Play a key role as the lead research coordinator of the MIPLATE clinical trial. MIPLATE is an FDA-regulated multi-million dollar, randomized controlled clinical trial designed to study a novel blood product. May assist the PI with other research projects.
Duties and Responsibilities
Helps ensure that clinical research and related activities are performed in accordance with federal and institutional regulations, and in compliance with sponsoring agency policies and procedures.
Undergoes necessary training required to conduct research activities and maintains compliance with research policies.
Reviews and comprehends research protocols.
Identifies and screens potential candidates to determine eligibility for research study.
Interacts with (potential) research participants in an age-appropriate manner - to determine interest in the study, to collect focused medical history, to perform focused physical examination, to complete study-related forms and questionnaire, and to coordinate all study related activities including coordinating follow-up visits.
Documents required research-related notes in patient's medical records.
Professionally interacts with other study personnel and clinical team(s) to coordinate and enhance study activities.
Gathers data by interacting with patient, and review of patient's medical records. Responsible for data entry (typing/computer), database maintenance and reports.
Responsible for safeguarding and managing patient data in compliance with IRB regulations.
Keeps source documents organized and ready for internal and external audits.
Performs frequent and routine internal audits to ensure accuracy and completeness of study data.
Communicates with research subjects to respond to questions or concerns about studies.
May participate in daily operations of clinical and/or research protocols in collaboration with other staff.
Participates in meetings, as advised by the principal investigator.
Exchanges routine information in an appropriate manner requiring good verbal and written communication.
Professionally interacts and complies with the IRB, auditors and sponsors.
Completes IRB submissions.
Performs other activities necessary for successful conduct of research, as directed by the PI.
Supervision of Others: may be required to train and supervise other research coordinators and/or ancillary personnel.
Equipment, Machine, or Tool Requirements: Uses various software applications, such as spreadsheets, word and databases to assemble and/or format data and/or create test reports. Required to use the Johns Hopkins electronic patient records systems (training will be provided). Proficiency using electronic mail and internet is expected.
Requirements / Minimum Qualifications:
Education: Requires bachelor's degree in a field related to clinical medicine, e.g. laboratory science, physician assistant, nursing, or another related field.
3 years related experience required.
Knowledge and experience with FDA regulations and ICH GCPs for conducting clinical trials is preferred. Excellent verbal and written communication skills required. Excellent organizational skills, strong attention to detail and the ability to manage multiple tasks simultaneously required. Excellent interpersonal skills and cultural sensitivity required.
Special Knowledge, Skills, or Abilities / Competencies:
Ability to communicate with patients so that they can understand issues and ask appropriate questions.
Requires ability to move about facility, exam rooms, and offices as the need presents.
Requires ability to assist patients move from one position to another as needed.
Requires ability to observe and communicate with patient.
Requires ability to use computer to record and retrieve patient information. Attention to detail, accuracy of data, required.
Work Environment /While performing the duties of this job:
While performing the duties of this job, the employee may remain in a stationary position (sitting up to 70% of the time). The employee is required to operate computer keyboard for prolonged periods. The employee may be required to traverse/walk throughout large hospital campus to meet with patients.
**Position will require weekend and holiday support. Prolonged vision requirements including viewing computer screen, paper reports/documents, charts and results.
Clinical/Laboratory environment - Position works in patient care areas. Potential for personal injury or harm is minimized if established safety and health precautions are followed. Must refer to and are expected to comply with procedure manuals, follow proper laboratory protocols and safety policy/procedures, and be familiar with material data safety sheets in assigned work areas. Able to read and understand all Health, Safety and Environment (HSE) guidelines applicable to assigned work area. Working in laboratory where there may be discomforts due to odors, noise, temperature fluctuations, and working around lab equipment. Research areas may include animal, human, human products, DNA, and radiation protocols. Use of personal protective equipment may be advised or required.
Staff may` be required to complete annual competency review, and must insure compliance with Johns Hopkins Policy, Laboratory Policy & Procedure, Health, Safety & Environment regulations, and all applicable privacy & confidentiality laws/practices.
Classified Title: Sr. Research Program Coordinator Working Title: Clinical Research Coordinator ????? Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,921 - 53,519 commensurate with experience Employee group: Full Time Schedule: Mon - Fri - 8.30am - 5pm; Holiday and Weekend coverage required Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003067-SOM Pat Transfusion Medicine 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 at firstname.lastname@example.org. 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.
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