Engage with us for your next career opportunity. Right Here.
Job Type:
RegularScheduled Hours:
40Job Summary:
Responsible to direct, coordinate and supervise all duties necessary for effective and compliant clinical research study coordination for multiple therapeutic areas, including planning, organizing, and managing all activities related to clinical research operations and execution of timelines.Demonstrate respect, dignity, kindness and empathy in each encounter with all patients, families, visitors and other employees regardless of cultural background.
Job Description:
- Serve in a mentoring and supervisory role as a resource for conducting clinical trials at St. Elizabeth. Lead activities as a recognized expert throughout the CRI for conducting complex clinical trials. Perform clinical research 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.
- Manage multiple complex trials and support regulatory team with preparation, review, submission, and maintenance activities. Lead monitor visits and audits. Act as an expert resource for regulatory activities related to research coordinator and research nurse roles for the CRI.
- Work with and supervise research study staff on complex trials for successful recruitment/enrollment and study conduct. Understand and identify barriers to successful patient recruitment and enrollment. Be able to communicate effectively to the Principal Investigator (PI) and sponsor regarding the progress of the trial.
- Document and maintain all study correspondence for the life of the clinical trial. Serve as a liaison to develop a clear communication and collaboration strategy for the CRI community for all clinical trials.
- Partner with CRI Leadership in strategic initiatives and growth/advancement of the CRI program. Be an active participant in the CRI advancement and development.
- Works with clinical departments and finance department to ensure appropriate billing/coding of study related activity. Assists with development of research billing grids, budgets, and monitoring of reimbursements.
- Performs other duties as assigned.
Education, Credentials, Licenses:
Bachelors degree AND Certification as a Clinical Research Professional (SOCRA, ACRP, etc.)
Specialized Knowledge:
- Study Conduct: Serve in leadership and mentoring role as a resource for others for aspects of conducting complex clinical trials. Directly or indirectly supervise research coordinators and/or research nurse staff involved in clinical research work.
- Regulatory Compliance: Manage multiple complex trials and support regulatory team with preparation, review, submission and maintenance activities. Lead monitor visits and audits. Act as an expert resource for regulatory activities related to research coordinator and research nurse roles for the St. Elizabeth Clinical Research Institute (CRI).
- Recruitment/Enrollment/Retention: Develop, implement, and execute recruitment strategies to identify potential participants for large, complex projects. Actively identify barriers to recruitment and implement strategies to solve them.
- Communication: Develop a clear communication and collaboration strategy for the CRI for all clinical trials
Kind and Length of Experience:
5 years directly related experience
FLSA Status:
ExemptRight Career. Right Here. If you're looking for the right careers in healthcare, the right place to be is at St. Elizabeth. Join us, and you'll take pride in the level of care we offer our community.
