Research Program Coordinator
The Department of Medicine is seeking a Research Program Coordinator who will work under the direct supervision of the Program Supervisor or the Principal Investigator and will be responsible for participant recruitment for clinical studies/trials, performing clinical visits which include administering questionnaires, performing spirometry and other breathing tests, and collecting patient samples. The RPC will also be responsible for the organization, entry, maintenance and accuracy of all participants clinical and field research data in a timely and ongoing manner.

The candidate is responsible for coordinating the research activities, including collaborating with research team in the development of study protocols, manual of procedures, and electronic case report forms. Additional responsibilities include collecting research data include remote data capture and/or qualitative data, managing study databases, preparing reports, screening and recruiting eligible patients, and conducting literature searches.

Specific Duties & Responsibilities:

• Coordinate clinical research activities of protocols in the Adult Cystic Fibrosis research team.
• Develop and implement manual of procedures and standard operating procedures. Assist in database development and testing.
• Assist in creating forms and other study-related materials.
• Monitor compliance with data quality control goals of clinical studies and follows all written and unwritten study practices, procedures and protocols.
• Maintains detailed working knowledge of assigned protocols; design and compile materials which aid investigators and other research staff in complying with protocol requirements.
• Recruit and screen potential study participants according to protocols' inclusion and exclusion criteria.
• Conduct interviews over the phone or in person to determine eligibility for a research study.
• Ensure proper written informed consent from each study participant is obtained; ensure that the original signed and dated consent form for each study participant is filed in participants' research record. Maintain clinical site research study master files.
• Monitor visit and survey completion, inform participants of upcoming scheduled clinic and research appointments, and troubleshoot patient difficulties arising during visit assessments and manage concerns/issues about study procedures.
• Documents adverse events and protocol deviations. Register and pay participants through system.
• Perform vital study procedures such as venipuncture, pulmonary function testing and other breathing tests, and collection of vital signs. Perform routine tests in a research laboratory.
• This will include patient sample processing, such as blood and sputum processing. General maintenance of the laboratory, equipment, supplies, storage, shipping and receiving of specimens and transport of specimens if necessary.
• Design online surveys through Qualtrics software.
• Liaise between multiple collaborators and study team members, including physicians, clinic administrative staff, external collaborators, and/or vendors. Be responsible for the coordination of services and the communication of pertinent information to study participants.
• Assist in the preparation and maintenance of IRB applications and documentation, including new research submissions, annual continuing reviews, and amendments.
• Assist in the preparation and maintenance of DSMB, and sponsor reports as needed.
• 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.
• Input, organize, edit, and verify accuracy of data in databases. Run data queries as requested and provide routine study status reports. Responsible for tracking, quality control, and follow up with centers on outstanding data queries. Assist in developing and maintaining appropriate databases for current and future studies.
• Keep the Clinical Research and Management System (CRMS) up to date with patient eligibility and enrollment in research studies.
• Work independently and under the direction of the supervisor to ensure successful completion of each clinical research study. Maintain organizational tools to conduct the study accurately and in compliance with good research practice.
• Participate in routine staff meetings to report on recruitment progress and study-related issues. Recommend resolutions to new/outstanding operational issues.
• Assist in coordinating study-related meetings, including developing an agenda and reports and taking minutes. Track completion of action items.
• Adhere to guidelines regarding the sensitivity and confidential nature of patient information and data quality guidelines.
• Assist in the writing of post study data results and findings.
• Exhibits high level of organization, time management skills and ability to work on multiple projects simultaneously, while being able to prioritize and establish/meet deadlines
• Work independently and under the direction of the Research Program Manager to ensure successful completion of the clinical research study. Support the Research Program Manager and Principal Investigator in tasks as needed.

Minimum Qualifications (Mandatory):

• Bachelor's Degree in related discipline required.
• Some related experience required.

* Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Special Knowledge, Skills & Abilities:

• Solid understanding of research methodology, IRB, and GCP.
• Experience with social and behavioral health interventions and/or qualitative research, preferred.
• Ability to use personal computer; proficiency in Microsoft Office Suite; database and spreadsheet knowledge.
• Excellent oral and written communication skills and interviewing techniques.
• 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.
• Ability to function autonomously as part a collaborative interdisciplinary team.
• Advanced problem-solving skills, ability to think quickly and implement plans/structure for accomplishing work.
• Experience with multi-center studies preferred.

Technical Qualifications or Specialized Certifications:

• Standard HIPAA courses and IRB course work must be completed.

Physical Requirements:

• Sitting in a normal seated position in office setting.
• Standing and/or walking for extended periods of time.
• Lifting and/or assisting patients during evaluations within crowded clinical environment.
• Reaching by extending hand(s) or arm(s) in any direction.
• Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
• Communication skills using the spoken word.
• Ability to see within normal parameters.
• Ability to hear within normal range.
• Ability to move about.

Classified Title: Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $16.42 - $22.57/hr (commensurate with experience)
Employee group: Full Time
Schedule: M-F, 40 hrs
Exempt Status: Non-Exempt
Location: School of Medicine Campus
Department name: SOM DOM Pulmonary
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 Talent Acquisition Office at jhurecruitment@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. 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 campus. 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.

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To apply, visit https://jobs.jhu.edu/job/Baltimore-Research-Program-Coordinator-MD-21287/886384300/








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