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Research Assistant

Employer
Johns Hopkins University
Location
Maryland, United States
Salary
Salary Not Specified
Date posted
Sep 13, 2021

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The Department of Gynecology and Obstetrics is seeking a excellent self-motivated, goal-oriented, organized, team player to work as aResearch Coordinator. The selected applicant will be hired for a Full-Time Position in the Reproductive Sciences and Women’s Health Research division of the Department of Gynecology and Obstetrics; Monday – Friday 8 am-5 pm. The Principal Investigator of the project is Dr. James Segars. Current project focuses on clinical reproductive research. The range of duties includes, but not limited to patient recruitment, scheduling and conducting study visits, obtaining informed consent, data entry, and records management, expenditure oversight, collecting and processing bio-specimens, communicating with team members on the status of project. Candidate is expected to take ownership of laboratory work and be a trouble-shooter. Effective communication and interpersonal skills are critical as the position involves significant interaction with patients.

Specific Duties & Responsibilities:

    Will be involved in the research program including clinical trials in compliance with institutional and federal regulations. Get involved with the start-up phase through to the completion phase of the clinical trial. Will be involved in regulatory application, protocol implementation, compliance, recruitment, retention, and final completion of the trial. Complies with all regulatory/IRB guidelines including, but not limited to: preparation and submission of study protocols, consent forms, amendments, and annual continuing reviews. As such, will collaborate in development, preparation, and maintenance of regulatory documents; collaborate in determination of roles and responsibilities of study team members in the implementation of assigned clinical trials. Collaborate in the development of study tools including data collection forms, eligibility checklists, and pre-printed orders. Follow all institutional research rules and guidelines. Represent study team at study initiation meetings. Assist with organizing case report forms and regulatory binders. Screen potential research subjects for participation in clinical trials; evaluate ongoing eligibility of research subjects’ participation in clinical trials. Demonstrate an understanding of the informed consent process. Obtain informed consent from research subjectsas perprotocol and document obtaining of informed consent in the medical record. In conjunction with PI, monitor protocol enrollment goals and collaborate in the development of recruitment strategies to ensure accrual and retention within goal time frames; demonstrate knowledge of protocol endpoint definitions. Assist with ensuring collection of pertinent data from internal and external sources. Monitor compliance with requirements of assigned clinical trials. Maintain Data sources consistent with GCP guidelines and respective protocols. Obtain and ensure proper distribution of required pharmacokinetic & tissue samples. Schedule, perform, and/or monitor procedures and tests per protocol requirements. Ensure and coordinate correct documentation of clinical study in medical record and appropriate protocol documents. Schedule visits, tests and procedures for patients entered in clinical trials per the protocol. As appropriate, ensure all required signatures are obtained on informed consent documents and validity of available informed consent documents. Perform subject interviews and assessments at study visits for data collection required by protocol, as appropriate. Apply pharmacologic knowledge to assist PI in determining adverse event causality and relationship to study drug/procedure. As appropriate, performs phlebotomy per policy and procedures; and documents per institutional standards. Make return (~monthly) participant visits and coordination as well as, blood draws in addition to clinical assessments. High degree of understanding of research and applies general analytical skills to administer the logistical implementation of assigned projects, and to identify situations requiring special attention. Utilizing this knowledge, will ensure adherence to research protocols, operating procedures, and all associated internal/external regulations. Using working knowledge will assist in developing recruitment tools for assigned study(s), which include protocol/study specific data collection forms, drafting and placing approved advertisements, and contacting physicians for possible referrals. Develop moderately complex tracking database/spreadsheet based on study requirements utilizing Excel, REDCap, or similar software applications. Abstract data from patient medical records that requires some interpretation. Monitors data quality and accuracy as required by research protocol. Will run pre-established queries and may develop ad-hoc queries/reports as requested. Utilizing working knowledge of study(s) will participate in meetings to provide operational updates, report on any operational issues, and may make recommendations for resolutions to new/outstanding operational issues. Will coordinate study(s) meetings, including developing an agenda and coordinating information and participation of individuals from other institutions. Oversee budget expenditures based on the study(s) operational expectation. Will act as the primary contact for study participants, including scheduling, confirming appointments, and escorting/directing to various locations on/off campus. Ensure that case files and accompanying paperwork are organized and current. Assists with data analysis, interpretation, manuscript and abstract preparation. Although training in statistical analysis is not a requirement, familiarity with data analysis software is a plus. Opportunity for participation in scholarly activity and paper authorship.

Minimum Qualifications (Mandatory):

    Bachelor’s Degree in a related field is required. Master’s Degree in a related field is helpful but not required. Some related experience. One (1) year of clinical, patient-oriented research experience preferred. Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula. Must maintain currentrequiredresearch certifications during duration of employment. Completion of the JHH required training prior to start date. Ability to demonstrate knowledge and skills necessary to perform her role as it pertains to women reproductive health research. Able to prioritize workload and manage multiple projects effectively. Must achieve and maintain a working knowledge of computer software specific to department, including Microsoft Word and Excel, e-mail and internet functions and is knowledgeable of the Johns Hopkins Institutional Review Board and departmental Standard Operating Procedures.

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.

Classified Title: Research Assistant
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $16.42 - $22.57/hr (commensurate with experience)
Employee group: Full Time
Schedule: Monday - Friday, 8:30 am - 5:00 pm
Exempt Status: Non-Exempt
Location: School of Medicine Campus
Department name: ​​​​​​​Reproductive Science and Women's Health
Personnel area: School of Medicine

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office atjhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons or because the individual is pregnant or attempting to become pregnant. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

School of Medicine - East Baltimore Campus


The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

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