Research Program Coordinator
We are seeking a Research Program Coordinator who will work directly with the Research Program Manager, and Co-Director of the Success with Therapies Research Consortium (STRC) Data Management Core. The STRC is a multi-center consortium of academic research institutions that facilitates behavioral clinical studies to improve daily management of Cystic Fibrosis and to optimize health outcomes and quality of life, funded by the Cystic Fibrosis Foundation. The Coordinator is responsible for coordinating the research activities in a multi-center consortium, 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 to 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 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; 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.
- Be knowledgeable of the protocols to ensure proper completion of study activities.
- Conduct semi-structured interviews with participants at local site and/or other participating clinical center around the country.
- Participate in the qualitative analysis process (coding transcripts, code book development).
- Conduct assessments in a timely fashion via phone, in-person, or by web-based platform.
- 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.
- Assist in center staff training and monitor personnel training certification. May provide training and guidance to Research Assistant(s) and/or students.
- 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.
- 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.
- 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.
- Coordinate the distribution of adherence tracking devices to clinical centers, participants and companies.
- Maintain tracking systems for devices, parking vouchers, payment cards, and other study supplies.
- Adhere to guidelines regarding the sensitivity and confidential nature of patient information and data quality guidelines.
- Promptly notify supervisors of any potential concerns regarding interactions with patients.
- 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 consortium tasks as needed.
- Complete standard HIPAA courses and IRB course work.
- May be asked to work evenings and weekends. Limited amount of travel. Work from home will be allowed but required to be in office when asked.
Special Knowledge, Skills, & Abilities
- Solid understanding of research methodology, IRB, and GCP.
- 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.
- High level of organization, time management skills and ability to work on multiple projects simultaneously, while being able to prioritize and establish/meet deadlines.
- Able to carry out duties and responsibilities with limited supervision and ask for clarification when needed regarding data quality and integrity issues.
- 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.
Minimum Qualifications
- Bachelor's Degree in related discipline.
- Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
- Experience with social and behavioral health interventions and/or qualitative research preferred.
- Experience with multi-center studies preferred.
Classified Title: Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.00 - $30.00 HRLY ($40,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: Days, Evening, and Weekends
Exempt Status: Non-Exempt
Location: Hybrid/Johns Hopkins Bayview
Department name: SOM DOM Pulmonary
Personnel area: School of Medicine