Research Internal Monitor
Requisition #: 189825
Location: Johns Hopkins All Children's Hospital, St. Petersburg, FL 33701
Category: Non-Clinical Professional
Work Shift: Day Shift
Work Week: Full Time (40 hours)
Weekend Work Required: No
Date Posted: Aug. 21, 2019
Johns Hopkins Health System employs more than 20,000 people annually. When joining the Johns Hopkins Health System, you became part of a diverse organization dedicated to its patients, their families, and the community we serve, as well as to our employees. Career opportunities are available in academic and community hospital settings, home care services, physician practices, and international affiliate locations and in the health insurance industry. Great careers continually advance here.
Reporting directly to the Research Compliance Manager, the JHAC Research Internal Monitor functions autonomously as appropriate (but seeks appropriate supervision from leadership) in conducting routine internal monitoring of research studies and providing federal regulatory submission support (U.S. FDA and beyond) to clinical investigators across the organization, as assigned.
- Conduct routine internal monitoring to verify investigator and research staff adherence to standard operating procedures, institutional policies, federal guidelines, and international standards in clinical research.
- Under the direction of the Research Compliance Manager, assist in creation and dissemination of quality improvement tools (e.g. templates, checklists, guidance documents, etc.) and educational materials.
- Provide support to Research Compliance Manager (as assigned) for federal regulatory submissions and file maintenance pertaining to investigator-initiated clinical trials (e.g., FDA IND and IDE). Assist with other projects/functions related to research regulatory affairs, quality assurance, and federal regulatory submissions as assigned.
- Assist the Research Compliance Manager in the creation of presentations, modules, and tools for, as well as conduct education and training of investigators and research staff in, clinical research regulatory affairs—including but not limited to training on standard operating procedures and their relationship to institutional policies, federal guidelines, and international standards.
- Adhere to monitoring plan schedule (e.g. monitoring visit type, frequency, and required activities)
- Verify collected research data is consistent with source documentation.
- Meet expected timeline for completion of monitoring activities and submission of written monitoring reports.
- Assist in the development and writing of research monitoring plans.
- Provide recommendations and guidance to research teams and assist in audit readiness and preparation.
- Bachelor of Science degree in research or health-care related discipline is required.
- Minimum five (5) years of experience in conducting and/or monitoring clinical research.
- Prior monitoring experience a plus.
- Knowledge of clinical research federal guidelines and international standards.
- Proficiency with Microsoft Office suite electronic database applications is required.
- RAC, SOCRA, ACRP or equivalent certification is preferred.
- GCP training certification/recertification within 2 years is required, and must be renewed at least every 3 years (more frequently as required by institutional policy or standard operating procedures).
- Excellent organizational, communication, and teamwork skills are required. Strong communication skills as a point of contact for investigators and study coordinators.
- Ability to function autonomously and exercise appropriate judgement toward seeking supervision and/or collaboration.
PHYSICAL DEMANDS: (Please check all that apply)
- _____ Ability to move freely (standing, stooping, walking, bending, pushing and pulling) and lift up to a maximum of twenty-five (25) pounds without assistance.
- _____ Category 2: Job classification is not exposed to blood borne pathogens (blood or bodily fluids) while performing job duties.
- Office environment with some exposure to clinical areas.
Johns Hopkins Health System and its affiliates are an Equal Opportunity / Affirmative Action employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, mental or physical disability, genetic information, veteran status, or any other status protected by federal, state, or local law. Johns Hopkins Health System and its affiliates are drug-free workplace employers.
Johns Hopkins Medicine.