Research Program Assistant II

Johns Hopkins University

East Baltimore, MD

ID: 7071165
Posted: October 20, 2020
Application Deadline: Open Until Filled

Job Description

General Summary/Purpose

We are currently looking for a casual position for a Research Program Assistant II to work closely with the clinical research staff in the conduct of COVID -19 clinical trials. This individual will support both clinical and laboratory research operations in compliance with study protocol, standard laboratory operating procedures, and regulatory and JHU standards. The ideal candidate will have a mix of clinical and laboratory experience. A good fit for a Med Tech professional (e.g. EMT, CMA, PCT, phlebotomist, vascular access tech) interested in growing into a career as a clinical research professional. This position will afford an opportunity to experience all facets of conduct of early phase clinical trials, including work within FDA regulations and ICH Good Clinical Practice (GCP) guidelines.

Specific Duties & Responsibilities

Assisting study team with the implementation of COVID-19 research project(s)

Recruitment, screening, education, conducting informed consent, maintaining up to date knowledge of protocol(s) and protocol related SOPs.
Working within IRB and GCP guidelines.
Attending training sessions for IRB updates, Human subject’s protection, HIPAA, CPR, Bloodborne Pathogens and renewals as required by sponsor or university, and others as assigned.
Accurate completion of source documents / case report forms.
Data entry and report generation from computer programs such as medidata, REDCap and recruitment databases.
Attending meetings.
Willing to learn how to obtain and record vital signs.
Assisting and supporting other staff when necessary and knows when to seek assistance
Assist in maintaining and supplying the research sites.
Perform reasonable job duties, even if not part of the job description, as assigned by supervisor or Principal Investigator.
Complete annual CPR and other regulatory, clinical, and laboratory training and certifications as requested.
Other duties as assigned and requested by the PI and or research leadership team.

Clinical Research Laboratory operations

Research and clinical specimen collection (i.e., blood, urine, saliva, stool and nasal wash), testing and processing
Complying with universal safety precautions to protect self and co-workers from biohazardous materials, including blood-borne pathogens
Perform and document clinical laboratory testing
Specimen Preparation – printing specimen labels, labeling specimens
Coordinate manufacturer recommended calibration/maintenance of specimen freezers and refrigerators
Complying with laboratory QA/QC protocols and procedures and lab safety protocols
Maintain equipment maintenance logs

Minimum Qualifications (Required)

High School Diploma/GED.
Two (2) years related experience.
Phlebotomy: must be proficient with adult and children phlebotomy

Additional education may substitute for required experience, to the extent permitted by the JHU Equivalency Formula: 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. *

Preferred Qualifications

Preferred fluency in Spanish.
Certified Medical Assistant or Certified Laboratory Technology Certification preferred.
Certification as a registered Phlebotomist by a nationally recognized agency is preferred (e.g., National Center for Competency Testing, American Medical Technologists, American Society for Clinical Pathology, American Society for Clinical Pathology, American Society of Phlebotomy Technicians, National Phlebotomy Association).

Special Knowledge, Skills, and Abilities

Requires the ability to flex schedule at the supervisor’s request to work some evenings, nights or weekends as required
Will require travel to research sites as per study schedule
Must be comfortable using Microsoft office software such as Word, Excel and Outlook.
Occasionally lifting, carrying, pushing, and/or pulling objects weighing up to 50 lbs
Will require foot travel within the JHMI campus
Will require travel to outlying satellite sites
Duties may require standing, walking, or sitting for an extended period of time
Excellent interpersonal, written and verbal skills
Must have strong organizational skills with ability to work independently and prioritize multiple tasks
Prior training in and access to EPIC, an electronic medical record at Johns Hopkins Hospital, is a major plus.


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