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 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, and maintenance of protocol-specific information to JHU elRB and other central IRBs, as appropriate.
- Assists with the maintenance of the 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 the 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 the 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 the 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.
Special Knowledge, Skills, & Abilities
- Certification in appropriate skill groups must be obtained during the introductory period.
- Knows the formal and informal departmental and divisional goals, standards, policies, and procedures, which may include some familiarity with other departments within the school/division.
- Is sensitive to the interrelationship of both people and functions within the department/division.
- Carries out duties and responsibilities with limited supervision.
- Reports to the Senior Research Manager. With the assistance of the Research Nurse Manager, makes decisions and establishes work priorities on procedures and strategically oriented operations.
- Excellent time management skills, organizational skills, and attention to detail.
- Excellent oral and written communication skills.
- Ability to follow multiple, detailed directions of various protocols and adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
- Understanding of the importance/impact of data integrity in terms of patients, study results, costs, quality of service, and scientific research in general.
- Due to regular contact with physicians and other health care personnel, and occasionally patients, the use of good judgment, tact, and sensitivity is strongly desired.
Minimum Qualifications
- Bachelor's Degree in a related discipline.
- Additional education may substitute for required experience and additional related experience may substitute for required education beyond HS Diploma/Graduation Equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
- Some related experience preferred.
- Medical terminology and basic computer skills.
- Experience using a PC and office suite software.
- Bio-specimen processing skills.
Classified Title: Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.20 - $30.30 HRLY ($40,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday to Friday 8:30am to 5pm
FLSA Status: Non-Exempt
Location: School of Medicine Campus
Department name: SOM DOM Bay Infectious Disease
Personnel area: School of Medicine