The Dana Center for Preventive Ophthalmology at the Wilmer Eye Institute seeks a full-time Research Program Manager to join the Coordinating Center for multicenter clinical studies for eye diseases. This role will provide day-to-day management on research and administrative activities at the Coordinating Center of an NIH sponsored multicenter international clinical trial on eye disease. The Research Program Manager has a pivotal role in the Coordinating Center as the supervisor of overall quality assurance activities and Coordinating Center activities and plays an important role in facilitating an efficient, collaborative work environment at the Coordinating Center and facilitating professional and collaborative communications with clinical sites and other study units. The Research Program Manager will also manage the Wilmer Biostatistics Center requests and personnel availabilities on a daily basis.
Specific Duties & Responsibilities:
Clinical Trial Coordinating Center Responsibilities
To have a thorough knowledge of the Study protocol and the rationale behind the key design points, as well as knowledge of the key principles of clinical trials design and practice.
To supervise quality assurance activities at the Coordinating Center and clinical sites under supervision from the Director.
To provide supervisory support to the protocol monitors and if necessary telephone support to clinical site staff with questions regarding the Study protocol.
To supervise the day-to-day Coordinating Center activities in the areas of data collection, data processing, data reporting, data analysis, quality assurance and administrative support activities.
To perform some of site visits to the clinical sites and write summary reports.
To maintain a Log of Extraordinary Events for exceptional circumstances and significant deviations from the protocol.
To continually review and update the study MOP.
To supervise the production of the periodic reports required by the Study DSMC, Investigative Group, and Clinic Monitoring Committee.
In conjunction with the Protocol Monitor and Informatics Director, to monitor protocol adherence of clinical sites staff in submission of test materials to the Coordinating Center portal and their submission of specimens to the Central Laboratories or Coordinating Center as appropriate.
To plan and present the initial training for all Study Coordinators.
To oversee the production of the Study newsletters for patients and clinic staff.
To collaborate with other Study investigators to prepare Study findings for publication.
To act as director of the Coordinating Center in the temporary absence of the Director.
Wilmer Biostatistics Center (WBC) Responsibilities
To develop and manage the WBC service request intake platform.
To log service requests, track and document status of research projects.
To identify and maintain an up-to-date list of publications resulting from statistical services provided by the WBC.
To develop, continually review and update the WBC Standard Operating Protocol (SOP).
To monitor and manage incoming biostatistical service requests.
To oversee workload of each WBC statistician and coordinate assigning requests to WBC statisticians.
To communicate WBC news, SOP (Standard Operating Procedures) changes, and administrative updates with the Wilmer community.
To coordinate and moderate WBC team meetings.
Minimum Qualifications (Mandatory):
Bachelor's Degree in related discipline and at least 5 years of work experience.
Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.*
Demonstrated supervisory or lead responsibilities.
* JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
** Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Work experience (full-time or half-time) with multicenter studies.
Related Master's preferred.
Special Knowledge, Skills & Abilities:
Demonstrably strong organizational skills with attention to detail and independent follow through.
Familiarity with Microsoft software (e.g. Excel, Outlook, Teams), general computer and communications skills including telecommunications (e.g. Zoom meetings).
Flexibility with evolving study protocol and workflows.
Ability to shift between in-person and remote work as needed.
Able to positively contribute to a diverse workplace.
1 or 2 Research assistants.
Classified Title: Research Program Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $53,020 - $72,930 annually (commensurate with experience) Employee group: Full Time Schedule: Mon-Fri 8:30-5 Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM Oph Dana Center Personnel area: School of Medicine
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