Clinical Research Coord (Non-RN) (Casual) - Research & Clinical Management
About The Position
This is a casual position which is subject to renewal by 06/30/2026 JOB SUMMARY: Under supervision, the Clinical Research Coordinator will be assigned to assist with multiple clinical research studies involving human subjects within the research unit/department. Assist with initiation, implementation and management of research projects in accordance with GCP, FDA, HIPAA & all required regulatory guidelines, with an emphasis on pediatric clinical research studies. Responsibilities may include initiating & managing multiple research projects, including but not limited to clinical trials, PI-initiated studies, and other research projects. Responsibilities may include but are not limited to: submission of protocols & renewals to IRB & scientific review boards; management & submission of electronic data forms to Sponsors, CROs & regulatory agencies; screening for eligibility; monitoring and timely reporting of adverse events; toxicities and protocol deviations; scheduling subjects' visits; coordinating clinical, laboratory and data management activities; processing and submitting laboratory specimens. Interfaces with patients/subjects & the Principal Investigators (PI) as well as working with assigned division's inpatient & outpatient clinical staff & other departments within the Institution. Coordinates preparation for monitor visits, regulatory & data audits. May support and/or supervise interns or staff depending on nature of study. If needed under study-specific research protocol, may collect basic vitals and clinical data based on study needs under the supervision and training of the study PI.
Requirements
- Bachelor's Degree Area of Study in a Field Related to the Position
- At least 2 years of experience in research/research-related activities
- Excellent oral and written skills
- General understanding of computer software and hardware: Word, Excel, data entry (ex. Any EDC platform such as REDCap, Medidata, Rave)
Nice To Haves
- Master's Degree
- 3 Years of Experience
- Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent Clinical research certification through SOCRA for ACRP
- Demonstrated ability and past experience in complex analysis, familiarity with statistical methodology
- Additional experience with preparation and submission of IRB applications, regulatory correspondence, and/or specific content of study related research
- 1-2 years of clinical trial experience
Responsibilities
- Assist with initiation, implementation and management of research projects
- Submission of protocols & renewals to IRB & scientific review boards
- Management & submission of electronic data forms to Sponsors, CROs & regulatory agencies
- Screening for eligibility
- Monitoring and timely reporting of adverse events; toxicities and protocol deviations
- Scheduling subjects' visits
- Coordinating clinical, laboratory and data management activities
- Processing and submitting laboratory specimens
- Interfaces with patients/subjects & the Principal Investigators (PI)
- Coordinates preparation for monitor visits, regulatory & data audits
- May support and/or supervise interns or staff depending on nature of study
- May collect basic vitals and clinical data based on study needs under the supervision and training of the study PI
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What This Job Offers
Career Level
Entry Level
Number of Employees
1,001-5,000 employees
