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Clinical Research Project Coordinator
Company | Kelly Science, Engineering, Technology & Telecom |
Address | Cincinnati Metropolitan Area, United States |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing,Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-08-25 |
Posted at | 9 months ago |
Kelly® Science & Clinical is seeking Clinical Research Project Coordinator for a Direct Hire position at a CRO client in the Cincinnati, OH area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Project Coordinator
Hybrid (3 days onsite, 2 days remote)
Cincinnati Metro area
Position Overview:
Under the supervision of an experienced Project Manager or designee, the Project Coordinator is responsible for assisting with coordination of research projects including protocol implementation, regulatory submissions, project planning, project tracking, and data collection and assisting in the creation of final reports and publications. Secondary responsibilities include assisting with the development and coordination of new projects.
Required Skills and Experience:
● Bachelor's Degree in a scientific or healthcare-related field or relevant experience
● Minimum of 3 years applicable experience required.
● Proficiency in Microsoft Office and experience with EDC systems
● Excellent communication, organizational, and interpersonal skills
Essential Functions/Responsibilities (other duties may be assigned):
● Works under the direction of experienced project clinical trial managers to assist with day-to day
operations of various research studies from trial start-up to database lock.
● Ordering and shipping of study supplies, working with the trial manager to provide supply cost estimates for study materials.
● Ensures adherence to federal or other regulatory requirements in accordance with ICH/GCP and SOPs.
● Coordinate teleconferences and team meetings, including agendas and other meeting materials.
● Assists in the development, implementation and coordination of study specific guidance documents.
● Coordinate all study specific training for the study team within electronic systems.
● Oversight of the Trial Master File (TMF), including management and coordination of the required TMF quality reviews.
● Under supervision, assists with development of study plans and provides overall project coordination, including progress tracking and reporting, quality control, recruitment and research support staff training.
● Coordinates all research project-related activities to assist the research team with meeting project goals and milestones, based on study design.
● Communicates resource needs, issues, project status and milestones met to project team and project leader.
● Assists with assigning access and maintaining electronic systems with up-to-date information.
● Develops and delivers study specific material such as tracking logs, templates, study binders, process manuals, etc.
● Submits requests for data extracts according to the study protocol and direction from the research investigator and project manager.
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