Job Description
POSITION SUMMARY:
An advanced member of the study team who under the direction of the Principal Investigator and Director of Research Operations is responsible for the overall coordination of assigned studies including screening, recruitment, data collection, and data entry to ensure protocol compliance and human subjects protection.
KEY ACCOUNTABILITIES:
- Serve as the primary coordinator on more-than-minimal-risk, high acuity, and/or complex studies. Serves as the liaison between study team, research cores/units/departments, ancillary hospital departments/services, sponsor, and IRB to ensure cross-communication and protocol compliance
- Delegate tasks to the Clinical Research Coordinator I and Research Assistant in accordance with the delegation of authority log to ensure study is executed appropriately and efficiently
- Coordinate the preparation and submission of regulatory documentation to the sponsor and Institutional Review Board (IRB) during all phases of study conduct including start-up, continuing reviews, changes in research, problem events, and closure to ensure human subjects protections and regulatory compliance
- Operationalize the recruitment plan and obtain or coordinate the informed consent process to ensure the participant understands the information and volunteers to participate free of coercion
- Coordinate and/or perform study visits/interventions/observations to ensure they are conducted according to protocol
- Monitor participants for adverse events and study conduct for protocol deviations and events and report accordingly to Principal Investigator, sponsor, and IRB to ensure participant safety and protocol compliance, and participate in the Corrective and Preventative Action planning where applicable
- Coordinate and perform data collection from various sources including medical records and enter data into research database to ensure accurate and timely data entry
- Maintain organized and up-to-date research records including regulatory binders and participant records to ensure study documentation is audit-ready
QUALIFICATIONS:
- Bachelors degree in science or health related field
- 3 years of prior clinical research coordination or nursing experience required
- Certified as a Clinical Research Professional, or will obtain CCRP within 6 months of becoming eligible, but no later than 2 years after hire
- Demonstrates knowledge and skills in accordance with Good Clinical Practice (GCP) guidelines, HIPAA, FDA regulations and other federally mandated guidelines
- Must be comfortable working with patient populations
- Computer competency in using Microsoft Office including Word, Excel, and Outlook; prior experience with Electronic Data Capture (EDC) systems or databases is preferred
- Ability to follow protocols and directions very closely
- Ability to grasp the rationale for the methods used and careful attention to details of the protocols
- Proficient knowledge of medical terminology and human subject research
- Ability to read, write, speak, and understand English
- Ability to communicate effectively, both verbally and in writing
- Ability to travel throughout the JHACH service areas in a timely manner.
Salary Range: Minimum /hour - Maximum /hour. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority.
We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices.
Johns Hopkins Health System and its affiliates are drug-free workplace employers.
Job Tags
Full time, Work at office,