Coordinates the activities of clinical research studies in a multi-center consortium, including screening and recruiting eligible patients for study participation, collaborating with research team in the development of research instruments and forms, collecting research data and managing study databases, preparing reports, conducting literature searches, and assisting with manuscript preparation.
Specific Duties & Responsibilities:
Coordinate clinical research activities of protocols in consortium.
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.
Recruit and screen potential study participants according to protocols’ inclusion and exclusion criteria; be knowledgeable of the protocols to ensure proper completion of study activities.
Conduct study visits over the phone, in person or by web-based platform.
Conduct semi-structured interviews with participants at local site and/or other participating clinical sites around the country.
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.
Register and pay participants through 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 site research study master files.
Liaise between multiple collaborators and study team members, including physicians, clinic administrative staff, and pharmacies.
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.
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.
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.
Responsible for requesting, tracking, and coordinating pharmacy refill records.
Collect medication treatment plans and medical history including medical record abstraction.
Maintain tracking systems for devices, parking vouchers, payment cards, and other study supplies.
Coordinate the distribution adherence tracking devices to clinical sites, participants and companies.
Assist in clinical center staff training. Monitor personnel certification.
Support the Research Program Manager and Principal Investigator in consortium 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 research program manager to ensure successful completion of the clinical research study.
Minimum Qualifications (mandatory):
Bachelor’s degree in related discipline required.
Some related experience required.
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***
Special Knowledge, Skills, and Abilities:
Ability to work independently and manage multiple tasks, detail oriented, self-motivated,
Ability to use personal computer; proficiency in Microsoft Word and Excel; 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.
Technical Qualifications or Specialized Certifications:
Standard HIPAA courses and IRB course work must be completed.
Any Specific Physical Requirements for the Job:
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
*** 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 required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Classified Title: Research Program Coordinator Working Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.26-$22.35 per hour Employee group: Full Time Schedule: Monday-Friday/8:30am-5:00pm/40 hours Exempt Status: Non-Exempt Location: 33-MD:Johns Hopkins Bayview Department name: 10002817-SOM DOM Pulmonary Personnel area: School of Medicine
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