Research - Laboratory/Non-Laboratory, Staff/Administrative
Coordinates the administrative activities of clinical research study, including coordinating advisory board meetings,, helping with the development of the intervention manual and materials, collaborating with research team in the development of research instruments and forms, screening and recruiting eligible patients for study participation, collecting research data and managing study databases, assisting with intervention delivery, preparing reports, conducting literature searches, and assisting with manuscript preparation.
Specific duties & responsibilities:
Coordinate advisory board meetings including taking minutes and tracking action items.
Assist investigators in developing the intervention manual and materials. Assist in intervention delivery.
Assist in developing and implementing the protocol, manual of procedures and standard operating procedures. Assist in database development and testing. Assist in creating forms and other study-related materials.
Recruit and screen potential study participants according to protocols’ inclusion and exclusion criteria; be knowledgeable of the protocol to ensure proper completion of study activities including survey administration, and 6 Minute Walk Test. Collect medication treatment plans and medical history including medical record abstraction. Conduct study visits over the phone, in person or by web-based platform.
Conduct post-intervention qualitative interviews with participants at local site and/or other participating clinical site. Participate in the qualitative analysis process (coding transcripts, code book development).
Conduct assessments in a timely fashion. 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. Report adverse events. Pay participants through approved system.
Ensure proper written informed consent from each study participant is obtained; ensure that the original signed and dated consent from for each study participant is filed in participants’ research record. Maintain clinical research study master files.
Liaise between multiple collaborators and study team members, including physicians, clinic administrative staff, and pharmacies at local institution and with University of Washington-Seattle. Be responsible for the coordination of services and the communication of pertinent information to study participants.
Assist in the preparation of IRBs, DSMB, and sponsor reports as needed. Run data queries as requested and provide routine study status reports.
Adhere to guidelines regarding the sensitivity and confidential nature of patient information and data quality guidelines.
Coordinate and participate in routine staff meetings including conference calls with site investigators and staff 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.
Input, organize, edit, and verify accuracy of data in databases. Responsible for tracking and quality control. Follow up with clinics on outstanding data queries. Audit records as needed.
Maintain tracking systems for devices, parking vouchers, and other study supplies. Coordinate the distribution adherence tracking devices to clinical sites, participants and companies.
Support the Principal Investigator on tasks as needed.
Exercise good judgment, tact, and sensitivity at all times while working in a busy hospital clinic environment.
Work independently and under the direction of the principal investigator to ensure successful completion of the clinical research study.
Scope of Responsibility: Knows the informal policies, procedures, and practices necessary to conduct the normal function of a specific section, unit, or work area. Is aware of the role of the position and its potential impact on the working unit.
Decision Making: Carries out duties and responsibilities with limited supervision. Makes decisions and establishes work priorities on essentially procedure-oriented operations.
Minimum qualifications (mandatory):
Bachelor's degree in related discipline required
Some related experience. Additional education may substitute for experience.
Two or more years of experience in a healthcare setting doing clinical research and/or behavioral counseling.
Special knowledge, skills, and abilities:
Experience with data collection, entry and management.
Excellent oral and written communication skills and interviewing techniques
Ability to exercise proper discretion and judgment.
Able to work effectively both in a team and independently.
Ability manage multiple tasks, efficient, detail oriented, and self-motivated.
Willing to work some evenings and weekends.
Proficiency in Microsoft Word and Excel; database and spreadsheet knowledge.
Technical qualifications or specialized certifications: Required: Will need to complete IRB course work.
Classified Title: Research Program Coordinator Working Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.10-$22.12 Employee group: Full Time Schedule: M-F; 8:30am-5:00pm Exempt Status: Non-Exempt Location: 33-MD:Johns Hopkins Bayview Department name: 10002817-SOM DOM Pulmonary 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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