Sr. Research Program Coordinator

Maintains good working knowledge of all assigned protocols and reporting requirements. Works on complex clinical studies which require a high level of knowledge, coordination, and data abstraction. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the Research Protocol Library. Maintains regulatory binder for each assigned protocol. 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 and/or program manager 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. Confirms patient registrations and relevant data points in databases for the Clinical Research Office and other relevant Information Systems. Maintains a research chart for each patient. Collects, enters and compiles clinical data from a variety of sources. Ensures accuracy and timeliness of data so that information may be used by the physician in treatment planning, presentations, and publication. Verifies scheduling of patient appointments, tests, and follow‑up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements. May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests. Meets regularly with IBD CTU Director, Principal Investigator, and other relevant personnel to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements. Will develop and maintain a protocol database or spreadsheet for tracking patient activity, financial management and data analysis as needed. Will meet with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. May participate in the development of invoicing schedules. Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies. Enters patient demographic and clinical data into institutional database as required. Responds in a timely manner to special projects or queries related to the data. 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. Completes minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Clinical Research Office policies. May instruct introductory level clinical research personnel in these guidelines and policies.

Minimum Qualifications (Mandatory):

Bachelor's degree in related discipline. A minimum of three (3) years’ related experience. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications:

BA/BS degree in Biological/Social Sciences or other appropriate discipline. A minimum of two (2) years’ experience in complex and detailed clinical trials/medical research. Graduate level course work or certification as a Clinical Research Professional preferred. Proficiency in the use of software applications, databases, spreadsheets, and word processing.

Excellent organizational skills required. Excellent attention to detail skills required. Knowledge of medical terminology required. Familiar with medical procedure and laboratory fees. Ability to manage multiple and competing priorities. Knowledge of clinical research practices and principles required. Ability to understand a clinical trail financial contract. Must have excellent time management skills. Must have excellent oral and written communication skills. Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information. Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general. Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.

Physical Requirements:

Sitting in normal seated position for extended periods of time. Ability to use a keyboard and move about. Ability to see and hear within normal parameters.

Classified Title: Sr. Research Program Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $38,820 - $53,520 annually (commensurate with experience)
Employee group: Full Time
Schedule: Mon-Fri, 40 hours/week
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: ​​​​​​​SOM DOM Gastroenterology
Personnel area: School of Medicine

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office atjhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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