Work Days/Hours: Monday - Friday, 8:30 a.m. - 5:00 p.m. (37.5 hours per week)
The Senior Research Program Coordinator is responsible for monitoring the collection, archiving, and analysis of research specimens from patients entered onto immunotherapy-related research protocols at JHH and possibly at external institutions. Responsible for the organization, entry, maintenance, and accuracy of all patient pathology data as it relates to clinical trials and restrospective studfies in a timely and ongoing manner. This data will be used to generate specific study findings after the data is analyzed. This includes the creation and maintenance of various databases. Oversee the hiring of research coordinators and subsequently become their supervisor.
Essential Job Functions:
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.
Creates and maintains a database for all samples collected and analyzed.
Block and slide management/shipping - Will serve as the specimen coordinator for material received and analyzed as part of external collaborations and/or clinical trials. This may entail database creation, logging of specimens, engaging Johns Hopkins Translational Services (when necessary), invoicing vendors, and overseeing the shipment of specimens, among other associated tasks.
Maintains regulatory documents and tracks specimens for each assigned protocol. In cooperation with investigators, prepares and submits annual renewal requests, IRB amendments, and potentially liaises with Sponsors of trails regarding specimen requirements. Adheres to all protocol requirements to ensure the validity of the clinicopathologic data.
Assist the principal investigators in defining information and identifying pathologic specimens required to accomplish goals of studies. May help design and create protocol specific data and specimen collection forms with assistance.
Verifies patient eligibility for studies by comparing patient history and clinical laboratory and surgical pathology results with protocol or study requirements. Manages relevant data points in databases for studies.
Maintains research records for specimen. 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 principal investigator(s) in treatment planning for individual patients (in the case of clinical trials), or presentations and publications. Maintains a protocol database or spreadsheet for tracking patient specimens and their analysis in respective laboratories. This may also require related data submission to internal and/or external registries.
Verifies scheduling of patient appointments for specimen acquisition 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.
Attendance during the specimen acquisition process may be essential in some instances to ensure proper handling and storage. This may include after-hours procedures, such as fine needle aspirations or rapid autopsy research protocols, and ensuring that the specimens are handled to the appropriate laboratory spaces for processing and analysis.
Oversee the hiring of research coordinators and ultimately serve as their supervisor.
Meets regularly with Principal Investigators and research staff to review specimen acquisition, analysis by different laboratories, related data accuracy, and overall study progress.
Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies. Enters patient demographic and clinical pathologic data into institutional database as required. Responds in a timely manner to special projects or queries related to the data.
Completes minimum requirement for continuing educational units. Has working knowledge of and complies with all applicable guidelines for ethical research and research policies at Johns Hopkins.
Selects, develops, performs and evaluates research methods; operates appropriate equipment. Uses sterile techniques to avoid contaminating lab experiments related to specimens acquired.
Uses various software applications, such as spreadsheets, relational databases, electronic mail, Word Wide Web, statistical packages, and graphics packages to assemble, manipulate and/or format data and/or test reports.
Analyzes data, formulates conclusions and creates appropriate statistical presentations, including graphs and charts, for the purpose of reporting research/laboratory results.
Monitors inventory levels and proper storage of materials and supplies in accordance with established policies and procedures. Keeps current knowledge of vendors and suppliers of materials specific to the laboratory requirements. Monitors equipment performance and maintenance schedules. May perform routine repair or replacement of standard parts.
Scope of Responsibility:
Responsible for the conduct of research testing in the clinical research setting. 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, and within the Department. Functions as a member of a team, working to promote an atmosphere of respect, collegiality, integrity and discovery, and supports ethical conduct of human research principles.
Exercises managerial or professional judgment and assumes complete responsibility for decisions, consequences, and results. Engages in regular and continuous decision making having an impact on people, costs, and/or quality of service.
Carries out duties and responsibilities with limited supervision by the principal investigator(s). Makes decisions and establishes work priorities. Exchanges non-routine information using tact and persuasion as appropriate requiring good oral and written communications skills. Practices service recovery and demonstrates service excellence in all aspects of the job.
BS/BA or equivalent, in biological sciences, chemistry, or physics, or related field required.
Three (3) years experience in a comparable laboratory performing relevant techniques, couple with survey knowledge of biological sciences, chemistry or physics required. Experience in pathologic specimen handling and database operations required. Additional graduate level courses may substitute for required work experience to the extent permitted by the JHU equivalency formula. Proficiency in PC operations and software application such as MS Windows, Excel, Word, Access. Ability to learn new database and software applications is required, specifically the Pathology Data System (PDS).
Sitting in a normal seated position for extended periods to time, standing for limited periods of time, walking for limited periods 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), fro example, using a keyboard.
Communication skills using the spoken word.
Ability to see within normal parameters and ability to hear within normal range.
Ability to move about.
This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for 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.
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