Research Program Coordinator

We are seeking a Research Program Coordinator who will assist the research team with the conduct of pharmaceutical sponsored clinical trials, long-term NIH-funded or other investigator-initiated research protocols examining the treatment and progression of disease in adults with HIV, hepatitis, COVID and other infectious diseases. The research will take place on the East Baltimore and Bayview Campuses.

Specific Duties & Responsibilities

• Develops recruitment and retention strategies for difficult and vulnerable populations.
• Identifies areas for improvement in clinical research infrastructure and addresses suggestions in collaboration with teammates and the Research Nurse Manager. Manages competing and shifting priorities effectively.
• Coordinates and leads site initiation visits for studies where Hopkins is a participating site in a multisite study, is the single site for an investigator-initiated study or is the Coordinating Center and our Pl is the Lead or Protocol Chair.
• Maintains communication with affiliate institutions to ensure high quality of data, timely submission of data, and adherence to guidelines.
• Serves as administrative, quality assurance, and as a regulatory contact for complex multi-center clinical trials for participating sites.
• Completes minimum requirement for continuing education units for professional growth and development.
• Maintains good working knowledge of all assigned protocols and reporting requirements.
• Transmits and distributes protocol information.
• Responsible for submission, verification, maintenance of protocol specific information to JHU eIRB and other central IRBs, as appropriate.
• Assists with the maintenance of 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 research nurse manager in defining information and plans required to accomplish goals of studies.
• May help design and create protocol- specific data collection forms.
• Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
• 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 can be used by the physician in treatment planning for individual patients, presentations and publication.
  
• Meets regularly with Principal Investigator, Research Nurse, and Research Nurse Manager to review data accuracy and overall study progress.
• Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and registry requirements.
• 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.

Physical Requirements

• Ability to stand, walk or sit for an extended period 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.
  
• Communication skills using the spoken word.
• Ability to see within normal parameters.
• Ability to hear within normal range.
• Possible exposure to communicable diseases.

• Bachelor's Degree in related discipline.

• Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.

• Some related experience preferred.
• Medical terminology and basic computer skills.
  

• Experience using PC and office suite software.
  

• Bio-specimen processing skills.

Special Knowledge, Skills, & Abilities

• Certification in appropriate skill groups must be obtained during introductory period.
  
• Knows the formal and informal departmental and divisional goals, standards, policies and procedures which may include some familiarity of other departments within the school/division.
• Is sensitive to the interrelationship of both people and functions within the department/divi