Coord Research

St. Elizabeth Healthcare•Edgewood, KY

About The Position

Coordinate clinical research studies for the principal investigators and coordinates and promotes research program within St. Elizabeth and the community. Responsible for networking with physicians to open studies, educating staff about current studies, educating clients about studies and obtaining informed consents. Responsibilities include screening and enrolling subjects in studies and managing their participation according to ethical, regulatory, and protocol specific requirements. Responsibilities also include data collection and submission as well as Regulatory compliance. Demonstrate respect, dignity, kindness and empathy in each encounter with all patients, families, visitors and other employees regardless of cultural background. Coordinate clinical research studies conducted by the principal investigator. Perform study conduct in accordance with the protocol, manual of operations, and standard operating procedures (SOPs). Collaborate with physicians to open new studies at St. Elizabeth and to promote the research program within the community. Work directly with principal investigator to assist in the design of recruitment strategies, communication plan, patient safety monitoring plan, ensure compliance with protocol guidelines and requirements of regulatory agencies, including required documentation and record retention. Assist in coordinating study documents for review by the IRB and Sponsor. Conducts research studies according to Office for Human Research Protections (OHRP) and US Food and Drug Administration (FDA) regulations and guidelines. Follows Good Clinical Practices, Good Laboratory Practices, St. Elizabeth Healthcare policies, and maintains related certifications. Identify or assist in the screening of potentially eligible participants. Consent participants and coordinate, plan and execute study visits and provide instructions and reimbursement to participants. Conduct participant research visits and collect/record research related data. Submit data to study sponsors as required and document in the participant’s study chart as appropriate. Maintain the integrity and privacy of participant’s research protocol chart with all required source data. Demonstrate accuracy and organizational skills and the ability to follow through on requests and meet timelines. Communicate with study team and supporting clinical groups in professional and clear manner to support study activities. Assist with documentation and submission for approvals, revisions, renewals, informed consents, unanticipated problems, and study closure as mandated by the study sponsors, St. Elizabeth Healthcare, and the Institutional Review Board (IRB). Obtains patient biologic specimens or works with SEH laboratory/SEH clinical nursing staff to obtain laboratory specimens (blood, urine, saliva, etc.). Maintains IATA certification for the safe handling and shipping of biologic specimens. Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors. Performs other duties as assigned.

Requirements

Associate degree in related field with 2 years related experience OR Bachelors degree in related field
Understanding of research processes
Kind and Length of Experience: Dependent upon educational background. See Education, Credentials, and Licenses.

Responsibilities

Coordinate clinical research studies for the principal investigators
Coordinates and promotes research program within St. Elizabeth and the community
Networking with physicians to open studies
Educating staff about current studies
Educating clients about studies and obtaining informed consents
Screening and enrolling subjects in studies and managing their participation according to ethical, regulatory, and protocol specific requirements
Data collection and submission
Regulatory compliance
Perform study conduct in accordance with the protocol, manual of operations, and standard operating procedures (SOPs)
Collaborate with physicians to open new studies at St. Elizabeth and to promote the research program within the community
Work directly with principal investigator to assist in the design of recruitment strategies, communication plan, patient safety monitoring plan, ensure compliance with protocol guidelines and requirements of regulatory agencies, including required documentation and record retention
Assist in coordinating study documents for review by the IRB and Sponsor
Conducts research studies according to Office for Human Research Protections (OHRP) and US Food and Drug Administration (FDA) regulations and guidelines
Follows Good Clinical Practices, Good Laboratory Practices, St. Elizabeth Healthcare policies, and maintains related certifications
Identify or assist in the screening of potentially eligible participants
Consent participants and coordinate, plan and execute study visits and provide instructions and reimbursement to participants
Conduct participant research visits and collect/record research related data
Submit data to study sponsors as required and document in the participant’s study chart as appropriate
Maintain the integrity and privacy of participant’s research protocol chart with all required source data
Demonstrate accuracy and organizational skills and the ability to follow through on requests and meet timelines
Communicate with study team and supporting clinical groups in professional and clear manner to support study activities
Assist with documentation and submission for approvals, revisions, renewals, informed consents, unanticipated problems, and study closure as mandated by the study sponsors, St. Elizabeth Healthcare, and the Institutional Review Board (IRB)
Obtains patient biologic specimens or works with SEH laboratory/SEH clinical nursing staff to obtain laboratory specimens (blood, urine, saliva, etc.)
Maintains IATA certification for the safe handling and shipping of biologic specimens
Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors
Performs other duties as assigned