As we are expanding with additional projects, our research team is looking for an excellent self-motivated, goal-oriented, organized, team player Research Coordinator to 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 Principle Investigator of the project is Dr. Mostafa Borahay. Current project focuses on uterine fibroid research. The range of duties includes, but not limited to, Institutional Review Board (IRB) applications, 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 the work assigned 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.
Prepare and submit Institutional Review Board (IRB) applications, both new and renewal.
Follow all institutional research rules and guidelines.
Prepare and submit applications and communications with regulatory agencies as appropriate.
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 subjects as per protocol 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.
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.
Perform other duties as required.
Bachelor's degree in related discipline
Some related 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: 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.
Bachelor’s degree in a related field is required. Master’s degree in a related field is helpful but not required.
One (1) year of clinical, patient-oriented research experience. Additional education may substitute for experience. Additional experience may substitute for education.
Special Knowledge, Skills, and Abilities
Must maintain current required research 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.
Classified Title: Research Program Coordinator Working Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Hourly Pay Rate Range:16.26 - $22.35/ Commensurate with Experience Employee group: Full Time Schedule: Monday - Friday, 8:30 am - 5:00 pm / 40 hours per week Exempt Status: Non-Exempt Location: 04-MD:School of Medicine Campus Department name: 10002854-SOM OB GYN Bay Gynecology Obstetrics Bay Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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.
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