Classified Title: Research Program Coordinator Working Title: Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.10-$22.12 Employee group: Full-Time Schedule: Working 40 hours per week; Monday-Friday 8:30-5pm Exempt Status: Non-Exempt Location: 04-MD:School of Medicine Campus Department name: 10002817-SOM DOM Pulmonary Personnel area: School of Medicine
The Research Program Coordinator will join our multidisciplinary team of physicians, nurses and data coordinators for both the lung transplant program in division of Pulmonary and Critical Care Medicine.
This position is a combination of laboratory and clinical skills for human research registries in lung transplantation, split approximately 50% clinical/regulatory and 50% lab sample processing. The candidate will join a team of 2 existing research coordinators in our group.
He/she will have an opportunity to interact with national leaders in the field, through our NIH funded multi- center studies, and contribute to study protocol implementation. The candidate will work with the Principal Investigators to organize and conduct research trials in the outpatient and inpatient settings. The research coordinator will be responsible for participant recruitment, enrollment, patient related study protocol procedures and regulatory procedures for human studies in the programs. Patient related procedures include the following: Organization, entry, and submission of accurate participant and field research data from medical records per protocol requirements.
Regulatory procedures includes assistance with IRB submissions, administering questionnaires and study materials in accordance with protocols.
Lab duties include: Serum and blood sample processing for subjects enrolled in research studies. While extensive lab expertise in molecular techniques or cell culture is not required, some experience in plasma, serum and basic cell processing would be helpful for this position. Our current coordinators can and will provide protocol specific training.
Optional opportunities include participation in data analysis, study design, preparation of scientific abstracts and manuscripts, based on candidate interest and time. However these opportunities are contingent on up to date completion of study protocol procedures, and not mandatory for the position.
Specific duties & responsibilities:
Maintains good working knowledge of all assigned protocols and reporting requirements.
Coordinate participant visits and follow-up, schedule appointments with study participants, make telephone reminders, send recruitment letters, track and locate participants.
Ensure that proper written informed consent from each study participant is obtained prior to entering study; ensure that the original signed and dated consent from each study participant is filed in participants' research record.
Design and maintain organizational tools to conduct the study accurately and in compliance with good research practice.
Maintain participant's follow-up tracking database; maintain records of study participants' status by using an enrollment log.
Maintain an organized filing system for electronic and paper-based research records according to HIPAA and IRB regulations and guidelines.
Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.
Administer survey questionnaires if mandated by study protocol.
Input clinical and biosamples data, organize, edit, and verify accuracy of data in databases.
Recruit and screen potential study participants according to protocol's inclusion and exclusion criteria; be knowledgeable of the protocol so that study activities are completed correctly and completely.
Completes minimum requirement for continuing educational units. Has working knowledge of and complies with JHU Research Office policies.
Provide assistance to the study supervisor in tasks relating to IRB submissions: completing progress reports, tracking of renewal dates, completing adverse event forms, writing draft forms.
Complete biosample processing including centrifugation, pipetting, plasma/serum cell freezing and biosamples freezing. Training can be provided.
Ensures laboratory efficiency by following set protocols for lab cleanliness, organization and safety regulations.
Cryopreservation of PBMC if requested by study protocol
Shipment of samples to outside labs per study protocol.
Monitors biohazard/radiation safety standards and proper handling of potentially hazardous chemical and biological agents in the workplace.
Keep the Clinical Research and Management System (CRMS) up to date with patient eligibility and enrollment in research studies.
Minimum Qualifications (Mandatory):
Required: Bachelor's degree in related discipline required. Additional experience may substitute for some education, and some additional education may substitute for experience.
Knowledge of medical terminology.
Special knowledge, skills, and abilities:
Ability to work independently and manage multiple tasks, detail oriented, self-motivated, strong interpersonal skills, ability to use personal computer; proficiency in Microsoft Word and Excel; database and spreadsheet knowledge.
Excellent oral and written communication skills and interviewing techniques required.
Detail oriented, Strong interpersonal skills and excellent organizational and time management skills required.
Carries out duties and responsibilities with limited supervision, but asks for clarification when needed regarding data quality and integrity issues and promptly notifies supervisors of any potential concerns regarding interactions with patients.
Technical qualifications or specialized certifications:
Must have current CPR certification. Standard HIPAA courses must be completed and appropriate exams passed with necessary certification within 2 weeks of start date
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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