Under the direct supervision of the Principal Investigator, the Sr. Research Program Coordinator is responsible for the generation, collection, organization, entry, maintenance, accuracy, and analysis of laboratory and clinical research data for molecular research on Barrett’s esophagus, a premalignant disease caused by chronic gastroesophageal reflux, as well as esophageal adenocarcinoma, squamous cell carcinoma, and gastric cancer. The Sr. RPC will maintain IRB protocols and perform laboratory biomarker experiments on patient-derived specimens. This role entails optimizing and executing wetlab experiments while acting as liaison with local and external collaborators for patient samples, collection of esophageal sponge and tissue samples, and their biobanking. Additionally, the Sr. Research Program Coordinator will collaborate in development, writing, and editing of IRB protocols and consent forms, in preparation of regulatory documents as appropriate, and in clarifying concerns & questions about new protocols with PI and/or sponsors, while also troubleshooting and performing wetlab experiments in the laboratory.
Specific duties & responsibilities:
The position is responsible for ensuring program quality, laboratory experimental execution, and adherence to expected processes and project goals and timelines.
Determines patient study eligibility, informed consent, patient randomization and enrollment.
Maintains good working knowledge of all assigned protocols and reporting requirements.
Follows HIPAA and IRB guidelines.
Collects, enters and compiles clinical data from a variety of sources.
Collects esophageal sponge, endoscopic biopsy, and surgical samples from research participants.
Prepares and stores specimens according to institutional and federal guidelines.
Gathers and documents into EPIC essential and accurate information about participant’s medical and medication history, patient reported outcomes, disease activity indices and laboratory and clinical data, after an appropriate period of training.
Processes samples using appropriate nucleic acid handling, digital and quantitative PCR assays.
Initiates and propagates organoid cultures, with subsequent manipulations including CRISPR-Cas9 editing, circular RNA construction, extracellular vesicle preparation, transfection, and animal model experiments.
Performs epigenetic biomarker assays using quantitative real-time PCR, methylation-on-beads, methylation-specific PCR, multiplexed PCR, and digital PCR.
Maintains efficiency of clinical and research flow among multiple physicians and other collaborators.
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.
Prepares, writes, edits, and submits manuscripts based on PI’s laboratory and clinical findings and surveys.
Assists PI and collaborators with data and writing for grant applications.
Designs and creates protocol-specific case report forms as needed.
Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies.
Ensures accuracy and timeliness of data collection so that information may be used by the PI in planning for grant writings, presentations and publication.
Participates in design of upcoming studies as well as analyses of data, performs basic statistical calculations and assists with preparation of reports, grant applications, abstracts and manuscripts related to PI’s projects.
Designs study database and develops quality control procedures to ensure accurate and timely data input.
Performs other duties as required.
Minimum qualifications (mandatory):
Bachelor’s degree in one of the biological science is required.
Minimum of two (2) years’ related experience.
Related experience in methylation-specific PCR biomarker work as well as IRB protocol preparation and modification.
Master’s degree in related discipline.
Five (5) years research experience and a familiarity with advanced research procedures and experimental protocol development and optimizations.
Special knowledge, skills, and abilities:
Must adhere to guidelines regarding honest reporting of sensitive and confidential research and participant information;
Understands the importance/impact of data integrity in terms of participants, study results, costs, quality of service and scientific research in general;
Regular contact with researchers and collaborators requires the use of good judgment, tact and sensitivity;
Excellent organizational and time management skills required;
Excellent interpersonal skills; Excellent oral and written communication skills required; Excellent attention to detail; Ability to manage multiple and competing priorities;
Proficiency in the use of standard software applications, databases, spreadsheets and word processing required.
Classified Title: Research Specialist II Working Title: Research Specialist II Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920- $53,917; commensurate with experience. Employee group: Full Time Schedule: M-F 8:30 -- 5:00 Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002808-SOM DOM Gastroenterology Personnel area: Johns Hopkins University
The successful candidate(s) for this position will be subject to a pre-employment background check.
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