Coordinate the conduct of Phase I through Phase IV clinical research studies in accordance with Good Clinical Practices (GCPs), International Harmonization Guideline and Standard Operating Procedures (SOPs) beginning with pre-study planning through successful completion of all study visits.
What You'll Do:
Maintain a good level of knowledge and understanding of assigned protocols, including all protocol requirements for study visits, obtaining informed consent, study visit schedules, tests, procedures, laboratory information, and drug accountability requirements
Recruit subject volunteers for studies; Work with the Recruitment Department with developing study-related materials and interview questionnaires
Create source templates for study documentation, complete case report forms, and other study specific documents seeking assistance from Senior Clinical Research Coordinator, Principal Clinical Research Coordinator, Team Leader or Clinical Site Director, as needed
Ensure consistency and effective communication during study visits and assure all procedures are conducted in compliance with the clinical protocol; Maintain subject safety, assess feedback from study participant and refer to investigators or other professionals as needed; If applicable, administer study medications based on state licensure, account for medications used
Coordinate and conduct study visits; Assure all procedures are conducted in compliance with the clinical protocol and in accordance with all applicable regulations and in compliance with GCPs
Interact with Investigators or study sponsors as needed to assure the study participant receives appropriate medical evaluation and care when needed
Interact with the sponsor Clinical Research Associate to facilitate the sponsor monitoring and database clean-up process
Attend sponsor Investigator/Study Coordinator meetings as needed for assigned protocols
Conduct clinical research in compliance with all applicable regulations; Request assistance and technical advice from Senior Clinical Research Coordinator, Principal Clinical Research Coordinator, Team Leader, or Clinical Site Director, as needed
Actively seeks out development opportunities
Behave cooperatively and constructively; Follow all company policies, state, local, federal, and other applicable laws and guidelines; Comply with all job-specific requirements
What You'll Bring:
1+ year of experience as a clinical research coordinator or in a similar position within the medical or mental health field
Bachelor’s degree in life sciences or equivalent combination of related experience and education in the medical or mental health field
Clinical Research Coordinator Certification (CCRC) is preferred
Associate or Bachelor’s Degree in Nursing is preferred
Advanced Cardiac Life Support (ACLS) is preferred
Why CTI?
Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.
Important NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page. Please Note
We will never communicate directly with you via Microsoft Teams Messaging or by text message
We will never ask for your bank account information at any point during the recruitment process
Equal Opportunity Employer/Veterans/Disabled
Numbers & Facts
Location
Cincinnati, Ohio
Skills
Advanced Cardiac Life Support (ACLS)unmatched
Biologyunmatched
Case Report Form (CRF)unmatched
Certified Clinical Research Coordinator (CCRC)unmatched
Clinical Adviceunmatched
Clinical Practices/Protocolsunmatched
Clinical Researchunmatched
Clinical Study Publicationsunmatched
Clinical Trialunmatched
Communication Skillsunmatched
Computer Telephony Integration (CTI)unmatched
Conduct Studiesunmatched
Data Cleaningunmatched
GCP (Good Clinical Practices)unmatched
Informed Consentunmatched
Medication Administrationunmatched
Medicationsunmatched
Medicineunmatched
Microsoft Product Familyunmatched
Nursingunmatched
Organizational Skillsunmatched
Plan Meetingsunmatched
Psychiatry and Mental Healthunmatched
Regulatory Complianceunmatched
Research Skillsunmatched
Short Messaging Service (SMS)unmatched
Standard Operating Procedures (SOP)unmatched
Team Lead/Managerunmatched
Technical Supportunmatched
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