Role/Level/Range: ACRP/03/MB 
Starting Salary Range: $38,536-$52,989
Employee group: Full-Time 
Schedule: M-F; 8:30am-5:00pm 
Exempt Status: Exempt  
Location: 33-MD:Johns Hopkins Bayview 
Department name: 10002817-SOM DOM Pulmonary 
Personnel area: School of Medicine

General Summary/Purpose:

Coordinates the administrative activities of clinical research studies in a multi-center consortium, including screening and recruiting eligible patients for study participation, collaborating with research team in the development of research instruments and forms, collecting research data and managing study databases, preparing reports, conducting literature searches, and assisting with grant and manuscript preparation.

Specific duties & responsibilities:

• Coordinate clinical research activities of protocols in consortium. Develop and implement manual of procedures and standard operating procedures. Assist in database development and testing. Assist in creating forms and other study-related materials.
• Conduct semi-structured interviews in person, over the phone, or via web services with participants at the local site and/or other participating clinical sites around the country. Participate in every stage of qualitative analysis process from creating a code book, to coding transcripts, to analyzing coded material. Responsible for coding quantitative and qualitative data using established procedures.
• Recruit and screen potential study participants according to protocols’ inclusion and exclusion criteria; be knowledgeable of the protocols to ensure proper completion of study activities. Conduct study visits over the phone, in person or by web-based platform.
• Conduct assessments in a timely fashion. Monitor visit and survey completion, inform participants of upcoming scheduled clinic and research appointments, and troubleshoot patient difficulties arising during visit assessments and manage concerns/issues about study procedures. Report adverse events. Register and pay participants through established electronic system.
• Ensure proper written informed consent from each study participant is obtained; ensure that the original signed and dated consent from for each study participant is filed in participants’ research record. Maintain clinical site research study master files.
• Liaise between multiple collaborators and study team members, including physicians, clinic administrative staff, and pharmacies locally and at participating clinical sites around the country. Be responsible for the coordination of services and the communication of pertinent information to study participants.
• Participate in routine staff meetings to report on recruitment progress and study-related issues. Recommend resolutions to new/outstanding operational issues. Assist in coordinating study-related meetings, including developing an agenda and reports and taking minutes. Track completion of action items.
• Assist in the preparation of IRBs, DSMB, and sponsor reports as needed. Run data queries as requested and provide routine study status reports.
• Train, and oversee research assistants and/or students as applicable.
• Adhere to guidelines regarding the sensitivity and confidential nature of patient information and data quality guidelines.
• Abstract data from archival audio, paper, and/or electronic records, such as pharmacy refill records and medical record abstraction. Input, organize, edit, and verify accuracy of data in databases. Responsible for data tracking and quality control. Follow up with clinics on outstanding data queries. Audit records as needed.
• Maintain tracking systems for devices, parking vouchers, payment cards, and other study supplies. Coordinate the distribution adherence tracking devices to clinical sites, participants and companies.
• Assist in clinical center staff training. Monitor personnel certification.
• Support the Research Program Manager and Principal Investigator in consortium tasks as needed.
• Exercise good judgment, tact, and sensitivity at all times while working in a busy hospital clinic environment.
• Work independently and under the direction of the research program manager to ensure successful completion of the clinical research study.

Minimum qualifications (mandatory):

• Bachelor’s degree in a related discipline.
• Three years’ related experience required.  Additional education may substitute for experience, to the extent permitted by the JHU Equivalency Formula

Preferred qualifications:

Special knowledge, skills, and abilities:

• Ability to work independently and manage multiple tasks
• Detail oriented, self-motivated, strong interpersonal skills
• Ability to use personal computer; proficiency in Microsoft Word and Excel; database and spreadsheet knowledge.
• Knows the informal policies, procedures, and practices necessary to conduct the normal function of a specific section, unit, or work area. Is aware of the role of the position and its potential impact on the working unit.

Technical qualifications or specialized certifications:

• Will need to complete IRB course work.

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 at jhurecruitment@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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