CASY-MSCCN Jobs

We are seeking a Sr. Research Program Coordinator who will coordinate multi- and single-center, federally- and industry-funded clinical research studies conducted in the ICU and post-ICU settings for the Division of Pulmonary and Critical Care Medicine. The coordinator will perform, train and/or supervise duties, including consenting, collecting and entering clinical data, and carrying out other related research duties for new and ongoing studies based in the ICU. The coordinator will prepare project progress reports, conduct literature searches, assist with manuscript preparation, and provide support for grant applications.

Specific Duties & Responsibilities

• Serves as the primary point of contact and liaison between PI, research staff, and budget office & Office of Research Administration at JHMI.

• Coordinates flow of communication between all entities involved in the research project.

• Manages administrative workflow to streamline the execution of contracts/subcontracts and protocol approval processes.

• Coordinate investigator meetings, data management meetings, meetings with study investigators and study sub-sites.

• Maintains detailed working knowledge of assigned protocols; design and compile materials, which aid investigators and other research staff in complying with protocol requirements.

• Oversee and conduct recruitment, screening, and enrolling of eligible patients into assigned protocols.

• Maintain regulatory binders/spreadsheets for assigned protocols. Prepare and submit change in research, annual renewals, amendments, and adverse event reports to IRB, DSMB, and sponsor (as applicable).

• Verifies patient eligibility for studies. Identifies study participants and is involved in their recruitment process on various clinical trials.

• Obtain informed consent from participants or their legally authorized representatives, explain assigned protocols in detail and conduct informed consent procedures according to required process and protocol eligibility criteria.

• Assist in the preparation of IRB, DSMB, and sponsor reports.

• Provides timely data and prompt notification of SAEs, protocol deviations, treatment delays and end of treatment visits.

• Coordinate serious adverse event reporting with the investigators to ensure prompt reporting to the IRB, DSMB, and study sponsor.

• Abstracts patient clinical and demographic data from a variety of sources (including paper and electronic medical records multiple electronic platforms) and enters into a CRF, tracking spreadsheet or database.

• Ensures accuracy and timeliness of data collection entry, management and analyses.

• Monitor compliance with data quality assurance and quality control goals of clinical studies and follows all written and unwritten study practices, procedures and protocols.

• Performs data management and analyses, including advanced use of spreadsheets and databases for studies.

• Reviews protocol amendments to identify changes to treatment orders, study calendar and risks to subjects. Lists and clarifies concerns & questions about new protocols with PI &/or sponsor.

• Communicates and collaborates with the PI, treating physician, study coordinators and other members of the study team on an ongoing basis regarding the implementation of the protocol and status of subjects.

• Participates in study initiation meetings. Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary. Writes responses to audit reports with input from the Principal Investigator.

• Prepares initial protocol submissions, develops consent forms and other regulatory documents in compliance with federal, university, departmental and other regulations.

• Maintain compliance with HIPAA and IRB regulations and guidelines.

• Assist in supervising multiple research staff involved in research activities.

• Administer standardized surveys to research subjects or their proxies via phone, or via in- patient, clinic or home visits.

• Prepares weekly report of work hours and activities for review by the supervisor.

• Demonstrates and serves as a role model for a positive work environment, including high motivation, positive attitude, and good judgment, tact, and sensitivity in all interpersonal interactions with all research staff, investigators, students and participants.

• Able to effectively prioritize and work on multiple tasks with concurrent deadlines and demonstrate excellent time management skills and efficiency.

Special Knowledge, Skills, & Abilities

• Excellent oral and written communication skills.

• Ability to work independently and manage multiple tasks, detail oriented, self-motivated, strong interpersonal skills.

• Excellent organizational and time-management skills.

• Ability to use personal computer, proficiency in Microsoft Word and Excel and database software (e.g. REDCap, ACCESS)

Technical Qualifications or Specialized Certifications

• Required - All IRB-required courses must be completed, and appropriate exams passed with necessary certification within 2 weeks of start date.

Physical Requirements

• Sitting in a seated position for extended periods of time.

• Reaching by extending hand(s) or arm(s) in any direction.

• Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.

• Ability to lift 40 lbs.

• Ability to attend to information presented one-on-one and during staff meetings.

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.

Preferred Qualifications

• Master’s Degree.

• Experience with multi-site clinical trials.

• Experience with budgeting, invoicing, NIH and/or Department of Defense research progress reports, IRB management.

• Petty cash disbursement and reconciliation experience.

• Experience using Redcap.

Classified Title: Sr. Research Program Coordinator

Job Posting Title (Working Title): Sr Research Program Coordinator

Role/Level/Range: ACRP/03/MB

Starting Salary Range: $40,900 - $71,600 Annually ($45,000 targeted; Commensurate with experience)

Employee group: Full Time

Schedule: 40

Exempt Status: Exempt

Location: School of Medicine - East Baltimore Campus

Department name: 10002817-SOM DOM Pulmonary

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.