Research - Laboratory/Non-Laboratory, Staff/Administrative
The Department of Rheumatology is seeking a Sr. Research Program Coordinator. Under the direct supervision of the Principal Investigator and other Senior Research staff, this position is responsible for monitoring and collection of all research data within the Division of Rheumatology’s Lupus Center. Specifically, they will serve as the primary staff member responsible for the organization, entry, maintenance, and accuracy of all clinical research data for several complex and detailed research studies, and may also assist with orientation and training of less senior research staff in protocol and clinical research information.
The Sr. Research Program Coordinator will also be the primary person responsible for coordination and implementation of assigned research projects within the Center’s research portfolio, and will anticipate requirements for designated patient populations. They may also collaborate in development and writing of protocols, consent forms, and other source documents and in the development and preparation of regulatory documents, as appropriate. This position will also clarify questions and concerns about protocols with the PI, other Senior Research staff and/or the sponsor, as needed. Lastly, the incumbent will be the primary point of contact for collaborating with data management staff on resolving edit queries and responding to data entry questions.
Specific Duties and Responsibilities:
Maintains good working knowledge of all assigned protocols and reporting requirements. Works on complex clinical and research studies which require a high level of knowledge, coordination, and data abstraction. Transmits and distributes protocol information to a team of research staff, faculty, and collaborators.
Assists PI in maintaining regulatory binders for assigned protocols. Prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data.
May assist the principal investigator in defining information and plans required to accomplish goals of studies. Will design and create protocol specific case report forms as needed. May also assist less experienced staff in design and creation of such forms.
Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
Advises and implements current recruitment and retention strategies for all protocols.
Collects, enters and compiles clinical data from a variety of sources. Ensures accuracy and timeliness of data so that information may be used by data managers/analysts and faculty members in grant writing, presentations, and publications.
May design and compile materials which aid the Principal Investigator/other staff in complying with protocol requirements.
Meets regularly with Principal Investigator, Program Manager, and Data Analyst to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned research studies.
Will develop and maintain a protocol database or spreadsheet for tracking patient activity, adherence to study timelines, and data collection.
Will participate with the Data Analyst and Biostatistician in resolving data queries and editing processing. Will also participate in data analysis as needed.
Will participate in drafting of manuscripts and grant applications as needed, including literature reviews and assisting with formatting manuscripts for journal submission guidelines.
Maintains tracking and ordering of supplies for clinical research studies.
May participate in the development of invoicing schedules.
Prepares for and participates in monitoring and audits of studies. Writes responses to audit reports with input from the Research Program Manager and Principal Investigator.
Completes minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies. May instruct introductory level research personnel in these guidelines and policies.
Bachelor’s degree in related discipline. Three (3)years related experience. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum experience required for the respective job.
Preferred Qualifications: Master’s degree, and may substitute for some experience, to the extent permitted by the JHU equivalency formula. Clinical trials/medical research and experience in the Johns Hopkins system strongly preferred. CCRP Certification preferred
Additional Knowledge, Skills, and Abilities:
Proficiency in the use of common software applications, databases, spreadsheets, and word processing required. Excellent organizational skills required. Excellent attention to detail skills required. Must have ability to manage multiple and competing priorities. Must have excellent time management skills. Must have excellent oral and written communication skills. Must be able to work independently. The successful applicant will demonstrate an ability to work well with other professionals with minimal supervision, and be comfortable being part of a diverse professional team.
Ability to stand, walk or sit for an extended periods of time. Finger Dexterity required to manipulate objects with fingers rather than with whole had(s) or arm(s), for example, using a keyboard. Ability to see within normal parameters. Ability to hear within normal range. Ability to lift 15 pounds.
Classified Title:Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920.00 - $53,520.00; Commensurate with experience Employee Group: Full Time Schedule: Monday - Friday, 8:30am - 5:00pm Exempt Status: Exempt Location: School of Medicine, East Baltimore Campus Department Name: Medicine Bayview Rheumatology Personnel Area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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