase supplies
Supervise preparation for all site visits from regulatory agencies by collecting and organizing all clinical sources of participant data pertinent to the clinical trial audit
Meet with the Sponsor's representatives to discuss the conduct of the study and review study data
Conduct staff meetings; take meeting minutes
Maintain and analyze database of research study participants and prepare statistical and graphical reports for analysis by federal Data and Safety Monitoring Boards as well as fulfilling reporting requirements to the FDA and local Institutional Review Board.
Perform pulmonary function tests for study participants; train site personnel in obtaining pulmonary function test certifications according to the American Thoracic Society (A.T.S.) guidelines; conduct quality control procedures for pulmonary function tests.
Ability to travel to various locations throughout Baltimore to conduct home visits when needed and attend study sites for training. Must have access to personal transportation. Valid driver's license required.
This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
This position is an essential position which requires the incumbent to work from home during an event (weather or otherwise) that causes JHU to curtail its operations by closing some or all the university's offices.
##
Qualifications:
Bachelor's degree in related discipline and Three years related experience required. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula. Valid driver's license required. CPR certification required or/ must obtain certification within three months of employment.
Proficiency in the use of software applications, databases, spreadsheets, and word processing required. Excellent organizational skills required. Excellent attention to detail skills required. Knowledge of medical terminology required. Ability to manage multiple and competing priorities. Knowledge of clinical research practices and principles required. Must have excellent time management skills. Must have excellent oral and written communication skills.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
## Preferred
Qualifications:
Experience in a hospital setting or other health care environment preferred. The Society of Clinical Research Associates (SOCRA) membership and certification preferred.
Requisition #: 63347
Role: ACRP
Level: 3
Range: MB
Status: Full Time
Hours Worked: 37.5
Work Week: Monday-Friday/8:30am-5:00pm
Contact: Lisa Beyer
Personnel Area: School of Medicine
Org Unit: Pulmonary
Location: Johns Hopkins Bayview Medical Campus
Approximate Starting Salary: $35,602 - $48,954Estimated Salary: $20 to $28 per hour based on qualifications.
Johns Hopkins University
## General Description:
Responsibilities include management, organization, maintenance, data collection, and verification of all research data for various Chronic Obstructive Pulmonary Disease (COPD) studies.
Essential Job Functions:
Knowledge of protocols so that all study activities are completed correctly and completely ensure that studies are conducted according to all applicable regulations and guidelines and adhere to Standard Operating Procedures (SOPs) specified in the Protocol Manual
Ensure the safety, welfare and privacy of study participants
With the research team, write study protocols and procedures, create protocol manuals
Write and submit documents (applications, amendments, annual renewals) to the Institutional Review Board (IRB) and/or other regulatory agencies depending on the study sponsor; maintain regulatory binder
Develop recruitment strategies; create advertisements, meet with others to develop and revise methods; recruit and screen the potential study participants according the protocol's inclusion and exclusion criteria
Coordinate participant visits and follow-up; schedule appointments with study participants, send reminder letters, make telephone reminders, arrange for transportation; track and locate participants
Ensure proper written informed consent from each study participant is obtained prior to enrollment in a study; ensure that the original signed and dated consent for each participant with the appropriate participant identification, is filed in the participant's research record
Conduct participant visits, perform study procedures
Collect and record data (clinical evaluations, questionnaires, assessments, surveys, interviews, etc.); document on participant data forms
Oversee day to day activities of support staff. Train other site personnel and other medical staff in understanding and implementing study protocols
Design and maintain organizational tools to conduct the study accurately and in compliance with Good Research Practice/Good Clinical Practice (GCP)
Maintain adequate and accurate Case Report Forms (CRF) for each study participant that records all observations and data during the study; maintain adequate source documentation any document, form, or record where participant's data is first recorded
Develop data collection worksheets, forms and questionnaires as indicated
Develop participant follow-up database for tracking participant contacts; maintain records of study participants' status in the study by using an enrollment log
Abstract data from source documents; input, organize and edit data
Generate budgets (manage finances and petty cash account)
Evaluate study budgets and prepare cost-accounting materials for PRA patient cost-reimbursement analysis.
Act as liaison between multiple research collaborators; meet with outside contacts involved with studies (medical practices, industry representatives, etc.)
Develop and maintain filing system for participant records and other study documents
Manage study drug/device storage, dispensing, and accountability
Assign study participant ID numbers and maintain accurate and complete records of the receipt, dispensing, and return of all clinical supplies in order to note all discrepancies
Collect and process laboratory samples
Communicate and collaborate with sponsor, monitor, and site personnel regarding study activities as necessary
Travel to study sites, conduct home visits
Report all adverse events to the PI and Sponsor and serious or unexpected adverse events to the IRB
Perform administrative functions necessary: arrange for appropriate space and equipment, purchase supplies
Supervise preparation for all site visits from regulatory agencies by collecting and organizing all clinical sources of participant data pertinent to the clinical trial audit
Meet with the Sponsor's representatives to discuss the conduct of the study and review study data
Conduct staff meetings; take meeting minutes
Maintain and analyze database of research study participants and prepare statistical and graphical reports for analysis by federal Data and Safety Monitoring Boards as well as fulfilling reporting requirements to the FDA and local Institutional Review Board.
Perform pulmonary function tests for study participants; train site personnel in obtaining pulmonary function test certifications according to the American Thoracic Society (A.T.S.) guidelines; conduct quality control procedures for pulmonary function tests.
Ability to travel to various locations throughout Baltimore to conduct home visits when needed and attend study sites for training. Must have access to personal transportation. Valid driver's license required.
This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
This position is an essential position which requires the incumbent to work from home during an event (weather or otherwise) that causes JHU to curtail its operations by closing some or all the university's offices.
##
Qualifications:
Bachelor's degree in related discipline and Three years related experience required. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula. Valid driver's license required. CPR certification required or/ must obtain certification within three months of employment.
Proficiency in the use of software applications, databases, spreadsheets, and word processing required. Excellent organizational skills required. Excellent attention to detail skills required. Knowledge of medical terminology required. Ability to manage multiple and competing priorities. Knowledge of clinical research practices and principles required. Must have excellent time management skills. Must have excellent oral and written communication skills.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
## Preferred
Qualifications:
Experience in a hospital setting or other health care environment preferred. The Society of Clinical Research Associates (SOCRA) membership and certification preferred.
Requisition #: 63347
Role: ACRP
Level: 3
Range: MB
Status: Full Time
Hours Worked: 37.5
Work Week: Monday-Friday/8:30am-5:00pm
Contact: Lisa Beyer
Personnel Area: School of Medicine
Org Unit: Pulmonary
Location: Johns Hopkins Bayview Medical Campus
Approximate Starting Salary: $35,602 - $48,954Estimated Salary: $20 to $28 per hour based on qualifications.
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